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Performance comparison of peripherally inserted central venous catheters in gastrointestinal surgery: A randomized controlled trial
Clinical Nutrition 31 (2012) 48e52
Contents lists available at SciVerse ScienceDirect
Clinical Nutrition journal homepage: http://www.elsevier.com/locate/clnu
Original article
Performance comparison of peripherally inserted central venous catheters in gastrointestinal surgery: A randomized controlled trial Hiromichi Miyagaki, Kiyokazu Nakajima*, Joji Hara, Makoto Yamasaki, Yukinori Kurokawa, Hiroshi Miyata, Shuji Takiguchi, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro Doki Department of Gastroenterological Surgery, Osaka University Graduate school of Medicine, 2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
a r t i c l e i n f o
s u m m a r y
Article history: Received 11 May 2011 Accepted 7 September 2011
Background & aims: Peripherally inserted central venous catheters (PICC) are long-term vascular access devices inserted through a peripheral vein of the arm and serve as an alternative to traditional central venous catheters. Currently different types of PICCs are available. No data, however, are available in regard to materials and tip designs. We designed a prospective, randomized trial comparing two major PICCs with different material and tip design: a silicone catheter with distal side slits (Groshong Catheter) and a polyurethane catheter with open-end tip (PI Catheter). Methods: Twenty-six patients who underwent PICCs placement between August 2010 and December 2010 were enrolled in the study. The primary endpoint was the completion rate of PICC indication. Secondary endpoints were complications rate. Result: The completion rate of PICC indication was not different significantly (81.8% and 92.9%, p ¼ 0.5648) and the total complication rate were also not different significantly (9.1% and 14.3%, P ¼ 1.0000) between two catheters. In detail, PI Catheter were associated with a significantly higher incidence of catheter occlusion, and Groshong Catheter were associated with a significantly hemorrhages after removal. Conclusion: There was no difference in the durability and the complication between Groshong Catheter and PI Catheter. (UMIN Clinical Trial Registry UMIN000005451). Ó 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Keywords: Peripherally inserted central venous catheters PICC Randomized controlled trial Gastrointestinal surgery Complication Polyurethane
1. Introduction The complications e.g. pneumothorax and hemorrhage, have been serious consequences following central venous catheter (CVC) placement with subclavian vein puctures.1e4 Peripherally inserted central venous catheters (PICCs) are long-term vascular access devices inserted through a peripheral vein of the arm, and has gained wider clinical acceptance as less-invasive alternative to traditional CVCs. The known advantages of PICCs are its introduction at the bedside, minimal pain at insertion, low rate of complications from its placement to removal,5 and lower infection rates compared to traditional CVCs.6e11 However, there remain a number of complications both at insertion and maintenance phases, 12 including catheter malposition,13 thrombosis,13e15 phlebitis,13,16 inadequate dripping, and line fracture.17,18
Abbreviations: PICC, Peripherally inserted central venous catheter; CR-BSI, catheter related blood stream infection; CVC, central venous catheter. * Corresponding author. Tel.: þ81 6 6879 3251; fax: þ81 6 6879 3259. E-mail address: [email protected] (K. Nakajima).
Currently, various types of PICC with different biomaterials and different specifications are commercially available. Despite widespread use in daily practice, however, there has been a lack in reliable data regarding the impacts of materials/specifications of PICC catheters on their performances: handleability, safety, and durability. We designed a prospective, randomized trial comparing two major PICCs with different material and tip design: a silicone catheter with distal side slits (Groshong, Bard Access Systems, Salt Lake City, UT, USA) and a polyurethane catheter with open-end tip (PI Catheter, Covidien, North Heaven, CT, USA), to compare their performances.
2. Materials and methods This study was approved by the Institutional Review Board of Osaka University Hospital. After the protocol was approved, a written informed consent was obtained from all patients prior to the entry into the study. All data obtained in this study were kept confidential. The study was registered at UMIN (http://www.umin. ac.jp; clinical trial no. UMIN000005451).
0261-5614/$ e see front matter Ó 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. doi:10.1016/j.clnu.2011.09.002
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
49
2.1. Patients
2.3. PICC catheters
Twenty-six consecutive patients, who underwent PICC placement for chemotherapy and/or perioperative intravenous nutritional support between August 2010 and November 2010, were enrolled in the study. The inclusion/exclusion criteria were shown in Table 1. A coordinating center in our institution was responsible for creating the treatment allocation code using a computergenerated randomization table. Treatment allocation was arranged prior to catheter placement. The patients were randomly assigned to either Groshong group or PI Catheter group, and following data were registered in the database: Age, Gender, Disease and Indication of PICC. The primary endpoint was the completion rate of PICC indication. Secondary endpoints were complications rate, e.g. blood stream infection, hemorrhage at the insertion site, phlebitis, vein thrombosis, and catheter malfunction such as partial/complete occlusion and fracture. The patients continued to be followed up until their discharge from the hospital.
Although both Groshong and PI Catheter have similar outer diameter (4 French size) and length (60 cm), a different material is used: silicone for Groshong and polyurethane for PI Catheter (Fig. 1). Both materials are less-thrombogenic therefore biocompatible, and have been validated as suitable for intravenous use. One characteristic of the polyurethane catheter is a larger internal diameter compared to the silicone catheter with same French size, which may lead to more stable and faster drip during infusion. On the other hand, the polyurethane catheter is harder than the silicon catheter. Although it softens with body temperature after insertion, this characteristic of PI Catheter might increase risk of phlebitis and thrombosis. One more critical difference between these two products is a tip configuration. Groshong has their patented three way “Groshong valves” distal to the closed semi-round tip. These valves remain closed when subjected to normal central venous pressure. When positive pressure is applied inside the catheter, the valves open to allow infusion. With negative pressure, the valves open in another way, allowing “aspiration” into the catheter. Whereas, PI Catheter has a simple, open end at its tip, no valves are equipped in the system. Table 2 depicts the differences of these two catheters including cost.
2.2. Data collection Patients were reviewed daily during their hospitalization. Data were recorded prospectively in a case report file (CRF). The following items in the CRF were recorded by an attending doctor: PICC insertion time, arm used, site of insertion, hemorrhage, tip location at confirmation fluoroscopy, and difficulty in catheter insertion/advancement. Additional information e.g. vital signs, duration of PICC placement, symptom of brachium, dripping condition during infusion, skin finding at a dressing site, any patient’s complaint about catheter placement, were obtained by an attending nurse. Any hemorrhage at the insertion site, i.e. bleeding within 24 h after insertion or after removal of PICC catheter, was also registered with a three-grade scale: “fair”, “little”, and “none”. The grade “fair” means the hemorrhage requiring pressure hemostasis for control, “little” as limited bleeding noted as coagulation formation in a dressing, and “none” as no observable bleeding. The catheter was removed prematurely when any catheter related blood stream infection (CR-BSI) was suspected according to Centers for Disease Control and Prevention guidelines.11 A catheter removal was also considered in case of complete occlusion or partial occlusion with drip disturbance. The tip of the removed catheter was carefully inspected and served for subsequent culture. Phlebitis-related complications were defined and scored as described by Maki et al.19
Table 1 Criteria of this study. Inclusion criteria 1. 2.
