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A Trial Analysis of Umbilical Venous Catheters: The Long and Short of It
RESEARCH CORNER
A Trial Analysis of Umbilical Venous Catheters: The Long and Short of It By Holly Mincey, RN, BSN, Column Editor fter much investigating and searching for the perfect research trial related to the umbilical venous catheter (UVC), many issues came to light. First and foremost, the amount of literature related to the UVC line is vast and endless. One may search, study, and read for days on this one particular medical intervention. This is a result of UVC placement and use within our neonatal intensive care units (NICUs) for over 25 years. One may surmise that the use of such a tool has enabled our NICU population to efficiently receive medications and fluids with greater benefit than risk. This has also been the impetus for research to provide the evidence for optimal use of the UVC while limiting potential, harmful side-effects. As one reviews the literature, it is apparent that the placement and use of an UVC are not without complications. A continual theme arises within most of the recent research connected to the UVC. The profound complication of UVC line infection was a continuum within most of the literature surveyed. This complication has been related to placement, proper technique of access, management of line, catheter exit site and hub handling, and length of placement to name a few. Although these are all important issues related to infection, the trial in review is one of great interest and debate. The optimal time frame to maintain an UVC in place and its relationship to infection are reviewed in this trial.1,2 What is the long and short of it? Guidelines and literary recommendations range from conservative to very liberal and include distant and recent literature. O’Grady et al3 in 2002 recommends, bOptimally, umbilical artery catheters should not be left in place greater than five daysQ (p.51). Loisel et al4 in 1996, stated, bAn umbilical venous catheter used during the first two weeks of life is relatively safeQ (p. 463). The Centers for Disease Control and Prevention5 recommend that UVC placement be maintained for up to 14 days to prevent further risk factors (2002, http://www.cdc.gov/). The trial bA randomized trial comparing long-term and short-term use of umbilical venous catheters in premature infants with birth weights of less than 1251 gramsQ6 compares infection rates between two distinct groups of premature infants weighing less than 1251 grams at birth who have a UVC placed. The primary hypothesis is that infants with long-term UVC placement have fewer infections.
A
From the Division of Neonatology, Clinical Research, University of Cincinnati, OH; Cincinnati Children’s Hospital Medical Center, OH; and Good Samaritan Hospital, Cincinnati, OH. Address correspondences to Holly Mincey, RN, BSN, 8223 Alpine Aster Court, Liberty Township, OH 45044, USA. n 2006 Elsevier Inc. All rights reserved. 1527-3369/06/0604-0166$10.00/0 doi:10.1053/j.nainr.2006.09.009
Newborn and Infant Nursing Reviews, Vol 6, No 4 (December), 2006: pp 241-242
241
242
Holly Mincey
The trial was implemented in a tertiary, referral NICU with 52-bed availability in New York. All infants less than or equal to 1250 grams at birth and requiring an UVC, either single or double lumen, were eligible to participate; this included infants weighing less than 500 grams or less than 24 weeks gestation with the attending neonatologist approval. Exclusion criteria included known diagnosis of gastrointestinal abnormalities or congenital heart diseases. The hospital Institutional Review Board approved of the trial conduction, and parental consent was obtained before infant participation during the first 7 to 10 days of life. Trial conduction included a randomized assignment to the long-term UVC or short-term UVC group. There was an envelope system in place in which a clinical team member obtained and opened a sealed envelope that identified in which group the infant would be placed. The group assignment was not masked. The short-term group maintained UVC placement up to 10 days. If further intravenous access was necessary, a percutaneous central venous catheter (PCVC) was placed. The length of time the PCVC was in place was determined by the clinical team and may be replaced at any time if necessary. The long-term group maintained the UVC in place for up to 28 days if necessary; otherwise, it was removed. A PCVC was placed if further intravenous access was necessary after 28 days. An echocardiogram was performed at defined time points within the trial, and data were collected to determine the presence of structural heart disease as well as catheter placement or presence of pericardial effusions. At the time a septic workup was performed, a simultaneous quantitative peripheral and catheter blood culture was performed. A specific laboratory process was conducted to maintain cohesive laboratory results in the event of a potential positive culture. The trial defined infection as symptoms including temperature instability, increased ventilator settings, increased apnea or bradycardia or desaturations, feeding intolerance, or blood pressure instability in combination with a single positive blood culture for defined definite pathogens. This definition also included multiple, greater than two within 48 hours, positive cultures from the catheter tip, cerebral spinal fluid or urine in combination with at least one positive blood culture. The end point of the trial was one positive blood culture while the catheter was in place. Once a defined infection had occurred, the infant completed the trial, and data collection ceased. At the time the catheter was clinically ordered to be discontinued, the infant was defined as experiencing no catheter-related infection. The primary outcome was the
time from birth until the occurrence of a catheter-related infection up to 28 days of catheter placement. There were 106 infants enrolled in the short-term group and 104 infants enrolled in the long-term group. Similarities exist within sex, race, and mean birth weight. The maintenance and care for each catheter were standardized. Catheter placement was verified by chest and abdominal x-ray. Although this trial was well conducted, randomized, and clearly defined, the results reported the opposite conclusion the author predicted. The defined time to catheter-related infection did not show a significant difference between the two groups. The trial reported a 7% absolute difference in infection rates between these two groups. This was not statistically significant, yet within a larger trial, the results may be otherwise. The results obtained are of value in that when necessity presents the need for long-term UVC use, this may be used without a great fear of significant risk of increased infection rates. These results may indicate adherence to proper protocol instituted in the practice of UVC maintenance and use. This trial verifies that one may maintain UVC placement for a longer period without increased risk of infection, yet larger trials need to verify this issue. The long and the short of it identifies the potential need for further investigation and research if practitioners intend on long-term placement of the UVC to be implemented as standard practice.
