Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol

被引：13

作者：

Ullman, Amanda J. ^{[1
,2
,3
,4
]}

August, Deanne ^{[1
,2
,4
]}

Kleidon, Tricia ^{[1
,2
,3
]}

Walker, Rachel ^{[2
,5
]}

Marsh, Nicole M. ^{[1
,2
,4
]}

Bulmer, Andrew ^{[2
]}

Pearch, Benjamin ^{[5
]}

Runnegar, Naomi ^{[5
,6
]}

Schults, Jessica A. ^{[1
,3
,4
]}

Leema, Joanne ^{[2
,5
]}

Lee-Archer, Paul ^{[3
,6
]}

Biles, Cathy ^{[5
]}

Southam, Katrina ^{[4
]}

Gibson, Victoria ^{[1
,2
,3
]}

Byrnes, Joshua ^{[2
]}

Ware, Robert S. ^{[2
]}

Chopra, Vineet ^{[2
,7
]}

Coulthard, Alan ^{[4
,6
]}

Mollee, Peter ^{[5
,6
]}

Rickard, Claire M. ^{[1
,2
,4
]}

Harris, Patrick N. A. ^{[4
,6
]}

机构：

[1] Univ Queensland, Sch Nursing Midwifery & Social Work, St Lucia, Qld, Australia

[2] Griffith Univ, Menzies Hlth Inst Queensland, Nathan, Qld, Australia

[3] Queensland Childrens Hosp, Childrens Hlth Queensland Hosp & Hlth Serv, Brisbane, Qld, Australia

[4] Royal Brisbane & Womans Hosp, Metro North Hlth Serv Dist, Herston, Qld, Australia

[5] Princess Alexandra Hosp, Metro South Hlth Serv Dist, Woolloongabba, Qld, Australia

[6] Univ Queensland, Fac Med, St Lucia, Qld, Australia

[7] Univ Michigan, Dept Med, Ann Arbor, MI 48109 USA

来源：

BMJ OPEN | 2021年 / 11卷 / 04期

基金：

英国医学研究理事会;

关键词：

BLOOD-STREAM INFECTION; CENTRAL VENOUS CATHETERS; ACCESS DEVICES; RISK; THROMBOEMBOLISM; COMPLICATIONS; SECUREMENT;

D O I：

10.1136/bmjopen-2020-042475

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications. Methods and analysis A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure, a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI. Ethics and dissemination Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published.

引用

页数：7

共 32 条

[1]

Australian Commission on Safety and Quality in Health Care, 2020, AUSTR HOSP PAT EXP Q

[2]

Children's Health Queensland Hospital and Services, 2018, VEN ACC DEV VAD INS

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