Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study. (COVAQ)

December 11, 2024 updated by: CHU de Reims
The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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
      • Reims, France
        • Damien JOLLY

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

Description

inclusion criteria :

  • Patients with a COVID-19 confirmed infection.
  • Admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask.
  • Presence of an arterial catheter for blood sampling.

exclusion criteria :

  • Patients on mechanical ventilation on admission to the ICU.
  • Patients requiring immediate intubation on admission.
  • Patients admitted to the ICU for more than 48 hours at the time of inclusion.
  • Pulmonary embolism diagnosed before admission to the ICU.
  • Minor patients
  • Pregnant women
  • Patients under curatorship or guardianship
  • Persons deprived of liberty by a judicial or administrative decision

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Respiratory insufficiency
Subject with respiratory insufficiency
Other: Pathophysiology of gas exchange
Exploration of pathophysiology of gas exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
Time Frame: Lenght of hospital stay in intensive care unit
From date of admission in intensive care unit (ICU) until the date of death or disharge from ICU, assessed up to 90 days
Lenght of hospital stay in intensive care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
Time Frame: Day 90
No provided
Day 90
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
Time Frame: Day 28
No provided
Day 28
Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
Time Frame: At admission
No provided
At admission

Collaborators and Investigators

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

Sponsor

CHU de Reims

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)

June 9, 2021

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO21075

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.

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