References 1. Apostolopoulo E, Lambridou M, Lambadaridis I. Nosocomial bloodstream infections in a neonatal intensive care unit. Br J Nurs. 2004; 13:806 - 812. 2. Cartwright DW. Central venous lines in neonates: a study of 2186 catheters, Archives of disease in childhood. Fetal Neonatal Ed. 2004;89: F504-F508. 3. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Pediatrics. 2002; 110:51. 4. Loisel DB, Smith MM, MacDonald MG, Martin GR. Intravenous access in newborn infants: impact of extended umbilical venous catheter use on requirement for peripheral venous lines. J Perinatology. 1996;16: 461 - 466. 5. Centers for Disease Control and Prevention. Guidelines for prevention of intravascular catheter-related infections. MMWR Morb Mortal Wkly Rep. 2002;51:1 - 32 [Website http://www.cdc.gov/]. 6. Butler-Ohara M, Buzzard CJ, MacDermott MP, DiGrazio W, D’Angio CT. A randomized trial comparing long-term and short-term use of umbilical venous catheters in premature infants with birth weights of less than 1251 grams. Pediatrics. 2006;118:e25-e35.
A Trial Analysis of Umbilical Venous Catheters: The Long and Short of It By Holly Mincey, RN, BSN, Column Editor fter much investigating and searching for the perfect research trial related to the umbilical venous catheter (UVC), many issues came to light. First and foremost, the amount of literature related to the UVC line is vast and endless. One may search, study, and read for days on this one particular medical intervention. This is a result of UVC placement and use within our neonatal intensive care units (NICUs) for over 25 years. One may surmise that the use of such a tool has enabled our NICU population to efficiently receive medications and fluids with greater benefit than risk. This has also been the impetus for research to provide the evidence for optimal use of the UVC while limiting potential, harmful side-effects. As one reviews the literature, it is apparent that the placement and use of an UVC are not without complications. A continual theme arises within most of the recent research connected to the UVC. The profound complication of UVC line infection was a continuum within most of the literature surveyed. This complication has been related to placement, proper technique of access, management of line, catheter exit site and hub handling, and length of placement to name a few. Although these are all important issues related to infection, the trial in review is one of great interest and debate. The optimal time frame to maintain an UVC in place and its relationship to infection are reviewed in this trial.1,2 What is the long and short of it? Guidelines and literary recommendations range from conservative to very liberal and include distant and recent literature. O’Grady et al3 in 2002 recommends, bOptimally, umbilical artery catheters should not be left in place greater than five daysQ (p.51). Loisel et al4 in 1996, stated, bAn umbilical venous catheter used during the first two weeks of life is relatively safeQ (p. 463). The Centers for Disease Control and Prevention5 recommend that UVC placement be maintained for up to 14 days to prevent further risk factors (2002, http://www.cdc.gov/). The trial bA randomized trial comparing long-term and short-term use of umbilical venous catheters in premature infants with birth weights of less than 1251 gramsQ6 compares infection rates between two distinct groups of premature infants weighing less than 1251 grams at birth who have a UVC placed. The primary hypothesis is that infants with long-term UVC placement have fewer infections.
