COMPLIECMO: Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05341687
• Collaborator: (none)
• Enrollment: 150
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

Mortality of patients with COVID-19 associated acute respiratory distress syndrome (CARDS) treated with veno-venous extra-corporal membrane oxygenation (vv-ECMO) is increasing over time since the beginning of the COVID-19 pandemic. The objectives were to retrospectively describe over the first ten days after vv-ECMO implantation, the ventilatory management of CARDS and to assess the impact of static respiratory system compliance (CRS) on the first day of vv-ECMO on 180-day mortality.

Condition or Disease	Intervention/Treatment	Phase
Ards; Mechanical Ventilation Pressure High; Extracorporeal Membrane Oxygenation	Other: No applicable

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (CARDS)
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Outcome Measures

Primary Outcome Measures

1. Vital status (dead or alive) [Days, 10.]

   according to compliance during the first ten days of VV ECMO implantation

Secondary Outcome Measures

1. Evolution of driving pressure [Days, 10]

   after VV-ECMO implantation

2. Evolution of tidal volume [Days, 10]

   after VV-ECMO implantation

3. Evolution of PEEP [days, 10]

   after VV-ECMO implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support, hospitalized in the intensive care units of the CHRU of Nancy, Marseille or Bordeaux between 01/03/2020 and 31/12/2021.

• Age > 18 years old

Exclusion Criteria:

• Respiratory parameters not available on ten first day of VV ECMO implantation.

• Patient refusal to participate in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthieu KOSZUTSKI, Principal investigator, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05341687
• Other Study ID Numbers: 2022PI050
• First Posted: Apr 22, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 15, 2022