Back to resultsPathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study. (COVAQ)
Primary Purpose
Respiratory Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pathophysiology of gas exchange
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Insufficiency focused on measuring Gas exchange, COVID-19, acute respiratory distress syndrome, spontaneous breathing, Respiratory failure
Eligibility Criteria
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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Respiratory insufficiency
Arm Description
Subject with respiratory insufficiency
Outcomes
Primary Outcome Measures
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
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
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
No provided
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
No provided
Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
No provided
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05392062
Brief 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.
Acronym
COVAQ
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
June 9, 2022 (Anticipated)
Study Completion Date
September 9, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Gas exchange, COVID-19, acute respiratory distress syndrome, spontaneous breathing, Respiratory failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Respiratory insufficiency
Arm Type
Other
Arm Description
Subject with respiratory insufficiency
Intervention Type
Other
Intervention Name(s)
Pathophysiology of gas exchange
Intervention Description
Exploration of pathophysiology of gas exchange
Primary Outcome Measure Information:
Title
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
Description
From date of admission in intensive care unit (ICU) until the date of death or disharge from ICU, assessed up to 90 days
Time Frame
Lenght of hospital stay in intensive care unit
Secondary Outcome Measure Information:
Title
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
Description
No provided
Time Frame
Day 90
Title
Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
Description
No provided
Time Frame
Day 28
Title
Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
Description
No provided
Time Frame
At admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine GOURY
Phone
03 10 73 68 85
Ext
0033
Email
agoury@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine GOURY
Phone
03 10 73 68 85
Ext
0033
Email
agoury@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
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