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

Sponsor
CHU de Reims (Other)
Overall Status
Recruiting
CT.gov ID
NCT05392062
Collaborator
(none)
156
1
1
15
10.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pathophysiology of gas exchange
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
Actual Study Start Date :
Jun 9, 2021
Anticipated Primary Completion Date :
Jun 9, 2022
Anticipated Study Completion Date :
Sep 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Respiratory insufficiency

Subject with respiratory insufficiency

Other: Pathophysiology of gas exchange
Exploration of pathophysiology of gas exchange

Outcome Measures

Primary Outcome Measures

  1. Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation. [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

Secondary Outcome Measures

  1. Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90. [Day 90]

    No provided

  2. Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28. [Day 28]

    No provided

  3. Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan. [At admission]

    No provided

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damien JOLLY Reims France

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT05392062
Other Study ID Numbers:
  • PO21075
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHU de Reims
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022