Extra-Corporeal Life SupportEXTUB ECLSNCT03295357
Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study
An observational study of Extra-Corporeal Life Support, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extra-Corporeal Life Support
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on ECLS
Who may be able to join
- Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Extra-Corporeal Life Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with extubation while on ECLS | Not described | |
| Patients without extubation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extra-Corporeal Life SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295357
- Sponsor's protocol ID
- LAMIREL-GIRARD 2016
- Acronym
- EXTUB ECLS
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 27 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study
- ClinicalTrials.gov ID
- NCT03295357
- Acronym / sponsor ID
- EXTUB ECLS / LAMIREL-GIRARD 2016
- Conditions
- Extra-Corporeal Life Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with extubation while on ECLS | – | – |
| Patients without extubation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on ECLS
Key inclusion criteria (1 listed)
- Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
Related trials for Extra-Corporeal Life Support
RecruitingObservational study
PERCEPTION - Super-Early Neuroprognostication in eCPR Patients
Resuscitation, Extra Corporeal Life Support
RecruitingObservational study
Recovery From ICUAW Following Severe Respiratory and Cardiac Failure
Intensive Care Unit Syndrome, Intensive Care Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extra-Corporeal Life Support, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.