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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- EURO QoL 5D 5L quality-of-life score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
standard oxygen group
telephone interview comprising a quality of life questionnaire
Intervention: quality of life questionnaire (Other)
awake prone group
telephone interview comprising a quality of life questionnaire
Intervention: quality of life questionnaire (Other)
Outcomes
Primary Outcomes
EURO QoL 5D 5L quality-of-life score
Time Frame: 2 years after randomization
Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score
Secondary Outcomes
- Mortality at last follow-up time beyond 2 years after randomization(an average of 2 years follow up)
- Assessment of performance of daily activities(an average of 2 years follow up)
- Assessment of anxiety and depression(an average of 2 years follow up)
- Assessment of pain and discomfort(an average of 2 years follow up)
- Assessment of autonomy(an average of 2 years follow up)
- Assessment of mobility(an average of 2 years follow up)
- Number of points on the visual analog scale(an average of 2 years follow up)
- Family situation(before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.)
- Subgroup analysis:(an average of 2 years follow up)
- Hospitalisations(an average of 2 years follow up)
- Employment status(before hospitalization, then at 12, 24 months and at final follow-up.)