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

Study Overview
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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.

Official Title
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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

Conditions
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SARS-CoV 2 Pneumonia

Intervention / Treatment
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* Other: quality of life questionnaire


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| standard oxygen group<br>telephone interview comprising a quality of life questionnaire | Other: quality of life questionnaire<br>* telephone interview to assess mortality and quality of life in the population included in a trial<br>|
| awake prone group<br>telephone interview comprising a quality of life questionnaire | Other: quality of life questionnaire<br>* telephone interview to assess mortality and quality of life in the population included in a trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EURO QoL 5D 5L quality-of-life score | Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score | 2 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at last follow-up time beyond 2 years after randomization |  | an average of 2 years follow up | 
| Assessment of autonomy | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Assessment of mobility | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Assessment of performance of daily activities | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Assessment of pain and discomfort | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Assessment of anxiety and depression | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Number of points on the visual analog scale | Subpart of EURO QoL 5D 5L score | an average of 2 years follow up | 
| Hospitalisations | Number of new hospitalizations during follow-up period | an average of 2 years follow up | 
| Family situation | Change of family situation | before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up. | 
| Employment status | Change of employment status | before hospitalization, then at 12, 24 months and at final follow-up. | 
| Subgroup analysis: | analysis of primary endpoint, mortality, and subparts of the EURO QoL 5D 5L score in subgroups of patients who were intubated or not during follow-up in the initial meta-assay | an average of 2 years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term quality of life, awake prone positioning, acute respiratory distress syndrome