NCT04799691

Brief Summary

This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

March 15, 2021

Last Update Submit

October 10, 2022

Conditions

COVID-19

Keywords

Invasive strategyNon-invasive strategyContinuous Positive Airway PressureHigh Flow Nasal CanulaProne position

Outcome Measures

Primary Outcomes (1)

  • Length of stay in ICU

    Number of days spent in ICU

    At the moment of ICU discharge or death, up to 3 month

Secondary Outcomes (2)

  • Mortality

    At the moment of ICU discharge or death, up to 3 month

  • Complications

    At the moment of ICU discharge or death, up to 3 month

Study Arms (2)

Invasive strategy group

Patients admitted in ICU with Covid-19 related pneumonia during COVID19 first period.

Procedure: Invasive ventilation strategy

Non-invasive strategy group

Patients admitted in ICU with Covid-19 related pneumonia during COVID19 second period.

Procedure: Non-invasive ventilation strategies

Interventions

Invasive ventilation strategyPROCEDURE

Use of an invasive ventilatory support strategy

Invasive strategy group
Non-invasive ventilation strategiesPROCEDURE

Use of non-invasive ventilatory support strategies

Non-invasive strategy group

Eligibility Criteria

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

Patients with COVID 19 acute hypoxemic respiratory failure admitted in Hospital Sainte Musse ICU in 2020

You may qualify if:

  • Patient with confirmed SARS COV2 infection
  • Acute Respiratory Distress Syndrome
  • Patient more than 18 year old

You may not qualify if:

  • Intensive Care Unit admission for extra pulmonary failure
  • "Do Not Reanimated" order
  • Patient from another Intensive Care Unit
  • Patient objection
  • Judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Sainte Musse

Toulon, Var, 83056, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Aude Garnero, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 16, 2021

Study Start

February 1, 2021

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)