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Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial

BACKGROUND: Peripherally inserted central catheters (PICCs) are now widely used in modern medicine, and associated complications have also increased. Central line-associated bloodstream infection (CLABSI) is the most serious complication because it can cause extended hospital stays and increase cost...

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Autores principales: Kwon, Yohan, Kim, Eung Tae, Cho, Soo Buem, Lee, Jae Hwan, Shim, Dong Jae
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9479292/
https://www.ncbi.nlm.nih.gov/pubmed/36109819
http://dx.doi.org/10.1186/s13063-022-06682-2
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author Kwon, Yohan
Kim, Eung Tae
Cho, Soo Buem
Lee, Jae Hwan
Shim, Dong Jae
author_facet Kwon, Yohan
Kim, Eung Tae
Cho, Soo Buem
Lee, Jae Hwan
Shim, Dong Jae
author_sort Kwon, Yohan
collection PubMed
description BACKGROUND: Peripherally inserted central catheters (PICCs) are now widely used in modern medicine, and associated complications have also increased. Central line-associated bloodstream infection (CLABSI) is the most serious complication because it can cause extended hospital stays and increase costs. Furthermore, it can contribute to dire consequences for critically ill patients. Subcutaneous tunnelling for central venous catheters is an accepted method to reduce the risk of CLABSI. However, it is not generally adopted for PICC placement in most hospitals because its safety and efficacy have not been thoroughly evaluated. METHODS: In this multi-institutional, prospective, non-blinded pragmatic randomized controlled trial, 1694 patients treated at five referral hospitals will be assigned to one of two parallel arms (conventional and tunnelled PICC groups) using computer-generated stratified randomization. The conventional group will undergo PICC placement by routine practice. In the tunnelled PICC (tPICC) group, additional subcutaneous tunnelling will be applied. Patients will be followed until PICC removal or the end of this study. The primary endpoint is whether subcutaneous tunnelling reduced the rate of CLABSI compared to the conventional method. The secondary endpoints are technical success rates, complications including exit-site bleeding or infection, and the procedure time between the groups. DISCUSSION: Subcutaneous tunnelling is a widely used method to reduce catheter-associated infection. However, it has not been thoroughly applied for PICC. A randomized trial is needed to objectively assess the effects of the subcutaneous tunnel in PICC placement. This TUNNEL-PICC trial will provide evidence for the effectiveness of subcutaneous tunnelling in decreasing the risk of CLABSI. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0005521
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spelling pubmed-94792922022-09-17 Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial Kwon, Yohan Kim, Eung Tae Cho, Soo Buem Lee, Jae Hwan Shim, Dong Jae Trials Study Protocol BACKGROUND: Peripherally inserted central catheters (PICCs) are now widely used in modern medicine, and associated complications have also increased. Central line-associated bloodstream infection (CLABSI) is the most serious complication because it can cause extended hospital stays and increase costs. Furthermore, it can contribute to dire consequences for critically ill patients. Subcutaneous tunnelling for central venous catheters is an accepted method to reduce the risk of CLABSI. However, it is not generally adopted for PICC placement in most hospitals because its safety and efficacy have not been thoroughly evaluated. METHODS: In this multi-institutional, prospective, non-blinded pragmatic randomized controlled trial, 1694 patients treated at five referral hospitals will be assigned to one of two parallel arms (conventional and tunnelled PICC groups) using computer-generated stratified randomization. The conventional group will undergo PICC placement by routine practice. In the tunnelled PICC (tPICC) group, additional subcutaneous tunnelling will be applied. Patients will be followed until PICC removal or the end of this study. The primary endpoint is whether subcutaneous tunnelling reduced the rate of CLABSI compared to the conventional method. The secondary endpoints are technical success rates, complications including exit-site bleeding or infection, and the procedure time between the groups. DISCUSSION: Subcutaneous tunnelling is a widely used method to reduce catheter-associated infection. However, it has not been thoroughly applied for PICC. A randomized trial is needed to objectively assess the effects of the subcutaneous tunnel in PICC placement. This TUNNEL-PICC trial will provide evidence for the effectiveness of subcutaneous tunnelling in decreasing the risk of CLABSI. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0005521 BioMed Central 2022-09-15 /pmc/articles/PMC9479292/ /pubmed/36109819 http://dx.doi.org/10.1186/s13063-022-06682-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Kwon, Yohan
Kim, Eung Tae
Cho, Soo Buem
Lee, Jae Hwan
Shim, Dong Jae
Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title_full Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title_fullStr Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title_full_unstemmed Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title_short Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
title_sort subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (tunnel-picc): a study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9479292/
https://www.ncbi.nlm.nih.gov/pubmed/36109819
http://dx.doi.org/10.1186/s13063-022-06682-2
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