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

NCT06080737 | Completed

• 1 other identifier: DR 230170 - Long-term APP
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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)

Conditions

SARS-CoV 2 Pneumonia

Keywords

long-term quality of life; awake prone positioning; acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mortality at last follow-up time beyond 2 years after randomization

  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

• Assessment of performance of daily activities

  an average of 2 years follow up

• Assessment of pain and discomfort

  an average of 2 years follow up

Study Arms (2)

standard oxygen group

telephone interview comprising a quality of life questionnaire

Other: quality of life questionnaire

awake prone group

telephone interview comprising a quality of life questionnaire

Other: quality of life questionnaire

Interventions

quality of life questionnaire OTHER

telephone interview to assess mortality and quality of life in the population included in a trial

awake prone group; standard oxygen group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

university hospital Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 12, 2023
• Study Start: May 3, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)