NCT03295357

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 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

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 25, 2017

Last Update Submit

September 25, 2017

Conditions

Extra-Corporeal Life Support

Outcome Measures

Primary Outcomes (1)

  • Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU

    At baseline

Study Arms (2)

Patients with extubation while on ECLS

Patients without extubation

Eligibility Criteria

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

Patients on ECLS

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 27, 2017

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 27, 2017

Record last verified: 2017-09

Locations

FR(1)