Study Stopped
No more Covid patients in the service and number of patients included sufficient for stastistical analysis.
Diaphragm Dysfunction in ARDS Patients With V-V ECMO
DD-ECMO
Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
1 other identifier
interventional
63
1 country
1
Brief Summary
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
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 15, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedJune 15, 2022
May 1, 2022
8 months
October 15, 2020
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diaphragm function
as defined by the pressure generating capacity of the diaphragm \< 11 cmH2O
until day 28
Secondary Outcomes (2)
Duration of ECMO
until day 60
Duration of invasive mechanical ventilation
until day 60
Study Arms (1)
experimental group
EXPERIMENTALA single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
Interventions
A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
Eligibility Criteria
You may qualify if:
- age \> 18 years
- ARDS according to the Berlin definition
- V-V ECMO
- patient or next of kin agrees to participate
- patient with health insurance
You may not qualify if:
- pregnancy
- Opposition to participate
- Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013, France
Related Publications (1)
Gautier M, Joussellin V, Ropers J, El Houari L, Demoule A, Similowski T, Combes A, Schmidt M, Dres M. Diaphragm function in patients with Covid-19-related acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation. Ann Intensive Care. 2023 Sep 26;13(1):92. doi: 10.1186/s13613-023-01179-w.
PMID: 37752337DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin Dres
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
November 3, 2020
Study Start
February 15, 2021
Primary Completion
October 15, 2021
Study Completion
October 15, 2021
Last Updated
June 15, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share