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Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients
NCT06080737 · University Hospital, Tours
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-05-03
Estimated completion: 2025-12
Last updated: 2025-05-29
Interventions
Other: quality of life questionnaire
Primary outcomes
- • EURO QoL 5D 5L quality-of-life score (2 years after randomization)
Sponsor
University Hospital, Tours · other
Contacts & investigators
ContactStephan EHRMANN · contact · stephanehrmann@gmail.com · 0247479851
ContactTimothée BREHIN · contact · brehin.timothee@orange.fr
All locations (1)
university hospital ToursRecruiting
Tours, France