Eung Tae Kim MD , Jae Hwan Lee MD , Dong Jae Shim MD , Yohan Kwon MD , Soo Buem Cho MD , Ki Jun Kim MD , Doyoung Kim MD , Jinoo Kim MD , Eu Suk Kim MD , Hoyong Jun MD , Youn Jeong Kim MD , Jinyeong Kim MD , Eun Jin Kim MD , Chung-Jong Kim MD , Kang-Il Jun MD , Myoung Jin Shin RN , Chang Jin Yoon MD , Seungjae Lee PhD , Soon-Young Song MD , Je Hwan Won MD
{"title":"住院病人皮下隧道植入外周置入中心导管与传统植入外周置入中心导管的比较（TUNNEL-PICC）：一项多中心、开放标签、随机对照试验。","authors":"Eung Tae Kim MD , Jae Hwan Lee MD , Dong Jae Shim MD , Yohan Kwon MD , Soo Buem Cho MD , Ki Jun Kim MD , Doyoung Kim MD , Jinoo Kim MD , Eu Suk Kim MD , Hoyong Jun MD , Youn Jeong Kim MD , Jinyeong Kim MD , Eun Jin Kim MD , Chung-Jong Kim MD , Kang-Il Jun MD , Myoung Jin Shin RN , Chang Jin Yoon MD , Seungjae Lee PhD , Soon-Young Song MD , Je Hwan Won MD","doi":"10.1016/j.jhin.2024.10.008","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>We aimed to evaluate whether subcutaneous tunneling in peripherally inserted central catheters (PICC) placement could reduce the occurrence of central-line associated blood stream infection (CLABSI).</div></div><div><h3>Methods</h3><div>We conducted an open-label, multicentre, randomized, controlled trial in five tertiary hospitals. Adult hospitalized patients requiring a PICC were randomized in a one-to-one ratio to conventional (cPICC) or tunneled PICC (tPICC) arms using a centralized web-based computer-generated stratified randomization. CLABSI rates between groups were compared in a modified intention-to-treat population. Safety including the incidence of exit-site infection or hemorrhage-associated catheter removal were also compared. This trial was registered with Clinical Research Information Service of Republic of Korea (KCT0005521).</div></div><div><h3>Results</h3><div>From November 2020 to March 2023, 1,324 participants were enrolled and randomly assigned to tPICC (<em>n</em>=662) and cPICC (<em>n</em>=662). This study was terminated early due to the cohort CLABSI rate being lower than estimated, therefore, the original sample size of 1,694 would render the study underpowered to detect a difference in CLABSI rates. In the tPICC, CLABSI occurred in 13 of 651 participants over 11,071 catheter-days (1.2/1,000 catheter-days), compared with 20 among 650 patients with cPICC over 11,141 catheter-days (1.8/1,000 catheter-days, rate ratio 0.65, 95% CI 0.30–1.38, <em>p</em>=0.30). The incidence of exit-site infection (29 tPICC, 36 cPICC, <em>p</em>=0.5) and hemorrhage-associated catheter removal (11 tPICC, 11 cPICC, <em>p</em>=0.99) was not different between both groups.</div></div><div><h3>Conclusion</h3><div>Due to insufficient sample size, this study could not demonstrate a statistically significant CLABSI risk reduction in the tPICC group compared to the cPICC group. Both groups had similar rates of exit site infection and bleeding.</div></div>","PeriodicalId":54806,"journal":{"name":"Journal of Hospital Infection","volume":"155 ","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Subcutaneous tunneling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a multicentre, open-label, randomized, controlled trial\",\"authors\":\"Eung Tae Kim MD , Jae Hwan Lee MD , Dong Jae Shim MD , Yohan Kwon MD , Soo Buem Cho MD , Ki Jun Kim MD , Doyoung Kim MD , Jinoo Kim MD , Eu Suk Kim MD , Hoyong Jun MD , Youn Jeong Kim MD , Jinyeong Kim MD , Eun Jin Kim MD , Chung-Jong Kim MD , Kang-Il Jun MD , Myoung Jin Shin RN , Chang Jin Yoon MD , Seungjae Lee PhD , Soon-Young Song MD , Je Hwan Won MD\",\"doi\":\"10.1016/j.jhin.2024.10.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>We aimed to evaluate whether subcutaneous tunneling in peripherally inserted central catheters (PICC) placement could reduce the occurrence of central-line associated blood stream infection (CLABSI).</div></div><div><h3>Methods</h3><div>We conducted an open-label, multicentre, randomized, controlled trial in five tertiary hospitals. Adult hospitalized patients requiring a PICC were randomized in a one-to-one ratio to conventional (cPICC) or tunneled PICC (tPICC) arms using a centralized web-based computer-generated stratified randomization. CLABSI rates between groups were compared in a modified intention-to-treat population. Safety including the incidence of exit-site infection or hemorrhage-associated catheter removal were also compared. This trial was registered with Clinical Research Information Service of Republic of Korea (KCT0005521).