PICCa is needed clinically in chemotherapy or the intravenous-nutrition purpose newly Age between 20 and 80 years.
Exclusion criteria 1. 2. 3. a
Taking warfarin or an antiplatelet medicine within two weeks of an insertion day Past history of pulmonary embolism, deep vein thrombosis, and an endocarditis. Patients judged to be inappropriate as a subject
PICC: Peripherally inserted central venous catheter.
2.4. Procedure All PICCs were inserted by doctors under radiologic guidance without ultrasound. The patient was positioned in supine with his/ her arm extended and abducted at 90 or as tolerated. The arm was cleaned and draped with a tourniquet applied over the upper arm. A suitable vein in the mid arm was identified and entered using a 22-gauge venous cannula. A 0.018-inch guide wire was then passed through the cannula into the vein. After subcutaneous administration of 1% lidocaine for local anesthesia, the cannula was exchanged for a 4.5 French peelaway sheath, whichever catheter was selected. The catheter was then advanced through the peelaway sheath until the tip was located at the superior vena cava, under radiologic guidance. The sheath was peeled away, and the catheter was sutured through the suture wing onto the skin, close to the entry site. The puncture site was cleaned and covered with a clear sterile dressing. In a patient whose existing PICC failed, a new catheter was inserted through a different vein of the same arm or through a vein in the opposite arm. 2.5. Statistical analysis The differences between the two catheter groups for patient demographics, indication, underlying morbidity, procedural data, and outcome were investigated with Fisher’s exact test for categorical variables and student t test for continuous variables. These analyses were carried out using JMP version 8.0.1 (SAS Institute, Cary, NC, USA) for Windows. A P value of less than 0.05 denoted the presence of statistical significance. 3. Results The study was initially designed with 1:1 randomization and was scheduled to enroll 20 patients in each arm respectively. As Groshong arm became unable to be continued because of a recall due to insufficient product registration document, we were obliged to terminate this study at the time that 26 patients were enrolled in total. Twenty-five PICC placements were successful in 26 enrolled patients (success rate ¼ 96%). One failed patient had bilateral
50
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
Fig. 1. Specification of the catheters: Tip shapes and cross section. A: The tip of the Groshong catheter is a closed semi-round tip. The arrow indicates the side slits valve. B: The cross section of the Groshong catheter 4Fr. Outer diameter is 1.427 mm and inner diameter is 0.858 mm (measured). C: The tip of PI Catheter is a simple open-end. D: The cross section of the PI Catheter 4Fr. Outer diameter is 1.327 mm and inner diameter is 0.860 mm (measured).
brachial veins occlusion therefore required traditional CVC insertion from the jugular vein. They included a female and 25 male patients, with age ranging from 58 to 80 years (median 65.5 years). The most common underlying indication was chemotherapy or chemo-radiotherapy for advanced esophageal cancer, accounting for 96% of our total study population. The remaining reason of one case was a requirement of nutritional support due to prolonged postoperative leakage after total gastrectomy. No hematoma developed at the puncture sites in all patients during the procedures. There were no statistically significant differences in the patient demographics, included primary indication for PICC placement between Groshong and PI Catheter groups. Similarly, no significant differences in the arm used, insertion location, tip location, and duration of PICC placement, were noted (Table 3). The median catheter dwell time was 16 days (range, 9e39 days) for Groshong and 16 days (range, 5e52 days) for PI Catheter (p ¼ 0.9928). No difference was seen in either completion rate of PICC indication (81.8% vs. 92.9%, p ¼ 0.5648), nor total complication rate (9.1% vs. 14.3%, p ¼ 1.0000) between the two groups. Three cases were not able to complete their primary indications of PICCs placement, 2 in Groshong and 1 in PI Catheter group, respectively. In 2 cases in Groshong group, CR-BSI was suspected and the catheters were prematurely removed. There was no thrombus at the tip and the culture results were negative although one case alleviated fever immediately after the removal. In remaining 1 case in PI Catheter group, a significant catheter occlusion with thrombus was observed and a catheter was reinserted at the opposite arm. In addition to one case requiring premature removal, another case presented complete occlusion of the catheter in PI Catheter
Table 2 The characteristics of catheters.
Size Lumen Material Tip design Valve system Outer diametera Inner diametera Fixed priceb Manufacturer a b
Groshong Catheter
PI Catheter
4Fr Single Silicone Closed semi-round tip Three way “Groshong valves” 1.427 mm 0.858 mm 16,000 yen Bard
4Fr Single Polyurethane Simple, open end e 1.327 mm 0.860 mm 12,000 yen Covidien
Outer and inner diameter are measured for this study. Fixed prices of the catheters are in Japanese Yen.
group. Totally 2 out of 14 (14.3%) cases showed catheter occlusion in PI Catheter Group, whereas none in Groshong (p ¼ 0.4867). A phlebitis was noted in 1 case in each group, respectively (p ¼ 1.000). And both cases complained of a slight rubor and negligible pain to along a catheter dwelling vein. Within one day, those symptoms disappeared by acrinol poultice or cooling. All patients are examined by enhanced computed tomography for their disease but any thrombus in the peripheral and central veins was not pointed out (data not shown). Post-procedural hemorrhage was noted in 8 patients in Groshong group and 12 patients in PI Catheter group, respectively (p ¼ 0.2026). And hemorrhage for duration of PICC was noted in 3 patients in Groshong group and 4 in PI Catheter group. Most of them were minimal bleeding spontaneously controlled. Postremove hemorrhage was noted in 5 patients in Groshong group and no patients in PI Catheter group, respectively and there is significant difference (p ¼ 0.0017). (Table 4) 4. Discussion Our study showed no significant difference in the completion rate of PICC indication between the two different catheters in Table 3 Patient demographics, primary indications for PICCa placement and procedural data.
