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NCT05341687 Clinical Trial

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

Ards Clinical Trial

— COMPLIECMO  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05341687
Other study ID # 2022PI050
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date November 1, 2022

Study information
Verified date August 2022
Source Central Hospital, Nancy, France
Contact Benjamin PEQUIGNOT, MD
Phone +3383153851
Email b.pequignot@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date November 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Ards
  • Extracorporeal Membrane Oxygenation
  • Mechanical Ventilation Pressure High

Intervention

Other:
• No applicable
No applicable

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary Vital status (dead or alive) according to compliance during the first ten days of VV ECMO implantation Days, 10.
Secondary Evolution of driving pressure after VV-ECMO implantation Days, 10
Secondary Evolution of tidal volume after VV-ECMO implantation Days, 10
Secondary Evolution of PEEP after VV-ECMO implantation days, 10
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