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

SARS-CoV 2 Pneumonia Clinical Trial

— Long-termAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080737
• Other study ID #: DR 230170 - Long-term APP
• Status: Recruiting
• Start date: May 3, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Tours
• Contact: Stephan EHRMANN
• Phone: 0247479851
• Email: stephanehrmann[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• SARS-CoV 2 Pneumonia

Intervention

Other:
• quality of life questionnaire
telephone interview to assess mortality and quality of life in the population included in a trial

Locations

Country	Name	City	State
France	university hospital Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality at last follow-up time beyond 2 years after randomization		an average of 2 years follow up
Secondary	Assessment of autonomy	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Assessment of mobility	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Assessment of performance of daily activities	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Assessment of pain and discomfort	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Assessment of anxiety and depression	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Number of points on the visual analog scale	Subpart of EURO QoL 5D 5L score	an average of 2 years follow up
Secondary	Hospitalisations	Number of new hospitalizations during follow-up period	an average of 2 years follow up
Secondary	Family situation	Change of family situation	before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.
Secondary	Employment status	Change of employment status	before hospitalization, then at 12, 24 months and at final follow-up.
Secondary	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