NCT04155723

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

October 25, 2019

Last Update Submit

July 11, 2023

Conditions

Keywords

Midlines

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 21511081BACKGROUND
  • Pathak 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: 25972725BACKGROUND
  • Pathak 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: 30174427BACKGROUND
  • Xu 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: 27908432BACKGROUND
  • Shokoohi 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: 23141920BACKGROUND
  • Alexandrou 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

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

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

Locations