Altered Respiratory Compliance Under Invasive Mechanical... | NCT05721768

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

NCT05721768

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Feb 28, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

ARDS Due to Disease Caused by SARS Co-V-2
Respiratory Compliance
Sequels of COVID

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2023Actual

Primary Completion Date

Mar 15, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

Feb 1, 2023

First Posted Date

Feb 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2023

Last Update Posted Date

Feb 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients followed in the Outpatient Medicine Unit of the Respiratory Department of the Nancy University Hospital in the framework of the post COVID-19 follow-up, previously hospitalized in intensive care medicine and intensive care unit.

Sampling Method

Non-Probability Sample