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

Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (CARDS)

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation; Ards; Mechanical Ventilation Pressure High
• Intervention / Treatment: Other: No applicable

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • CHU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital status (dead or alive)	according to compliance during the first ten days of VV ECMO implantation	Days, 10.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of driving pressure	after VV-ECMO implantation	Days, 10
Evolution of tidal volume	after VV-ECMO implantation	Days, 10
Evolution of PEEP	after VV-ECMO implantation	days, 10

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022PI050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No