Impact of a Task Delegation to ICU Nurses for Midlines' Placement
IDEM
1 other identifier
observational
310
1 country
1
Brief Summary
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters. Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis. The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 12, 2023
July 1, 2023
3.2 years
October 25, 2019
July 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of exposure to central venous catheter
Duration of exposure to central venous catheter (catheter-days per patient-day)
ICU discharge (usually seven days)
Secondary Outcomes (11)
Duration of exposure to peripheral venous catheter
ICU discharge (usually seven days)
Duration of exposure to Midline
ICU discharge (usually seven days)
Number of catheter-related infections
ICU discharge (usually seven days)
Number of catheter-related infections
Hospital discharge (usually two weeks)
Number of catheter-related thrombosis
ICU discharge (usually seven days)
- +6 more secondary outcomes
Study Arms (2)
Phase 1 group
During phase 1, Midlines are inserted only by doctors.
Phase 2 group
During Phase 2, Midlines are preferentially inserted by ICU nurses, and if needed, by doctors.
Eligibility Criteria
Patients hospitalized in ICU for more than 48 hours
You may qualify if:
- Adult patients hospitalized in ICU for more than 48 hours
You may not qualify if:
- Patient under 18 years old
- Patient under legal guardianship
- Absence of health insurance in France
- Refusal of the patient or his next-of-kin
- Patient with a decision of withholding or withdrawing of life sustaining therapy
- Patient with a subcutaneous central venous port
- Impossibility of infusion on the upper limbs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Bretagne Sud
Lorient, 56100, France
Related Publications (6)
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PMID: 21511081BACKGROUNDPathak R, Patel A, Enuh H, Adekunle O, Shrisgantharajah V, Diaz K. The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population. Infect Dis Clin Pract (Baltim Md). 2015 May;23(3):131-134. doi: 10.1097/IPC.0000000000000237.
PMID: 25972725BACKGROUNDPathak R, Gangina S, Jairam F, Hinton K. A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital. Ther Clin Risk Manag. 2018 Aug 21;14:1453-1456. doi: 10.2147/TCRM.S171748. eCollection 2018.
PMID: 30174427BACKGROUNDXu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.
PMID: 27908432BACKGROUNDShokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
PMID: 23141920BACKGROUNDAlexandrou E, Spencer TR, Frost SA, Mifflin N, Davidson PM, Hillman KM. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates--a report from 13 years of service*. Crit Care Med. 2014 Mar;42(3):536-43. doi: 10.1097/CCM.0b013e3182a667f0.
PMID: 24145843BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 25, 2019
First Posted
November 7, 2019
Study Start
November 6, 2019
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share