Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients

NCT ID: NCT06080737

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-03

Study Completion Date

2025-12-31

Brief Summary

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Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

Detailed Description

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All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.

Conditions

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SARS-CoV 2 Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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standard oxygen group

telephone interview comprising a quality of life questionnaire

quality of life questionnaire

Intervention Type OTHER

telephone interview to assess mortality and quality of life in the population included in a trial

awake prone group

telephone interview comprising a quality of life questionnaire

quality of life questionnaire

Intervention Type OTHER

telephone interview to assess mortality and quality of life in the population included in a trial

Interventions

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quality of life questionnaire

telephone interview to assess mortality and quality of life in the population included in a trial

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021).
* Patients alive at D28
* No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.

Exclusion Criteria

* Patients lost to follow-up after 28 days.
* Withdrawal of consent from randomized meta-trial by patient
* Vulnerable person: safeguard of justice, curatorship, or guardianship
* Patients refusing to answer telephone questionnaire.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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university hospital Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stephan EHRMANN

Role: CONTACT

0247479851 ext. +33

Timothée BREHIN

Role: CONTACT

Facility Contacts

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Stephan EHRMANN

Role: primary

Timothée BREHIN

Role: backup

Other Identifiers

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DR 230170 - Long-term APP

Identifier Type: -

Identifier Source: org_study_id

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