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

Recruiting

• Conditions: SARS-CoV 2 Pneumonia
• Interventions: Other: quality of life questionnaire

• Registration Number: NCT06080737
• Lead Sponsor: University Hospital, Tours

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 Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-12
• Status Verified: 2024-05
• Study Start: 2024-05-03
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard oxygen group	quality of life questionnaire	telephone interview comprising a quality of life questionnaire
awake prone group	quality of life questionnaire	telephone interview comprising a quality of life questionnaire

Primary Outcome Measures

Name	Time	Method
EURO QoL 5D 5L quality-of-life score	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 Outcome Measures

Name	Time	Method
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	Subpart of EURO QoL 5D 5L score
Assessment of anxiety and depression	an average of 2 years follow up	Subpart of EURO QoL 5D 5L score
Assessment of pain and discomfort	an average of 2 years follow up	Subpart of EURO QoL 5D 5L score
Assessment of autonomy	an average of 2 years follow up	Subpart of EURO QoL 5D 5L score
Assessment of mobility	an average of 2 years follow up	Subpart of EURO QoL 5D 5L score
Number of points on the visual analog scale	an average of 2 years follow up	Subpart of EURO QoL 5D 5L score
Family situation	before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.	Change of family situation
Subgroup analysis:	an average of 2 years follow up	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
Hospitalisations	an average of 2 years follow up	Number of new hospitalizations during follow-up period
Employment status	before hospitalization, then at 12, 24 months and at final follow-up.	Change of employment status

Trial Locations

Locations (1)

university hospital Tours; 🇫🇷 Tours, France