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

NCT05392062 | Completed

• 1 other identifier: PO21075
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Keywords

Gas exchange; COVID-19; acute respiratory distress syndrome; spontaneous breathing; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.

  Day 90

• Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.

  Day 28

• Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.

  At admission

Study Arms (1)

Respiratory insufficiency

OTHER

Subject with respiratory insufficiency

Other: Pathophysiology of gas exchange

Interventions

Pathophysiology of gas exchange OTHER

Exploration of pathophysiology of gas exchange

Respiratory insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients on mechanical ventilation on admission to the ICU.
• Patients requiring immediate intubation on admission.
• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: May 26, 2022
• Study Start: June 9, 2021
• Primary Completion: January 15, 2023
• Study Completion: April 15, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

FR (1)