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

Respiratory Insufficiency Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05392062
• Other study ID #: PO21075
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: September 9, 2022

Study information

• Verified date: August 2021
• Source: CHU de Reims
• Contact: Antoine GOURY
• Phone: 03 10 73 68 85
• Email: agoury[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: September 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pulmonary Valve Insufficiency
• Respiratory Aspiration
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lenght of hospital stay in intensive care unit
Secondary	Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.	No provided	Day 90
Secondary	Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.	No provided	Day 28
Secondary	Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.	No provided	At admission