Registry case Placed case Gender Male/ female Age Median (range) Catheter dwell time (days) Median (range) Primary indication for PICCa Chemo or chemoradiotherapy Total parenteral nutrition Arm used Right Left Insertion location Antebrachial region Elbow portion Brachial region Catheter tip placement Superior vena cava a
Groshong
PI Catheter
12 11
14 14
p value
11/0
13/1
67 (58e80)
64.5 (56e80）
0.693
16 (9e39)
16 (5e52)
0.993 1.000
11 0
13 1
5 6
4 10
2 1 8
2 3 9
11/0
14/0
0.462 1.000
0.434
0.689
1.0000
PICC: Peripherally inserted central venous catheter.
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52 Table 4 Completion of Therapy and Complications. Groshong (n ¼ 11) The completion of PICCa indication Yes 9 Total complications 2 Phlebitis 1 Vein thrombosis 0 Blood stream infection 1 Occlusion 0 Hemorrhageb at site of insertion Post-procedural 8 Duration of PICC placement 3 Post-removal 5 Complaint of site of insertion and a brachial region. Yes 2
PI Catheter (n ¼ 14)
p value
13 2 1 0 0 2c
0.565 1.000 1.000 1.000 0.440 0.487
12 4 0
0.623 1.000 0.008
1
0.565
a
PICC: Peripherally inserted central venous catheter. b The hemorrhage with pressure hemostasis required or coagulation in a dressing materials. c Two occlusion cases were observed by PI Catheter, one case of them was observed on the date of the scheduled to remove, and was reported as a case which completed the indication.
gastrointestinal surgical patients. However, PI Catheter was associated with a significantly higher incidence of catheter occlusion, and Groshong was associated with a significantly higher incidence of hemorrhages after catheter removal. To our knowledge, there are no previous studies comparing performances of these two widely used PICC catheters. As for traditional CVCs, Linder et al reported that no significant differences were found between the silicon and polyurethane catheters regarding the number and size of radiologic thrombi in the peripheral and central veins, catheter occlusion rate, and platelet adhesion to the inner side of the catheter tip at removal.20 In our study, all patients were examined by enhanced computed tomography for their own disease within one month after removal, and any thrombus in the peripheral and central veins was not diagnosed. The thrombus formation in a catheter relates to development of CR-BSI.21,22 In hemodialysis patients, the rate of thrombus formation in the group with CR-BSI has been reported to be three times higher as compared with the group without CRBSI.23 A heparin administration as prophylaxis has been thus recommended.24,25 In our study, 2 cases with thrombus formation in a catheter were observed, only in PI Catheter group but there is statically no significant difference. As described in the report by Hoffer et al26 (Table 5), hypothetically this might be related to the absence of valve system rather than the difference in the material of the catheters. And the association of a thrombus formation and a blood stream infection was not recognized in this study. Although PICC has been reported to be associated with lower incidence of phlebitis and DVT compared to traditional CVCs,15 blood flow through the brachial vein is less than that through the
51
other central veins such as the subclavian or internal jugular. This feature, also in view of the smaller size of the vessel, and therefore the relatively larger intraluminal occupation, should be considered the main predisposing factor for PICC-related thrombosis. Groove et al. reported larger PICC diameter to be predictive of DVT.27 Simulation with annular flow model, PICCs by the insertion of a centrally located obstruction in a vein, dramatically decreased blood flow rates by as much as 93%.28 According to the adhesion model based on the JKR (Johnson, Kendall and Roberts) model theory,29 frictional and adhesion parameters between vein against silicone and polyurethane were reported by Prokopovich et al. The adhesive friction of vein to the silicone surface was more dominant than to polyurethane.30 Based on the previous study of comparing the silicone PICCs with a distal valve, and the polyurethane PICCs with a proximal valve, significantly higher incidences of phlebitis (23.2% versus 11.6%, P ¼ 0.003) and CR-BSI (6.2% versus 2%, P ¼ 0.043) were noted in the silicone PICCs.31 And the similar tendency in incidence of phlebitis/CR-BSI was seen in both our study and the trial by Hoffer et al.32 We have to recognize that the dwelling PICC in a vein is a very dangerous situation which can cause a thrombosis and CR-BSI. The low angiopathy polyurethane which can make an outer diameter small for obtaining the flow is more advantageous. Despite these data, we found no difference in phlebitis and DVT between two catheters. For this reason, the number of enrolled cases is small. In order to prove this, the further case accumulation will be required. More significant hemorrhage was observed in Groshong group than in PI Catheter group after catheter removal significantly. The contact reaction of a catheter with subcutaneous tissue might be one cause. More post-procedural hemorrhage was also observed in Groshong group, but not significantly. The difference in hardness and outer diameter could be also partially responsible for these differences. As listed in Table 5, to our knowledge, only 3 trials were reported previously. Besides our study, three of 4 trials that compared silicon and polyurethane revealed the inferiority in durability in silicon catheter. Hoffer et al.32 reported that fracture (i.e. partial or total disruption of catheter) was observed more frequently in silicon catheter group. Similar tendency was also reported by Ong et al.31 Probably, although the further case accumulation is required, since there is no difference of both catheters, the standpoint of medical economics will recommend a cheaper catheter. In conclusion, our study showed no significant difference in the completion rates of indication between a silicone catheter with distal side slits and a polyurethane catheter with open-end tip. A polyurethane catheter with open-end tip was associated with higher incidence of catheter occlusion, whereas a silicone catheter with distal side slits was associated with more significant hemorrhages at removal. A continuous accumulation of clinical cases is necessary to further clarify differences in performance of these two products in gastrointestinal surgical patients.
Table 5 Randomized controlled trial comparing peripherally inserted central venous Catheters. Author
Year
Cases
Size, lumens
Valve
Material
Phlebitis
CR-BSIb
Occlusion
Fracture
Hoffer26
1999
Hoffer32
2001
180 182 48 52 194 198 12 14
5Fr, 5Fr, 4Fr, 4Fr, 4Fr, 4Fr, 4Fr, 4Fr,
P None D P D P D None
Polyurethane Polyurethane Silicone Polyurethane Silicone Polyurethane Silicone Polyurethane
0.5% 0.0% 1.9% 0.0% 23.2%a 11.6%a 9.1% 7.1%
5.8% 5.8% 8.3% 1.9% 6.2%a 2.0%a 9.1% 0.0%
3.3% 7.1% 14.6% 9.6% 11.9% 9.6% 0.0% 14.3%
1.6% 1.1% 35.4%a 5.8%a 3.6% 1.0% 0.0% 0.0%
Ong
31
Present Study
2010 2011
single single single single single single single single
Valve type: D; distal side slits valve (GroshongÒ valve), P; proximal valve (PASVÒ Valve). a p value was reported significant (<0.05). b Catheter related blood stream infection.
