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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392062
Other study ID # PO21075
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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