NCT04350710

Brief Summary

The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 18, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 9, 2020

Last Update Submit

April 14, 2020

Conditions

Acute Respiratory Distress SyndromeCOVID

Keywords

COVIDAcute Respiratory Distress SyndromeSARS CoV-2Lung recruitabilityRespiratory mechanics

Outcome Measures

Primary Outcomes (3)

  • Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Day 1

  • Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Day 5

  • Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Day 10

Secondary Outcomes (43)

  • PaO2/FiO2 (mmHg)

    Day 1

  • PaO2/FiO2 (mmHg)

    Day 5

  • PaO2/FiO2 (mmHg)

    Day 10

  • Lung volume recruited (VRec)

    Day 1

  • Lung volume recruited (VRec)

    Day 5

  • +38 more secondary outcomes

Interventions

PEEP trialOTHER

Measurement of Recruitment-to-Inflation Ratio

Eligibility Criteria

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

Mechanically Ventilated adult patients with COVID-19 Associated ARDS

You may qualify if:

  • ARDS criteria according to Berlin classification criteria
  • Invasive mechanical ventilation on endotracheal tube
  • SARS Cov-2 infection

You may not qualify if:

  • pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Angers, 49100, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • François BELONCLE, MCU PH

    CHU Angers, Médecine intensive réanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François BELONCLE, MCU PH

CONTACT

0241345866Francois.Beloncle@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 17, 2020

Study Start

March 18, 2020

Primary Completion

April 20, 2020

Study Completion

December 31, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)