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H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
Statement of authorship Hiromichi Miyagaki M.D. carried out the studies and data analyses, and drafted the manuscript. Kiyokazu Nakajima M.D. conceived of the study, participated in its design and coordination and drafted the manuscript. Joji Hara M.D. participated in this study design, carried out the studies and collection of data. Makoto Yamasaki M.D., Yukinori Kurokawa M.D., Hiroshi Miyata M.D. Shuji Yoshiyuki Fujiwara M.D. Takiguchi M.D. Prof. Masaki Mori and Yuichiro Doki M.D. are participated in provision of significance advice and consultation. Conflict of interest This study was supported financially by Nippon Sherwood Medical Industries Ltd. (Tokyo, Japan). The authors declare no further conflict of interest. Acknowledgements The authors wish to thank all attending doctors and nurses who participated in this study, and also thank all colleagues who advised us in carrying this study. References 1. Merrer J, De Jonghe B, Golliot F, Lefrant JY, Raffy B, Barre E, et al. Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial. Jama 2001;286:700e7. 2. McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123e33. 3. Ayas NT, Norena M, Wong H, Chittock D, Dodek PM. Pneumothorax after insertion of central venous catheters in the intensive care unit: association with month of year and week of month. Qual Saf Health Care 2007;16:252e5. 4. Eisen LA, Narasimhan M, Berger JS, Mayo PH, Rosen MJ, Schneider RF. Mechanical complications of central venous catheters. J Intensive Care Med 2006;21:40e6. 5. Leung TK, Lee CM, Tai CJ, Liang YL, Lin CC. A retrospective study on the longterm placement of peripherally inserted central catheters and the importance of nursing care and education. Cancer Nurs 2011;34:E25e30. 6. Ryder MA. Peripheral access options. Surg Oncol Clin N Am 1995;4:395e427. 7. Smith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg 1998;176:208e11. 8. Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc 1997;72:225e33. 9. Hadaway LC. Major thrombotic and nonthrombotic complications. Loss of patency. J Intraven Nurs 1998;21:S143e60. 10. Skiest DJ, Abbott M, Keiser P. Peripherally inserted central catheters in patients with AIDS are associated with a low infection rate. Clin Infect Dis 2000;30:949e52. 11. Kovacevich DS, Papke LF. Guidelines for the prevention of intravascular catheter-related infections: Centers for Disease Control and Prevention. Nutr Clin Pract 2003;18:95e6.
12. Haider G, Kumar S, Salam B, Masood N, Jamal A, Rasheed YA. Determination of complication rate of PICC lines in oncological patients. J Pak Med Assoc 2009;59:663e7. 13. Cowl CT, Weinstock JV, Al-Jurf A, Ephgrave K, Murray JA, Dillon K. Complications and cost associated with parenteral nutrition delivered to hospitalized patients through either subclavian or peripherally-inserted central catheters. Clin Nutr 2000;19:237e43. 14. King MM, Rasnake MS, Rodriguez RG, Riley NJ, Stamm JA. Peripherally inserted central venous catheter-associated thrombosis: retrospective analysis of clinical risk factors in adult patients. South Med J 2006;99:1073e7. 15. Bonizzoli M, Batacchi S, Cianchi G, Zagli G, Lapi F, Tucci V, et al. Peripherally inserted central venous catheters and central venous catheters related thrombosis in post-critical patients. Intensive Care Med 2011;37:284e9. 16. Mazzola JR, Schott-Baer D, Addy L. Clinical factors associated with the development of phlebitis after insertion of a peripherally inserted central catheter. J Intraven Nurs 1999;22:36e42. 17. Chow LM, Friedman JN, Macarthur C, Restrepo R, Temple M, Chait PG, et al. Peripherally inserted central catheter (PICC) fracture and embolization in the pediatric population. J Pediatr 2003;142:141e4. 18. Kothari D, Gupta S, Tandon N, Mehrotra A. Accidental cut of peripherally inserted central venous catheter. Intensive Care Med 2010;36:2154e5. 19. Maki DG, Botticelli JT, LeRoy ML, Thielke TS. Prospective study of replacing administration sets for intravenous therapy at 48- vs 72-hour intervals. 72 hours is safe and cost-effective. Jama 1987;258:1777e81. 20. Linder LE, Curelaru I, Gustavsson B, Hansson HA, Stenqvist O, Wojciechowski J. Material thrombogenicity in central venous catheterization: a comparison between soft, antebrachial catheters of silicone elastomer and polyurethane. JPEN J Parenter Enteral Nutr 1984;8:399e406. 21. Raad II , Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. Jama 1994;271:1014e6. 22. Timsit JF, Farkas JC, Boyer JM, Martin JB, Misset B, Renaud B, et al. Central vein catheter-related thrombosis in intensive care patients: incidence, risks factors, and relationship with catheter-related sepsis. Chest 1998;114:207e13. 23. Hernandez D, Diaz F, Suria S, Machado M, Lorenzo V, Losada M, et al. Subclavian catheter-related infection is a major risk factor for the late development of subclavian vein stenosis. Nephrol Dial Transplant 1993;8:227e30. 24. Randolph AG, Cook DJ, Gonzales CA, Andrew M. Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials. Bmj 1998;316:969e75. 25. Elliott TS, Curran A. Effects of heparin and chlorbutol on bacterial colonisation of intravascular cannulae in an in vitro model. J Hosp Infect 1989;14:193e200. 26. Hoffer EK, Borsa J, Santulli P, Bloch R, Fontaine AB. Prospective randomized comparison of valved versus nonvalved peripherally inserted central vein catheters. AJR Am J Roentgenol 1999;173:1393e8. 27. Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol 2000;11:837e40. 28. Nifong TP, McDevitt TJ. The effect of catheter to vein ratio on blood flow rates in a simulated model of peripherally inserted central venous catheters. Chest; 2011. 29. Johnson KL, Kendall K, Roberts AD. Surface energy and the contact of Elastic Solids. Proc R Soc Lond Ser A 1971;324:301e13. 30. Prokopovich P, Perni S. Prediction of the frictional behavior of mammalian tissues against biomaterials. Acta Biomater 2010;6:4052e9. 31. Ong CK, Venkatesh SK, Lau GB, Wang SC. Prospective randomized comparative evaluation of proximal valve polyurethane and distal valve silicone peripherally inserted central catheters. J Vasc Interv Radiol 2010;21:1191e6. 32. Hoffer EK, Bloch RD, Borsa JJ, Santulli P, Fontaine AB, Francoeur N. Peripherally inserted central catheters with distal versus proximal valves: prospective randomized trial. J Vasc Interv Radiol 2001;12:1173e7.
