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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04704388

Acronym

COMEBAC

Enrollment

478

Registered

2021-01-11

Start date

2020-06-01

Completion date

2020-10-01

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results