section nursing
kontakt 16 (2014) e17–e23
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Original research article
The importance of nursing standards: Elements to create a standard for sheath decannulation according to EBP Ludmila Klemsová a,*, Katarína Žiaková b a b
Ostrava University in Ostrava, Medical Faculty, Department of Nursing and Midwifery, Ostrava, Czech Republic Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Department of Nursing, Martin, Slovakia
article info
abstract
Article history:
Diagnostic coronarography and coronary interventions have become widely accepted pro-
Received 30 August 2013
cedures in patients with ischaemic heart disease, in the acute, chronic, as well as diagnostic
Accepted 18 November 2013
stages. The interventions on coronary arteries are closely connected with diagnostic cathe-
Available online 22 February 2014
terization and deal with stenoses of coronary arteries. The diagnostic and interventional catheters used for the procedure are inserted through the femoral or radial artery. Decan-
Keywords:
nulation of the sheath following the femoral and radial access is an important part of the
Nursing
procedure. This review article analyses the available literary sources, with the aim of
Radial
determining the possibilities of standardization of the specialized nursing care provided
Femoral
for patients requiring decannulation of the sheath from the arteria radialis, or femoralis,
Compression
following left-side coronary catheterization. The presented paper has been drawn up on the
Standard
basis of a review of expert articles presented in freely accessible databases in the period between 2000 and 2012. The nursing standards for decannulation of the sheath obtained from the links to foreign literature often arise from the conclusions of nursing research (EBP). Standards concentrate on the means and length of compression of the arteria femoralis and arteria radialis; furthermore, they specify the compression device for the respective blood drainage area and maintaining the safety and comfort of the patient. Correctly set standards eliminate the rate of complications (haematoma, bleeding), in relation for example to the type of compression applied on the artery, or to nursing staff trained in compression techniques. The nursing standard is an important part of the procedure, contributing to a reduction in complications and an improvement in the patient's comfort, and has an important platform, especially abroad. Significant elements for the creation of standards and defining the correct criteria according to the EBP standard were analyzed from the available sources. # 2014 Faculty of Health and Social Studies of University of South Bohemia in České Budějovice. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
* Corresponding author at: Ostrava University in Ostrava, Medical Faculty, Department of Nursing and Midwifery, Ostrava, Syllabova 19, 703 00 Ostrava, Czech Republic. E-mail address:
[email protected] (L. Klemsová). http://dx.doi.org/10.1016/j.kontakt.2013.11.001 1212-4117/# 2014 Faculty of Health and Social Studies of University of South Bohemia in České Budějovice. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
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Introduction Specialized nursing care (sheath decannulation) following a coronary intervention is mostly performed outside the catheterization lab, and the means of decannulation in various centres differ in accordance with the custom practice of the department, and depending on the implemented management of sheath decannulation, or whether the department uses a standard for the procedure. Variations may be observed, mainly in the person performing the sheath decannulation (physician or nurse), the technique used, and whether compression devices are used. The rate of catheterization and intervention procedures performed via the radial access has increased in recent years, which has resulted in a significant decrease in serious bleeding complications at the puncture site, namely in relation to the arterial access [1,2]. The advancement of techniques and the vascular access used for cardiac catheterization is very important for improvement in the patients' comfort and safety, with a positive effect on the operational efficacy [2]. These facts must be also reflected in the development of special nursing standards concerning sheath decannulation and nursing care following cardiac catheterization. The aim of a nursing standard is to provide a concordance of nursing care during arterial sheath decannulation in patients following cardiac catheterization and the introduction of specific procedures and preferences from the point of view of the nursing personnel, so that the approaches utilized may be unified according to this standard [3]. This means, that the outcome of introducing a standard for sheath decannulation unifies the nursing practice. The aim of the presented review work was to map the importance of the nursing standard for sheath decannulation, with the selection and definition of elements important for the conception of the standard according to the available literature.
specification was defined as follows: radial, femoral, compression devices, time of compression, personnel training and complications.
