Comparison of 2 Ventilatory Support Strategies During Coronavirus Disease 2019 (Covid-19) Pneumonia (STRATIC)

October 10, 2022 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83056
        • Hôpital Sainte Musse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Invasive strategy group
Patients admitted in ICU with Covid-19 related pneumonia during COVID19 first period.
Procedure: Invasive ventilation strategy
Use of an invasive ventilatory support strategy
Non-invasive strategy group
Patients admitted in ICU with Covid-19 related pneumonia during COVID19 second period.
Procedure: Non-invasive ventilation strategies
Use of non-invasive ventilatory support strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in ICU
Time Frame: At the moment of ICU discharge or death, up to 3 month
Number of days spent in ICU
At the moment of ICU discharge or death, up to 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: At the moment of ICU discharge or death, up to 3 month
Rate of patients alive at the moment of intensive care unit discharge
At the moment of ICU discharge or death, up to 3 month
Complications
Time Frame: At the moment of ICU discharge or death, up to 3 month
Number of complications during intensive care unit stay
At the moment of ICU discharge or death, up to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Aude Garnero, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-CHITS-004

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Invasive ventilation strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe