Skip to main content
OpenTrials
Completed

NCT Number: NCT06080737

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV 2 Pneumonia Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

university hospital Tours

Tours, 37000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life Questionnaire

Other

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

Primary outcomes

  1. 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

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

    Time frame: an average of 2 years follow up

  2. Assessment of autonomy

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  3. Assessment of mobility

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  4. Assessment of performance of daily activities

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  5. Assessment of pain and discomfort

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  6. Assessment of anxiety and depression

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  7. Number of points on the visual analog scale

    Time frame: an average of 2 years follow up

    Subpart of EURO QoL 5D 5L score

  8. Hospitalisations

    Time frame: an average of 2 years follow up

    Number of new hospitalizations during follow-up period

  9. Family situation

    Time frame: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.

    Change of family situation

  10. Employment status

    Time frame: before hospitalization, then at 12, 24 months and at final follow-up.

    Change of employment status

  11. Subgroup analysis:

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: Long-termAPP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.