Contents lists available at SciVerse ScienceDirect
Clinical Nutrition journal homepage: http://www.elsevier.com/locate/clnu
Original article
Performance comparison of peripherally inserted central venous catheters in gastrointestinal surgery: A randomized controlled trial Hiromichi Miyagaki, Kiyokazu Nakajima*, Joji Hara, Makoto Yamasaki, Yukinori Kurokawa, Hiroshi Miyata, Shuji Takiguchi, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro Doki Department of Gastroenterological Surgery, Osaka University Graduate school of Medicine, 2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
a r t i c l e i n f o
s u m m a r y
Article history: Received 11 May 2011 Accepted 7 September 2011
Background & aims: Peripherally inserted central venous catheters (PICC) are long-term vascular access devices inserted through a peripheral vein of the arm and serve as an alternative to traditional central venous catheters. Currently different types of PICCs are available. No data, however, are available in regard to materials and tip designs. We designed a prospective, randomized trial comparing two major PICCs with different material and tip design: a silicone catheter with distal side slits (Groshong Catheter) and a polyurethane catheter with open-end tip (PI Catheter). Methods: Twenty-six patients who underwent PICCs placement between August 2010 and December 2010 were enrolled in the study. The primary endpoint was the completion rate of PICC indication. Secondary endpoints were complications rate. Result: The completion rate of PICC indication was not different significantly (81.8% and 92.9%, p ¼ 0.5648) and the total complication rate were also not different significantly (9.1% and 14.3%, P ¼ 1.0000) between two catheters. In detail, PI Catheter were associated with a significantly higher incidence of catheter occlusion, and Groshong Catheter were associated with a significantly hemorrhages after removal. Conclusion: There was no difference in the durability and the complication between Groshong Catheter and PI Catheter. (UMIN Clinical Trial Registry UMIN000005451). Ó 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
Keywords: Peripherally inserted central venous catheters PICC Randomized controlled trial Gastrointestinal surgery Complication Polyurethane
1. Introduction The complications e.g. pneumothorax and hemorrhage, have been serious consequences following central venous catheter (CVC) placement with subclavian vein puctures.1e4 Peripherally inserted central venous catheters (PICCs) are long-term vascular access devices inserted through a peripheral vein of the arm, and has gained wider clinical acceptance as less-invasive alternative to traditional CVCs. The known advantages of PICCs are its introduction at the bedside, minimal pain at insertion, low rate of complications from its placement to removal,5 and lower infection rates compared to traditional CVCs.6e11 However, there remain a number of complications both at insertion and maintenance phases, 12 including catheter malposition,13 thrombosis,13e15 phlebitis,13,16 inadequate dripping, and line fracture.17,18
Abbreviations: PICC, Peripherally inserted central venous catheter; CR-BSI, catheter related blood stream infection; CVC, central venous catheter. * Corresponding author. Tel.: þ81 6 6879 3251; fax: þ81 6 6879 3259. E-mail address: [email protected] (K. Nakajima).
Currently, various types of PICC with different biomaterials and different specifications are commercially available. Despite widespread use in daily practice, however, there has been a lack in reliable data regarding the impacts of materials/specifications of PICC catheters on their performances: handleability, safety, and durability. We designed a prospective, randomized trial comparing two major PICCs with different material and tip design: a silicone catheter with distal side slits (Groshong, Bard Access Systems, Salt Lake City, UT, USA) and a polyurethane catheter with open-end tip (PI Catheter, Covidien, North Heaven, CT, USA), to compare their performances.
2. Materials and methods This study was approved by the Institutional Review Board of Osaka University Hospital. After the protocol was approved, a written informed consent was obtained from all patients prior to the entry into the study. All data obtained in this study were kept confidential. The study was registered at UMIN (http://www.umin. ac.jp; clinical trial no. UMIN000005451).
0261-5614/$ e see front matter Ó 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. doi:10.1016/j.clnu.2011.09.002
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
49
2.1. Patients
2.3. PICC catheters
Twenty-six consecutive patients, who underwent PICC placement for chemotherapy and/or perioperative intravenous nutritional support between August 2010 and November 2010, were enrolled in the study. The inclusion/exclusion criteria were shown in Table 1. A coordinating center in our institution was responsible for creating the treatment allocation code using a computergenerated randomization table. Treatment allocation was arranged prior to catheter placement. The patients were randomly assigned to either Groshong group or PI Catheter group, and following data were registered in the database: Age, Gender, Disease and Indication of PICC. The primary endpoint was the completion rate of PICC indication. Secondary endpoints were complications rate, e.g. blood stream infection, hemorrhage at the insertion site, phlebitis, vein thrombosis, and catheter malfunction such as partial/complete occlusion and fracture. The patients continued to be followed up until their discharge from the hospital.
Although both Groshong and PI Catheter have similar outer diameter (4 French size) and length (60 cm), a different material is used: silicone for Groshong and polyurethane for PI Catheter (Fig. 1). Both materials are less-thrombogenic therefore biocompatible, and have been validated as suitable for intravenous use. One characteristic of the polyurethane catheter is a larger internal diameter compared to the silicone catheter with same French size, which may lead to more stable and faster drip during infusion. On the other hand, the polyurethane catheter is harder than the silicon catheter. Although it softens with body temperature after insertion, this characteristic of PI Catheter might increase risk of phlebitis and thrombosis. One more critical difference between these two products is a tip configuration. Groshong has their patented three way “Groshong valves” distal to the closed semi-round tip. These valves remain closed when subjected to normal central venous pressure. When positive pressure is applied inside the catheter, the valves open to allow infusion. With negative pressure, the valves open in another way, allowing “aspiration” into the catheter. Whereas, PI Catheter has a simple, open end at its tip, no valves are equipped in the system. Table 2 depicts the differences of these two catheters including cost.
2.2. Data collection Patients were reviewed daily during their hospitalization. Data were recorded prospectively in a case report file (CRF). The following items in the CRF were recorded by an attending doctor: PICC insertion time, arm used, site of insertion, hemorrhage, tip location at confirmation fluoroscopy, and difficulty in catheter insertion/advancement. Additional information e.g. vital signs, duration of PICC placement, symptom of brachium, dripping condition during infusion, skin finding at a dressing site, any patient’s complaint about catheter placement, were obtained by an attending nurse. Any hemorrhage at the insertion site, i.e. bleeding within 24 h after insertion or after removal of PICC catheter, was also registered with a three-grade scale: “fair”, “little”, and “none”. The grade “fair” means the hemorrhage requiring pressure hemostasis for control, “little” as limited bleeding noted as coagulation formation in a dressing, and “none” as no observable bleeding. The catheter was removed prematurely when any catheter related blood stream infection (CR-BSI) was suspected according to Centers for Disease Control and Prevention guidelines.11 A catheter removal was also considered in case of complete occlusion or partial occlusion with drip disturbance. The tip of the removed catheter was carefully inspected and served for subsequent culture. Phlebitis-related complications were defined and scored as described by Maki et al.19
Table 1 Criteria of this study. Inclusion criteria 1. 2.