</div></div><div><h3>Results</h3><div>From November 2020 to March 2023, 1,324 participants were enrolled and randomly assigned to tPICC (<em>n</em>=662) and cPICC (<em>n</em>=662). This study was terminated early due to the cohort CLABSI rate being lower than estimated, therefore, the original sample size of 1,694 would render the study underpowered to detect a difference in CLABSI rates. In the tPICC, CLABSI occurred in 13 of 651 participants over 11,071 catheter-days (1.2/1,000 catheter-days), compared with 20 among 650 patients with cPICC over 11,141 catheter-days (1.8/1,000 catheter-days, rate ratio 0.65, 95% CI 0.30–1.38, <em>p</em>=0.30). The incidence of exit-site infection (29 tPICC, 36 cPICC, <em>p</em>=0.5) and hemorrhage-associated catheter removal (11 tPICC, 11 cPICC, <em>p</em>=0.99) was not different between both groups.</div></div><div><h3>Conclusion</h3><div>Due to insufficient sample size, this study could not demonstrate a statistically significant CLABSI risk reduction in the tPICC group compared to the cPICC group. Both groups had similar rates of exit site infection and bleeding.</div></div>\",\"PeriodicalId\":54806,\"journal\":{\"name\":\"Journal of Hospital Infection\",\"volume\":\"155 \",\"pages\":\"\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-10-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Hospital Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0195670124003566\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Hospital Infection","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0195670124003566","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Subcutaneous tunneling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a multicentre, open-label, randomized, controlled trial
Objective
We aimed to evaluate whether subcutaneous tunneling in peripherally inserted central catheters (PICC) placement could reduce the occurrence of central-line associated blood stream infection (CLABSI).
Methods
We conducted an open-label, multicentre, randomized, controlled trial in five tertiary hospitals. Adult hospitalized patients requiring a PICC were randomized in a one-to-one ratio to conventional (cPICC) or tunneled PICC (tPICC) arms using a centralized web-based computer-generated stratified randomization. CLABSI rates between groups were compared in a modified intention-to-treat population. Safety including the incidence of exit-site infection or hemorrhage-associated catheter removal were also compared. This trial was registered with Clinical Research Information Service of Republic of Korea (KCT0005521).
Results
From November 2020 to March 2023, 1,324 participants were enrolled and randomly assigned to tPICC (n=662) and cPICC (n=662). This study was terminated early due to the cohort CLABSI rate being lower than estimated, therefore, the original sample size of 1,694 would render the study underpowered to detect a difference in CLABSI rates. In the tPICC, CLABSI occurred in 13 of 651 participants over 11,071 catheter-days (1.2/1,000 catheter-days), compared with 20 among 650 patients with cPICC over 11,141 catheter-days (1.8/1,000 catheter-days, rate ratio 0.65, 95% CI 0.30–1.38, p=0.30). The incidence of exit-site infection (29 tPICC, 36 cPICC, p=0.5) and hemorrhage-associated catheter removal (11 tPICC, 11 cPICC, p=0.99) was not different between both groups.
Conclusion
Due to insufficient sample size, this study could not demonstrate a statistically significant CLABSI risk reduction in the tPICC group compared to the cPICC group. Both groups had similar rates of exit site infection and bleeding.
期刊介绍：
The Journal of Hospital Infection is the editorially independent scientific publication of the Healthcare Infection Society. The aim of the Journal is to publish high quality research and information relating to infection prevention and control that is relevant to an international audience.
The Journal welcomes submissions that relate to all aspects of infection prevention and control in healthcare settings. This includes submissions that:
provide new insight into the epidemiology, surveillance, or prevention and control of healthcare-associated infections and antimicrobial resistance in healthcare settings;
provide new insight into cleaning, disinfection and decontamination;
provide new insight into the design of healthcare premises;
describe novel aspects of outbreaks of infection;
throw light on techniques for effective antimicrobial stewardship;
describe novel techniques (laboratory-based or point of care) for the detection of infection or antimicrobial resistance in the healthcare setting, particularly if these can be used to facilitate infection prevention and control;
improve understanding of the motivations of safe healthcare behaviour, or describe techniques for achieving behavioural and cultural change;
improve understanding of the use of IT systems in infection surveillance and prevention and control.
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