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 Overview
=================
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.

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.

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Other: Pathophysiology of gas exchange


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Respiratory insufficiency<br>Subject with respiratory insufficiency | Other: Pathophysiology of gas exchange<br>* Exploration of pathophysiology of gas exchange<br>|

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gas exchange, COVID-19, acute respiratory distress syndrome, spontaneous breathing, Respiratory failure