PICCa is needed clinically in chemotherapy or the intravenous-nutrition purpose newly Age between 20 and 80 years.
Exclusion criteria 1. 2. 3. a
Taking warfarin or an antiplatelet medicine within two weeks of an insertion day Past history of pulmonary embolism, deep vein thrombosis, and an endocarditis. Patients judged to be inappropriate as a subject
PICC: Peripherally inserted central venous catheter.
2.4. Procedure All PICCs were inserted by doctors under radiologic guidance without ultrasound. The patient was positioned in supine with his/ her arm extended and abducted at 90 or as tolerated. The arm was cleaned and draped with a tourniquet applied over the upper arm. A suitable vein in the mid arm was identified and entered using a 22-gauge venous cannula. A 0.018-inch guide wire was then passed through the cannula into the vein. After subcutaneous administration of 1% lidocaine for local anesthesia, the cannula was exchanged for a 4.5 French peelaway sheath, whichever catheter was selected. The catheter was then advanced through the peelaway sheath until the tip was located at the superior vena cava, under radiologic guidance. The sheath was peeled away, and the catheter was sutured through the suture wing onto the skin, close to the entry site. The puncture site was cleaned and covered with a clear sterile dressing. In a patient whose existing PICC failed, a new catheter was inserted through a different vein of the same arm or through a vein in the opposite arm. 2.5. Statistical analysis The differences between the two catheter groups for patient demographics, indication, underlying morbidity, procedural data, and outcome were investigated with Fisher’s exact test for categorical variables and student t test for continuous variables. These analyses were carried out using JMP version 8.0.1 (SAS Institute, Cary, NC, USA) for Windows. A P value of less than 0.05 denoted the presence of statistical significance. 3. Results The study was initially designed with 1:1 randomization and was scheduled to enroll 20 patients in each arm respectively. As Groshong arm became unable to be continued because of a recall due to insufficient product registration document, we were obliged to terminate this study at the time that 26 patients were enrolled in total. Twenty-five PICC placements were successful in 26 enrolled patients (success rate ¼ 96%). One failed patient had bilateral
50
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
Fig. 1. Specification of the catheters: Tip shapes and cross section. A: The tip of the Groshong catheter is a closed semi-round tip. The arrow indicates the side slits valve. B: The cross section of the Groshong catheter 4Fr. Outer diameter is 1.427 mm and inner diameter is 0.858 mm (measured). C: The tip of PI Catheter is a simple open-end. D: The cross section of the PI Catheter 4Fr. Outer diameter is 1.327 mm and inner diameter is 0.860 mm (measured).
brachial veins occlusion therefore required traditional CVC insertion from the jugular vein. They included a female and 25 male patients, with age ranging from 58 to 80 years (median 65.5 years). The most common underlying indication was chemotherapy or chemo-radiotherapy for advanced esophageal cancer, accounting for 96% of our total study population. The remaining reason of one case was a requirement of nutritional support due to prolonged postoperative leakage after total gastrectomy. No hematoma developed at the puncture sites in all patients during the procedures. There were no statistically significant differences in the patient demographics, included primary indication for PICC placement between Groshong and PI Catheter groups. Similarly, no significant differences in the arm used, insertion location, tip location, and duration of PICC placement, were noted (Table 3). The median catheter dwell time was 16 days (range, 9e39 days) for Groshong and 16 days (range, 5e52 days) for PI Catheter (p ¼ 0.9928). No difference was seen in either completion rate of PICC indication (81.8% vs. 92.9%, p ¼ 0.5648), nor total complication rate (9.1% vs. 14.3%, p ¼ 1.0000) between the two groups. Three cases were not able to complete their primary indications of PICCs placement, 2 in Groshong and 1 in PI Catheter group, respectively. In 2 cases in Groshong group, CR-BSI was suspected and the catheters were prematurely removed. There was no thrombus at the tip and the culture results were negative although one case alleviated fever immediately after the removal. In remaining 1 case in PI Catheter group, a significant catheter occlusion with thrombus was observed and a catheter was reinserted at the opposite arm. In addition to one case requiring premature removal, another case presented complete occlusion of the catheter in PI Catheter
Table 2 The characteristics of catheters.
Size Lumen Material Tip design Valve system Outer diametera Inner diametera Fixed priceb Manufacturer a b
Groshong Catheter
PI Catheter
4Fr Single Silicone Closed semi-round tip Three way “Groshong valves” 1.427 mm 0.858 mm 16,000 yen Bard
4Fr Single Polyurethane Simple, open end e 1.327 mm 0.860 mm 12,000 yen Covidien
Outer and inner diameter are measured for this study. Fixed prices of the catheters are in Japanese Yen.
group. Totally 2 out of 14 (14.3%) cases showed catheter occlusion in PI Catheter Group, whereas none in Groshong (p ¼ 0.4867). A phlebitis was noted in 1 case in each group, respectively (p ¼ 1.000). And both cases complained of a slight rubor and negligible pain to along a catheter dwelling vein. Within one day, those symptoms disappeared by acrinol poultice or cooling. All patients are examined by enhanced computed tomography for their disease but any thrombus in the peripheral and central veins was not pointed out (data not shown). Post-procedural hemorrhage was noted in 8 patients in Groshong group and 12 patients in PI Catheter group, respectively (p ¼ 0.2026). And hemorrhage for duration of PICC was noted in 3 patients in Groshong group and 4 in PI Catheter group. Most of them were minimal bleeding spontaneously controlled. Postremove hemorrhage was noted in 5 patients in Groshong group and no patients in PI Catheter group, respectively and there is significant difference (p ¼ 0.0017). (Table 4) 4. Discussion Our study showed no significant difference in the completion rate of PICC indication between the two different catheters in Table 3 Patient demographics, primary indications for PICCa placement and procedural data.
