Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels

ARDS Due to Disease Caused by SARS Co-V-2 Clinical Trial

— COMPLI-QUO  

Official title:

Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721768
• Other study ID #: 2022PI195
• Status: Recruiting
• Start date: February 24, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: simon valentin, MD
• Phone: +3383153405
• Email: simon.valentin[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration of the compliance of the respiratory system are at greater risk of developing respiratory sequelae.

Studying the altered compliance of the respiratory system in ARDS secondary to COVID-19 and its relationship to the development of respiratory sequelae would help us to improve the management of patients with COVID-19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized in intensive care medicine between 01/03/2030 and 01/09/2022 (with invasive mechanical ventilation for at least 48 hours for a SARS-CoV-2 infection documented by RT-PCR) who were followed in pulmonary outpatient medicine at least 3 months after their hospitalization in intensive care medicine and before 01/12/2022 and who had respiratory sequelae during this period.

• Hospitalized in intensive care medicine between 01/03/2020 and 01/12/2021 (with invasive mechanical ventilation for at least 48 hours for SARS-CoV-2 infection documented by RT-PCR) who were followed up in pulmonary outpatient medicine but did not have respiratory sequelae between 01/06/2020 and 01/12/2022.

Exclusion Criteria:

• Documented underlying respiratory pathology.

• Pneumothorax within the first 10 days.

• Patient requiring extracorporeal circulatory support.

• Refusal to participate

• Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or breastfeeding mother / Minor (not emancipated) / Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) / Adult unable to express his consent

• Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.

• Respiratory system compliance data not available on the computer software

Related Conditions & MeSH terms

• Respiratory Compliance

Locations

Country	Name	City	State
France	Valentin Simon	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of respiratory sequelae	Presence of respiratory sequelae (FVC <80% or DLCO <70% or radiologic sequelae attributable to SARS-CoV-2) at M3 or M6 or M12	1 year