Results Decannulation of sheaths from arteries is a significant element which may influence the final outcome of cardiac catheterization. The analysis of literary sources provides the basis for stratification of significant elements important for the monitoring of patients following sheath decannulation, and for subsequent incorporation of the elements into the standard. The nursing standard thus becomes an important phenomenon for defining the correct decannulation procedure in terms of safety, comfort and elimination of complications in the patient. The standard is very important not only in departments where the nurses do not possess a full competency for this specialized procedure and work under the supervision of a physician, but especially in departments where the nurse is fully responsible for the procedure. The presented review maps the importance of nursing standards for highly specialized nursing procedure of decannulation (removal) of the sheath (guide wire) from an artery. The analyzed publications use two different terms for specifying the nursing procedure: ‘‘protocol describing the correct nursing procedure’’ and ‘‘standard’’. In this text, we will use the term ‘‘standard’’, as both these terms convey the same meaning, depending on the focus of the source texts. Based upon the review of selected expert articles pertaining to the problems of arterial sheath decannulation following a leftside catheterization, we divided the analyzed texts into two basic groups – for femoral and radial approaches. Furthermore, we analyzed the selected works according to the specified aims and frequency of aims (patient safety, complications, compression device, time of compression, staff expertise, monitoring of vital functions, audit). These aims do not occur in isolation, but in combination with others.
Materials and methods Femoral approach The authors performed a review of expert articles pertaining to the subject matter of the research; the data selected for analysis were obtained from accessible electronic databases: PubMed, Medline, Cochrane, Medscape Nurses, Google Scholar, Blackwell, and ProQuest.
Selection criteria The reviewed expert literature was published between 2000 and 2012; the search was performed in the Czech, Slovak and English languages, using the Boolean operator ‘‘or/and’’, with the entry of the keywords (nursing, radial, femoral, compression, standard). The authors were able to locate eleven works (7 full texts, 4 abstracts). Based upon these eleven literary sources, an analysis of the factors important for the creation of a standard was performed (Table 1). Other sources were selected according to the requirements of our focus, e.g. those which are generally related to the creation, use and significance of a standard, with a special focus on the post-procedural approach in cases of left-side cardiac catheterization. The narrowed
Aim: patient safety, complications, compression device, time of compression (Table 1) The prospective study was performed on a group of one thousand patients following a diagnostic coronarography (via arteria femoralis) and monitored the safety and efficacy of a 90min standard with the aim of shortening the bed-rest period and improving patient comfort. The newly introduced protocol for prospective monitoring set a bed-rest period of 90 min, the earlier procedure required a 120-min bed-rest. Commercially available compression devices were used. One case of minor bleeding was observed in the group of one thousand patients, and a pseudoaneurysm was diagnosed in two patients (one of whom required a blood transfusion); no haemodynamic instability was reported. From the conclusion it becomes apparent that an early mobilization of patients after 90 min performed in accordance with the defined standard is feasible in clinical practice and presents a safe procedure for patients following a diagnostic coronarography via the right femoral artery [3]. Tagney and Lackie and their colleagues concentrated
Table 1 – Analysis of literary sources – map of selection of monitored parameters important for the standard, elements monitored on the basis of EBP. Author, year of publication, title
Femoral approach
Compression device
Time of compression
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
6
5
8
Audit of the standard
+
+
4
Monitoring of vital functions
+
+
+
Complications
+
+
+
Erudition of the staff
+
+
+
Patient safety
8
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Gall et al. (2006), Rapid ambulation after coronary angiography via femoral artery access: a prospective study of 1,000 patients [2] Tagney and Lackie (2005), Bed-rest post-femoral arterial sheath removal – what is safe practice? A clinical audit [4] Klemsová et al. (2010), Časné vyjmutí zavaděče z arteria femoralis registrovanými sestrami po diagnostické koronarografii [5] Schiks et al. (2007), Performance evaluation of arterial femoral sheath removal by registered nurses after PCI [9] Liew et al. (2007), Very low complication rates with a manual, nurse-led protocol for femoral sheath removal following coronary angiography [6] Singleton (2003), Comparing the effects of two types of groin dressing securements on skin integrity, hematoma formation and bleeding after arterial sheath removal [7] Carrington et al. (2009), An accelerated hemostasis protocol following transradial cardiac catheterization is safe and may shorten hospital stay [19] Gonzales et al. (2010), Quality improvement in the catheterization laboratory: redesigning patient flow for improved outcomes [10] Steffenino et al. (2006), Vascular access complications after cardiac catheterisation: a nurse-led quality assurance program [8] Steffenino et al. (2011), Implementation of radial arterial access for cardiac interventions: a strong case for quality assurance protocols by the nursing staff [21] Rathore et al. (2010), A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention [20] Frequency of the monitored items
Radial approach
3
7
1
3
