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Clinical Trials/NCT04704388
NCT04704388
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country478 target enrollmentJune 1, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
478
Locations
1
Primary Endpoint
post-intensive care syndrome (PICS)
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
October 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

post-intensive care syndrome (PICS)

Time Frame: 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 Outcomes

  • Evaluate the 3-month mortality of patients released alive from intensive care(3 month after end of hospitalisation)
  • Describe the overall state of health and the main organ sequelae of these patients(3 month after hospitalisation)
  • functional respiratory sequelae(3 month after hospitalisation)

Study Sites (1)

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