Long-term effects of awake positioning in COVID-19 ICU patients
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
This study looks at how being awake and lying on their stomach helped COVID-19 patients in the ICU feel in the long run after they recovered.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Tours) |
| Trial ID | NCT06080737 on ClinicalTrials.gov |
What this trial studies
This study follows up on patients who participated in a previous trial assessing the effects of awake prone positioning on COVID-19 patients with pneumonia. It aims to evaluate the long-term quality of life of those who survived and were not lost to follow-up after 28 days. Participants will be contacted for a telephone interview to gather data on their health outcomes and overall well-being. The study focuses on understanding the lasting impacts of this positioning strategy on patients' lives.
Who should consider this trial
Good fit: Ideal candidates are patients who participated in the initial trial and survived beyond 28 days.
Not a fit: Patients who were lost to follow-up or withdrew consent from the initial trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving long-term quality of life for COVID-19 survivors.
How similar studies have performed: Previous studies on awake prone positioning have shown promising results, indicating potential benefits for patients with acute respiratory distress syndrome.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tours
- university hospital Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Stephan EHRMANN
- Email: stephanehrmann@gmail.com
- Phone: 0247479851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.