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on monitoring the optimal time required for haemostasis following a puncture of the femoral artery. The authors, with the use of available literature, concentrated on identifying the practice introduced in Great Britain, with the aim of determining whether the period of bed-rest could be shortened without an observed rise in the number of complications, which would enable an increase in the number of procedures performed. The audit tool (standard) was designed for data collection and included the following points: means of haemostasis at the femoral artery, the period of bed-rest necessary following the removal of the guide wire, and all post-procedural complications observed in patients. The average (mean) period of bedrest of 6 h was shortened to 3 h. Shortening the period of bedrest following cardiac catheterization did not significantly influence the rate of complications. These findings resulted in significant changes in the clinical practice and procedures performed according to defined standards, significantly decreasing the period of bed-rest. The procedure should be verified again, due to the increased use of femoral arterial closure devices [4]. Klemsová et al. performed a prospective monitoring of patients following a diagnostic coronarography, with a special focus on the puncture site, finding and analysis of observed complications following the removal of the 4F sheath from the arteria femoralis, using the Compressar mechanical compression device. The authors determined various patient risks: age, obesity and medication (antiaggregant medication: acetylsalicylic acid, heparin, clopidogrel). Furthermore, items of nursing monitoring were specified: pain at the puncture site, subcutaneous resistance, haematoma and its size in centimetres, subjective and objective complaints of the patient. The use of the Compressar mechanical compression device proved beneficial in the clinical practice; it is a device which is safe for the patient and the medical staff, enabling easy handling. The rate of complications observed in the patient file was 2.6%, which, when compared with the literary sources, presents a lower limit of tolerance (2–5%). An early removal of the sheath using a compression device decreases the risk of complications, shortens the hospitalization period and helps to improve patient comfort following coronarography [5]. Liew et al. worked with the hypothesis that it is possible to influence the number of complications by using a nursing standard defining the procedure following the femoral removal of the guiding wire after coronary angiography. The data were collected prospectively, among a group of patients who had undergone a diagnostic coronarography via the arteria femoralis in one interventional centre. The sheaths were removed by trained nurses, with the direct use of manual compression of the femoral artery, in accordance with the defined standard. The prospective study included 516 patients and verified the correctness of the hypothesis, together with the correctly and safely defined standard, with the possibility of its subsequent use in other centres [6]. Singleton studied a project of quality improvement in the clinical practice, by defining a standard for clinical practice following decannulation of the femoral sheath, with the aim of protecting the skin integrity through adjustment of an adequate cover over the puncture site. The main problem was identified by the nursing staff in Midwestern Regional Medical Center, and consisted of impairment of the skin
integrity in the course of treatment of the puncture site. The standard for post-procedural care was revised; furthermore, a scientifically based evaluation of patient care was performed. Significant and EBP based change occurred in the area of use of fixation bands for the treatment of the puncture site (Medipore H), and this change was incorporated into the standard and applied in clinical practice. An important outcome of the project was the fact that clinicians were able to identify problems, and this had a positive impact on patient care; their participation helped to improve the quality of the project and the guideline – standard [7]. A Quality Management programme following a cardiac catheterization led by a nurse and aimed at reducing the rate of vascular complications, was the fundamental goal of the work carried out by Steffenino et al. The aim of their work was to follow complications after cardiac catheterization which were responsible for discomfort in patients; furthermore, prolongation of hospitalization and worsening of the general outcome of the catheterization procedure were also observed. Vascular complications were assessed according to the type of arterial access and the use and non-use of arterial closure devices, as a measure of subsequent quality improvement (over a period of 4 months). Radial access was used in 78 patients (14%), femoral access in 470 patients (83%). A total of 136 closure devices were used in the course of 564 procedures. Haematomas of various sizes were observed in 9.6% of cases. More serious complications (loss of haemoglobin exceeding 2 g, need of blood transfusion or vascular revision) were observed in 1.2% of cases none of which was observed in patients following the radial approach: all belonged to the femoral access group (0.4% in the diagnostic coronarography group: 2.4% in the coronary intervention group. The activated coagulation time observed in cases of complications (n = 40) was 309 83; in the group of non-complicated procedures using femoral access (n = 172), the activated coagulation time was 271 71 (with P = 0.004). The closure devices were identical. The number of complications in the group monitored within the quality improvement programme was lower than cited in the literature used for comparing the results. Intensive anticoagulation was connected with an increased number of complications, regardless of the closure device. The outcome of the project was the recommendation to use the radial approach whenever possible, and to use the transfemoral approach with a less-aggressive anticoagulation therapy (this recommendation will be further tested) [8].
