NCT05341687

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

April 14, 2022

Last Update Submit

July 16, 2024

Conditions

ArdsMechanical Ventilation Pressure HighExtracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Vital status (dead or alive)

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

    Days, 10.

Secondary Outcomes (3)

  • Evolution of driving pressure

    Days, 10

  • Evolution of tidal volume

    Days, 10

  • Evolution of PEEP

    days, 10

Interventions

No applicableOTHER

No applicable

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • Respiratory parameters not available on ten first day of VV ECMO implantation.
  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy

Nancy, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 22, 2022

Study Start

January 3, 2020

Primary Completion

December 31, 2021

Study Completion

May 1, 2023

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)