Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study (EXTUB ECLS)

September 25, 2017 updated by: Centre Hospitalier Universitaire Dijon
There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • Chu Dijon Bourogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on ECLS

Description

Inclusion Criteria:

- Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15

Exclusion Criteria:

  • Patients under 18 years old
  • Patients on ECLS for a heart transplant
  • Patients who died within the first 48 hours following the initiation of ECLS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with extubation while on ECLS
Patients without extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • LAMIREL-GIRARD 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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