Aim: expertise of the staff Schiks et al. emphasize the need for introducing an educational programme aimed at sheath decannulation for registered nurses, in order to meet the standard. The educational programme included training of registered nurses in the techniques of sheath removal and a direct observation of selected non-complicated patients following a cardiac catheterization. The observations were recorded in a specifically defined checklist, including 10 elements and 65 items, which were assessed. In order to obtain an optimal score, the registered nurses were required to reach at least 80–89% success rate with sheath decannulation procedures. Taking into consideration the fact, that the standard for an excellent procedure is 90% and above, it may be possible to reach this
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goal with a repeated training (once a year) and monitoring of the skills of nurses in the course of this specialized procedure. Further research must concentrate on validating the tool for measuring the standard of success [9]. Also the results presented by Gonzales et al. brought significant findings, leading to a decrease in the rate of vascular complications following a removal of the sheath from the arteria femoralis. Unified processes (standards) have been defined based upon their conclusions, as well as other expert literature and the monitoring of complications in clinical practice. The factors, which contributed to decreasing the rate of complications, included a newly established team of catheterization lab nurses specially trained in sheath decannulation techniques, training provided for the staff at clinical departments and change in the practice of application of pressure bandages, so that the puncture site remained visible and freely accessible [10]. Based upon the prospective monitoring of patients following coronarography procedure via arteria femoralis, authors Klemsová et al. prepared a certified course for registered nurses entitled ‘‘Special nursing care provided for patients following diagnostic coronarography’’ [5]. The Ministry of Health of the Czech Republic has approved the course for use in practice.
Radial access Aim: patient safety, complications, compression device, time of compression (Table 1) The number of patients catheterized and undergoing intervention via the radial artery has been increasing in the past 10 years, with a corresponding increase in the number of centres where the radial approach becomes, or has become, the access of first choice. Apart from coronary catheterizations and interventions, this approach may also be successfully used for non-coronary procedures [11]. Trans-radial approaches for cardiac catheterization are more frequently used in Europe and Asia, only 1.32% of approaches via arteria radialis were performed in the USA between 2004 and 2007 [12]. The number of approaches via arteria radialis in the Czech Republic has increased dramatically, e.g. the rate was 5% in 2005, reaching 43.3% in 2010 [13]. The data from the most recent period have not been analyzed yet. The nursing care techniques performed in patients following cardiac catheterization must adapt to these trends in relation to the puncture site. The compression of the puncture site following the radial approach is easier than in cases of the femoral approach, also due to the compression devices available, such as Hemostop (Zoom Co. Medic), Safeguard (Datascope), Radistop (Radi Medical System), RadStat (MeritMedical) and TR Band (Terumo). Another reason is that this approach is also preferred by the patients, who may be examined at out-patient departments, and the work load of the staff is also reduced, together with the period of necessary hospitalization and the overall costs of the treatment [14–17]. Jolly et al. state in their study, that the radial approach decreased the risk of significant bleeding by 73% when compared to the femoral approach; a shortening of the hospitalization by 0.4 day has also been observed [18]. Due to the absence of a standard for application of haemostatic devices following arterial sheath decannulation,
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Carrington et al. performed a study, the aim of which was to compare the length of compression of the arteria radialis using the TR Band (compression device). The main question was, whether the compression time may be shortened to 1 h, in contrast to the manufacturer's recommended time of 2 h. A total of one hundred patients following coronary catheterization were enrolled into this prospective study. The average age of the study subjects was 62 years, with an average BMI of 29.51% of the patients suffered from hypertension and 9% of patients were receiving anticoagulation treatment with warfarin. There were no differences observed in all prespecified possible complications. The compression with TR Band for 60 min in patients following transradial diagnostic coronary catheterization seems to be safe, while respecting the standard, which shortens the total time of patient care and enables an early discharge [19]. The aim of the comparative randomized clinical trial performed by Rathore et al. was to perform a comparison