A
From the Division of Neonatology, Clinical Research, University of Cincinnati, OH; Cincinnati Children’s Hospital Medical Center, OH; and Good Samaritan Hospital, Cincinnati, OH. Address correspondences to Holly Mincey, RN, BSN, 8223 Alpine Aster Court, Liberty Township, OH 45044, USA. n 2006 Elsevier Inc. All rights reserved. 1527-3369/06/0604-0166$10.00/0 doi:10.1053/j.nainr.2006.09.009
Newborn and Infant Nursing Reviews, Vol 6, No 4 (December), 2006: pp 241-242
241
242
Holly Mincey
The trial was implemented in a tertiary, referral NICU with 52-bed availability in New York. All infants less than or equal to 1250 grams at birth and requiring an UVC, either single or double lumen, were eligible to participate; this included infants weighing less than 500 grams or less than 24 weeks gestation with the attending neonatologist approval. Exclusion criteria included known diagnosis of gastrointestinal abnormalities or congenital heart diseases. The hospital Institutional Review Board approved of the trial conduction, and parental consent was obtained before infant participation during the first 7 to 10 days of life. Trial conduction included a randomized assignment to the long-term UVC or short-term UVC group. There was an envelope system in place in which a clinical team member obtained and opened a sealed envelope that identified in which group the infant would be placed. The group assignment was not masked. The short-term group maintained UVC placement up to 10 days. If further intravenous access was necessary, a percutaneous central venous catheter (PCVC) was placed. The length of time the PCVC was in place was determined by the clinical team and may be replaced at any time if necessary. The long-term group maintained the UVC in place for up to 28 days if necessary; otherwise, it was removed. A PCVC was placed if further intravenous access was necessary after 28 days. An echocardiogram was performed at defined time points within the trial, and data were collected to determine the presence of structural heart disease as well as catheter placement or presence of pericardial effusions. At the time a septic workup was performed, a simultaneous quantitative peripheral and catheter blood culture was performed. A specific laboratory process was conducted to maintain cohesive laboratory results in the event of a potential positive culture. The trial defined infection as symptoms including temperature instability, increased ventilator settings, increased apnea or bradycardia or desaturations, feeding intolerance, or blood pressure instability in combination with a single positive blood culture for defined definite pathogens. This definition also included multiple, greater than two within 48 hours, positive cultures from the catheter tip, cerebral spinal fluid or urine in combination with at least one positive blood culture. The end point of the trial was one positive blood culture while the catheter was in place. Once a defined infection had occurred, the infant completed the trial, and data collection ceased. At the time the catheter was clinically ordered to be discontinued, the infant was defined as experiencing no catheter-related infection. The primary outcome was the
time from birth until the occurrence of a catheter-related infection up to 28 days of catheter placement. There were 106 infants enrolled in the short-term group and 104 infants enrolled in the long-term group. Similarities exist within sex, race, and mean birth weight. The maintenance and care for each catheter were standardized. Catheter placement was verified by chest and abdominal x-ray. Although this trial was well conducted, randomized, and clearly defined, the results reported the opposite conclusion the author predicted. The defined time to catheter-related infection did not show a significant difference between the two groups. The trial reported a 7% absolute difference in infection rates between these two groups. This was not statistically significant, yet within a larger trial, the results may be otherwise. The results obtained are of value in that when necessity presents the need for long-term UVC use, this may be used without a great fear of significant risk of increased infection rates. These results may indicate adherence to proper protocol instituted in the practice of UVC maintenance and use. This trial verifies that one may maintain UVC placement for a longer period without increased risk of infection, yet larger trials need to verify this issue. The long and the short of it identifies the potential need for further investigation and research if practitioners intend on long-term placement of the UVC to be implemented as standard practice.
References 1. Apostolopoulo E, Lambridou M, Lambadaridis I. Nosocomial bloodstream infections in a neonatal intensive care unit. Br J Nurs. 2004; 13:806 - 812. 2. Cartwright DW. Central venous lines in neonates: a study of 2186 catheters, Archives of disease in childhood. Fetal Neonatal Ed. 2004;89: F504-F508. 3. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Pediatrics. 2002; 110:51. 4. Loisel DB, Smith MM, MacDonald MG, Martin GR. Intravenous access in newborn infants: impact of extended umbilical venous catheter use on requirement for peripheral venous lines. J Perinatology. 1996;16: 461 - 466. 5. Centers for Disease Control and Prevention. Guidelines for prevention of intravascular catheter-related infections. MMWR Morb Mortal Wkly Rep. 2002;51:1 - 32 [Website http://www.cdc.gov/]. 6. Butler-Ohara M, Buzzard CJ, MacDermott MP, DiGrazio W, D’Angio CT. A randomized trial comparing long-term and short-term use of umbilical venous catheters in premature infants with birth weights of less than 1251 grams. Pediatrics. 2006;118:e25-e35.