Registry case Placed case Gender Male/ female Age Median (range) Catheter dwell time (days) Median (range) Primary indication for PICCa Chemo or chemoradiotherapy Total parenteral nutrition Arm used Right Left Insertion location Antebrachial region Elbow portion Brachial region Catheter tip placement Superior vena cava a
Groshong
PI Catheter
12 11
14 14
p value
11/0
13/1
67 (58e80)
64.5 (56e80）
0.693
16 (9e39)
16 (5e52)
0.993 1.000
11 0
13 1
5 6
4 10
2 1 8
2 3 9
11/0
14/0
0.462 1.000
0.434
0.689
1.0000
PICC: Peripherally inserted central venous catheter.
H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52 Table 4 Completion of Therapy and Complications. Groshong (n ¼ 11) The completion of PICCa indication Yes 9 Total complications 2 Phlebitis 1 Vein thrombosis 0 Blood stream infection 1 Occlusion 0 Hemorrhageb at site of insertion Post-procedural 8 Duration of PICC placement 3 Post-removal 5 Complaint of site of insertion and a brachial region. Yes 2
PI Catheter (n ¼ 14)
p value
13 2 1 0 0 2c
0.565 1.000 1.000 1.000 0.440 0.487
12 4 0
0.623 1.000 0.008
1
0.565
a
PICC: Peripherally inserted central venous catheter. b The hemorrhage with pressure hemostasis required or coagulation in a dressing materials. c Two occlusion cases were observed by PI Catheter, one case of them was observed on the date of the scheduled to remove, and was reported as a case which completed the indication.
gastrointestinal surgical patients. However, PI Catheter was associated with a significantly higher incidence of catheter occlusion, and Groshong was associated with a significantly higher incidence of hemorrhages after catheter removal. To our knowledge, there are no previous studies comparing performances of these two widely used PICC catheters. As for traditional CVCs, Linder et al reported that no significant differences were found between the silicon and polyurethane catheters regarding the number and size of radiologic thrombi in the peripheral and central veins, catheter occlusion rate, and platelet adhesion to the inner side of the catheter tip at removal.20 In our study, all patients were examined by enhanced computed tomography for their own disease within one month after removal, and any thrombus in the peripheral and central veins was not diagnosed. The thrombus formation in a catheter relates to development of CR-BSI.21,22 In hemodialysis patients, the rate of thrombus formation in the group with CR-BSI has been reported to be three times higher as compared with the group without CRBSI.23 A heparin administration as prophylaxis has been thus recommended.24,25 In our study, 2 cases with thrombus formation in a catheter were observed, only in PI Catheter group but there is statically no significant difference. As described in the report by Hoffer et al26 (Table 5), hypothetically this might be related to the absence of valve system rather than the difference in the material of the catheters. And the association of a thrombus formation and a blood stream infection was not recognized in this study. Although PICC has been reported to be associated with lower incidence of phlebitis and DVT compared to traditional CVCs,15 blood flow through the brachial vein is less than that through the
51
other central veins such as the subclavian or internal jugular. This feature, also in view of the smaller size of the vessel, and therefore the relatively larger intraluminal occupation, should be considered the main predisposing factor for PICC-related thrombosis. Groove et al. reported larger PICC diameter to be predictive of DVT.27 Simulation with annular flow model, PICCs by the insertion of a centrally located obstruction in a vein, dramatically decreased blood flow rates by as much as 93%.28 According to the adhesion model based on the JKR (Johnson, Kendall and Roberts) model theory,29 frictional and adhesion parameters between vein against silicone and polyurethane were reported by Prokopovich et al. The adhesive friction of vein to the silicone surface was more dominant than to polyurethane.30 Based on the previous study of comparing the silicone PICCs with a distal valve, and the polyurethane PICCs with a proximal valve, significantly higher incidences of phlebitis (23.2% versus 11.6%, P ¼ 0.003) and CR-BSI (6.2% versus 2%, P ¼ 0.043) were noted in the silicone PICCs.31 And the similar tendency in incidence of phlebitis/CR-BSI was seen in both our study and the trial by Hoffer et al.32 We have to recognize that the dwelling PICC in a vein is a very dangerous situation which can cause a thrombosis and CR-BSI. The low angiopathy polyurethane which can make an outer diameter small for obtaining the flow is more advantageous. Despite these data, we found no difference in phlebitis and DVT between two catheters. For this reason, the number of enrolled cases is small. In order to prove this, the further case accumulation will be required. More significant hemorrhage was observed in Groshong group than in PI Catheter group after catheter removal significantly. The contact reaction of a catheter with subcutaneous tissue might be one cause. More post-procedural hemorrhage was also observed in Groshong group, but not significantly. The difference in hardness and outer diameter could be also partially responsible for these differences. As listed in Table 5, to our knowledge, only 3 trials were reported previously. Besides our study, three of 4 trials that compared silicon and polyurethane revealed the inferiority in durability in silicon catheter. Hoffer et al.32 reported that fracture (i.e. partial or total disruption of catheter) was observed more frequently in silicon catheter group. Similar tendency was also reported by Ong et al.31 Probably, although the further case accumulation is required, since there is no difference of both catheters, the standpoint of medical economics will recommend a cheaper catheter. In conclusion, our study showed no significant difference in the completion rates of indication between a silicone catheter with distal side slits and a polyurethane catheter with open-end tip. A polyurethane catheter with open-end tip was associated with higher incidence of catheter occlusion, whereas a silicone catheter with distal side slits was associated with more significant hemorrhages at removal. A continuous accumulation of clinical cases is necessary to further clarify differences in performance of these two products in gastrointestinal surgical patients.
Table 5 Randomized controlled trial comparing peripherally inserted central venous Catheters. Author
Year
Cases
Size, lumens
Valve
Material
Phlebitis
CR-BSIb
Occlusion
Fracture
Hoffer26
1999
Hoffer32
2001
180 182 48 52 194 198 12 14
5Fr, 5Fr, 4Fr, 4Fr, 4Fr, 4Fr, 4Fr, 4Fr,
P None D P D P D None
Polyurethane Polyurethane Silicone Polyurethane Silicone Polyurethane Silicone Polyurethane
0.5% 0.0% 1.9% 0.0% 23.2%a 11.6%a 9.1% 7.1%
5.8% 5.8% 8.3% 1.9% 6.2%a 2.0%a 9.1% 0.0%
3.3% 7.1% 14.6% 9.6% 11.9% 9.6% 0.0% 14.3%
1.6% 1.1% 35.4%a 5.8%a 3.6% 1.0% 0.0% 0.0%
Ong
31
Present Study
2010 2011
single single single single single single single single
Valve type: D; distal side slits valve (GroshongÒ valve), P; proximal valve (PASVÒ Valve). a p value was reported significant (<0.05). b Catheter related blood stream infection.