of compression devices positioned at the radial artery (TR Band, Radistop). A total of 790 patients were randomized into two groups (receiving either TR Band or Radiostop in order to achieve haemostasis). The monitored factors included the following: tolerance of the compression device by the patient, local vascular complications and the time required to achieve haemostasis. The results show, that both Radiostop and TR Band are safe and effective devices for achieving haemostasis following radial artery access. More patients felt a certain discomfort with Radiostop, and the use of TR Band was associated with longer times required to achieve haemostasis [20]. Stefennino et al. present a strong argument from the nursing staff point of view, i.e. monitoring 973 patients undergoing coronary catheterization via arteria radialis with the use of bandage (inflatable device) in order to achieve haemostasis. The inflation volume and time of applying the bandage (A = 175 patients, B = 297 patients, C = 501 patients) were assessed. No significant loss of pulsation was observed in the groups, no haematoma of any size was observed. The assessment of pulsation following an inflation bandage: A = 81.3%, B = 90.9%, C = 92.2%, (P < 0.001), without any discomfort: A = 44.2%, B = 75.1%, C = 89.3%, (P < 0.001). The follow up stage was performed in 956 patients, these did not present with any vascular complications. Loss of pulsation in the radial artery was observed in 0.6% of patients; in group C, the loss of pulsation was observed in 5% of the patients (20 h following haemostasis). The Barbeau test (i.e. plethysmography and pulse oximetry) was positive in 26.5% of patients. The reason was a lower body weight, lower values of systolic blood pressure in the course of inflation during haemostasis and a higher inflation volume, haematoma and discomfort were also observed more often. The nursing quality management programme helped to reduce minor vascular complications and improved the comfort of patients following the radial access. Early radial occlusions are quite common, but reversible [21]. Although the radial artery occlusion following cardiac catheterization usually presents a totally asymptomatic complication of the procedure, it does not enable performance of other types of catheterization or interventions with the same access. On the contrary, non-occlusive compression of
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the artery for the minimum possible time possesses a significant importance for its reduction. Excessive pressure applied at the artery and an overlong compression time result in a decrease in bleeding complications; however they are also responsible for a higher occurrence of occlusion of the artery following the procedure. The management of perfusion haemostasis following transradial catheterization is possible only in close cooperation with physicians and nurses, whose role is irreplaceable in the routine operation of the clinical department [22].
Discussion The analysis of the expert literature has led us to the conclusion that femoral artery access for catheterizations prevails. This was caused by the selection criteria for the expert literature, the earliest selection date was defined as the year 2000, which meant that the literary sources then included articles from an earlier time when the femoral approach was preferred. Another significant factor is the inclusion of foreign literary data, where the femoral approach presents as the firstchoice treatment. The situation in the Czech Republic is rather different, according to data from the central ÚZIS database. The radial access has been used in more than 40% of procedures since 2010. The safety and comfort of the patient are very closely related together and belong among the most monitored goals in our set of publications. Patient safety is mentioned as an aim in 8 cases, and complications in 7 cases of the analyzed file. The use and type of compression devices in close relation to the time of compression, are other monitored parameters; the type of compression device used was assessed in six publications, the time of compression in five of them. The aims concerning the expertise of the staff and audit of the standard was mentioned three times, monitoring of physiological functions in the course of decannulation was listed once. According to the literary sources analyzed, it is apparent that the finalization of cardiac catheterization is connected with sheath decannulation, and thus becomes a significant phenomenon in the occurrence of complications after the procedure. As presented in the work of Liew et al., the correct nursing procedure, in accordance with a standard, may influence the incidence of complications [6]. Also the means of accomplishment and defining of decannulation devices is a significant element of the nursing standard and contribute to quality improvement in the clinical practice, as presented by Singleton [7]. Tagney et al. performed a survey among nurses, monitoring the implementation, compliance with and optimal setting of standards in the clinical practice in Great Britain. The authors were able to confirm, with a defined auditing tool, one of the factors important for clinical practice, i.e. shortening of the period of bed-rest from 6 to 3 h (necessary immobilization following sheath decannulation), which is a significant improvement in patient comfort [4]. The expertise of nurses is a key element for fulfilment of the standard and the nursing procedures; the most appropriate seems to be an educational programme for sheath decannulation, as presented by Schiks et al. [9]. Also the team of Klemsová et al. arrived at a similar conclusion, when, based upon the acquired experience and
