Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care

Completed

• Conditions: Covid19

• Registration Number: NCT04704388
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2

• Major
• Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
• proven SARS-CoV-2 infection
• Treated by invasive mechanical ventilation or high flow humidified oxygen with FiO2 ≥50% for more than 48 hours.

Group 2: patients hospitalized outside intensive care units

• Major
• Admitted between March 1 and May 10, 2020 in an area of Bicêtre hospital having cared for patients infected with SARS-CoV-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology.

Exclusion Criteria

• Patients having refused the post consultation at 3 month
• Without social security coverage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post-intensive care syndrome (PICS)	3 month after hospitalisation	To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia.

Secondary Outcome Measures

Name	Time	Method
Evaluate the 3-month mortality of patients released alive from intensive care	3 month after end of hospitalisation	Number of patient deceased
Describe the overall state of health and the main organ sequelae of these patients	3 month after hospitalisation	Description of the data collected
functional respiratory sequelae	3 month after hospitalisation	Compare the functional respiratory sequelae of these patients to those who were hospitalized outside of critical care for COVID-19 pneumonia requiring lower oxygen support.

Trial Locations

Locations (1)

Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France