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H. Miyagaki et al. / Clinical Nutrition 31 (2012) 48e52
Statement of authorship Hiromichi Miyagaki M.D. carried out the studies and data analyses, and drafted the manuscript. Kiyokazu Nakajima M.D. conceived of the study, participated in its design and coordination and drafted the manuscript. Joji Hara M.D. participated in this study design, carried out the studies and collection of data. Makoto Yamasaki M.D., Yukinori Kurokawa M.D., Hiroshi Miyata M.D. Shuji Yoshiyuki Fujiwara M.D. Takiguchi M.D. Prof. Masaki Mori and Yuichiro Doki M.D. are participated in provision of significance advice and consultation. Conflict of interest This study was supported financially by Nippon Sherwood Medical Industries Ltd. (Tokyo, Japan). The authors declare no further conflict of interest. Acknowledgements The authors wish to thank all attending doctors and nurses who participated in this study, and also thank all colleagues who advised us in carrying this study. References 1. Merrer J, De Jonghe B, Golliot F, Lefrant JY, Raffy B, Barre E, et al. Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial. Jama 2001;286:700e7. 2. McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123e33. 3. Ayas NT, Norena M, Wong H, Chittock D, Dodek PM. Pneumothorax after insertion of central venous catheters in the intensive care unit: association with month of year and week of month. Qual Saf Health Care 2007;16:252e5. 4. Eisen LA, Narasimhan M, Berger JS, Mayo PH, Rosen MJ, Schneider RF. Mechanical complications of central venous catheters. J Intensive Care Med 2006;21:40e6. 5. Leung TK, Lee CM, Tai CJ, Liang YL, Lin CC. A retrospective study on the longterm placement of peripherally inserted central catheters and the importance of nursing care and education. Cancer Nurs 2011;34:E25e30. 6. Ryder MA. Peripheral access options. Surg Oncol Clin N Am 1995;4:395e427. 7. Smith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg 1998;176:208e11. 8. Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc 1997;72:225e33. 9. Hadaway LC. Major thrombotic and nonthrombotic complications. Loss of patency. J Intraven Nurs 1998;21:S143e60. 10. Skiest DJ, Abbott M, Keiser P. Peripherally inserted central catheters in patients with AIDS are associated with a low infection rate. Clin Infect Dis 2000;30:949e52. 11. Kovacevich DS, Papke LF. Guidelines for the prevention of intravascular catheter-related infections: Centers for Disease Control and Prevention. Nutr Clin Pract 2003;18:95e6.
12. Haider G, Kumar S, Salam B, Masood N, Jamal A, Rasheed YA. Determination of complication rate of PICC lines in oncological patients. J Pak Med Assoc 2009;59:663e7. 13. Cowl CT, Weinstock JV, Al-Jurf A, Ephgrave K, Murray JA, Dillon K. Complications and cost associated with parenteral nutrition delivered to hospitalized patients through either subclavian or peripherally-inserted central catheters. Clin Nutr 2000;19:237e43. 14. King MM, Rasnake MS, Rodriguez RG, Riley NJ, Stamm JA. Peripherally inserted central venous catheter-associated thrombosis: retrospective analysis of clinical risk factors in adult patients. South Med J 2006;99:1073e7. 15. Bonizzoli M, Batacchi S, Cianchi G, Zagli G, Lapi F, Tucci V, et al. Peripherally inserted central venous catheters and central venous catheters related thrombosis in post-critical patients. Intensive Care Med 2011;37:284e9. 16. Mazzola JR, Schott-Baer D, Addy L. Clinical factors associated with the development of phlebitis after insertion of a peripherally inserted central catheter. J Intraven Nurs 1999;22:36e42. 17. Chow LM, Friedman JN, Macarthur C, Restrepo R, Temple M, Chait PG, et al. Peripherally inserted central catheter (PICC) fracture and embolization in the pediatric population. J Pediatr 2003;142:141e4. 18. Kothari D, Gupta S, Tandon N, Mehrotra A. Accidental cut of peripherally inserted central venous catheter. Intensive Care Med 2010;36:2154e5. 19. Maki DG, Botticelli JT, LeRoy ML, Thielke TS. Prospective study of replacing administration sets for intravenous therapy at 48- vs 72-hour intervals. 72 hours is safe and cost-effective. Jama 1987;258:1777e81. 20. Linder LE, Curelaru I, Gustavsson B, Hansson HA, Stenqvist O, Wojciechowski J. Material thrombogenicity in central venous catheterization: a comparison between soft, antebrachial catheters of silicone elastomer and polyurethane. JPEN J Parenter Enteral Nutr 1984;8:399e406. 21. Raad II , Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. Jama 1994;271:1014e6. 22. Timsit JF, Farkas JC, Boyer JM, Martin JB, Misset B, Renaud B, et al. Central vein catheter-related thrombosis in intensive care patients: incidence, risks factors, and relationship with catheter-related sepsis. Chest 1998;114:207e13. 23. Hernandez D, Diaz F, Suria S, Machado M, Lorenzo V, Losada M, et al. Subclavian catheter-related infection is a major risk factor for the late development of subclavian vein stenosis. Nephrol Dial Transplant 1993;8:227e30. 24. Randolph AG, Cook DJ, Gonzales CA, Andrew M. Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials. Bmj 1998;316:969e75. 25. Elliott TS, Curran A. Effects of heparin and chlorbutol on bacterial colonisation of intravascular cannulae in an in vitro model. J Hosp Infect 1989;14:193e200. 26. Hoffer EK, Borsa J, Santulli P, Bloch R, Fontaine AB. Prospective randomized comparison of valved versus nonvalved peripherally inserted central vein catheters. AJR Am J Roentgenol 1999;173:1393e8. 27. Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol 2000;11:837e40. 28. Nifong TP, McDevitt TJ. The effect of catheter to vein ratio on blood flow rates in a simulated model of peripherally inserted central venous catheters. Chest; 2011. 29. Johnson KL, Kendall K, Roberts AD. Surface energy and the contact of Elastic Solids. Proc R Soc Lond Ser A 1971;324:301e13. 30. Prokopovich P, Perni S. Prediction of the frictional behavior of mammalian tissues against biomaterials. Acta Biomater 2010;6:4052e9. 31. Ong CK, Venkatesh SK, Lau GB, Wang SC. Prospective randomized comparative evaluation of proximal valve polyurethane and distal valve silicone peripherally inserted central catheters. J Vasc Interv Radiol 2010;21:1191e6. 32. Hoffer EK, Bloch RD, Borsa JJ, Santulli P, Fontaine AB, Francoeur N. Peripherally inserted central catheters with distal versus proximal valves: prospective randomized trial. J Vasc Interv Radiol 2001;12:1173e7.