prospective monitoring of the patient, the authors defined a proposal for establishing a certified course for registered nurses, entitled ‘‘Special nursing care provided for patients following diagnostic coronarography’’ [5]. Monitoring and reduction of the incidence of vascular complications following a sheath decannulation, based upon individual standards or a quality management programme led by a nurse, are significant factors in a specialized nursing procedure [10,21]. Expert nursing publications, describing advancements in arterial approaches and sheath decannulation are proof that the nursing standards need to be adjusted constantly, based upon tendencies to minimize risks and complications and prioritize patient comfort following a catheterization procedure. The systematic review performed by the authors confirmed a decrease of risk of bleeding due to the radial approach by 73% [18]. The compression of arteria radialis is easier also due to the use of compression devices. Rathore et al. [20] compared two different compression devices – TR Band and Radistop, and confirmed their efficacy and safety for achieving compression. A greater feeling of discomfort was observed in the group of patients with Radiostop, and the use of TR Band required a longer period of applying the device on the artery [20]. The quality management programme (reduction of complications), managed by a nurse is closely related to the quality of the standard, which is a strong argument in the defined procedures from the nursing staff point of view, as mentioned by Stefennino et al. [21]. The literary sources included in our review are presented in the form of a table, which enabled us to create a ‘‘map’’ of significant elements. Most often, these include the defined aims of the reviewed works. The elements are supported with expert EBP works, which may present a lead for a correct and complex definition of the standard for sheath decannulation, or they may be used as an auditing or research tool. These elements may be considered valid, as they are based upon nursing research activities, randomized trial or meta-analyses, which underlines the significance of EBP. The significance of EBP is confirmed also in the work of Zeleníková et al., in their thesis that evidence-based nursing is a process of clinical decision-making of nurses through the use of the most accessible research results, clinical experience and patient preferences in the context of available means. The EBP presents a very hard, but nevertheless beneficial measurement tool for the standard [23].
Conclusion The nursing standard is a very important phenomenon for defining the correct procedure of sheath decannulation, as regards safety, comfort and elimination of complications. Standards play an important role, especially abroad, not only within one department, but also on the nation-wide level of the whole of Great Britain, with the aim of performing specialized nursing procedures in a uniform way, in accordance with individual standards. The ‘‘map’’ of elements, which are significant for the standard, may be used as a universal tool for capturing the elements in other areas of nursing practice, based upon EBP. According to Gurková and Žiaková, the implementation of EBP principles into clinical
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practice depends mainly on the availability of adequate research in the given area, the skills of nurses in searching for sources of evidence and their critical review [24]. The standards must be always adjusted according to the conditions, conventions, types of compression devices used at the respective department, and quantification of the quality of nursing care, based upon measurable indicators. The quality indicators are measurable criteria, which, when compared with a certain standard, policy or a requirement, show the degree of compliance with these regulations [25]. This thesis also emphasises the importance of standards, not only in the area of arterial sheath decannulation, but on the general level of nursing as well. Our file of reviewed expert literature includes only one expert publication of Czech authors dealing with this topic. This certainly does not point towards a lack of expertise, incompetence, or malfunction of nursing care in the areas of nursing procedures, which include also the decannulation of arterial sheaths. The system of management of specialized nursing care at catheterization labs in the Czech Republic, including the expertise of nurses, is a subject of further research performed by the authors.
Conflict of interest No conflict of interest.
references
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