Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)

June 2, 2022 updated by: Piquilloud Imboden Lise, University of Lausanne Hospitals

Physiological Response to Prone Position in Intubated Adults With COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): a Retrospective Study

Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

COVID-19 moderate to severe ARDS patients who sustained prone positioning

Description

Inclusion Criteria:

  • COVID-19 associated moderate to severe ARDS
  • Invasive mechanical ventilation
  • Prone positioning
  • admitted to ICU

Exclusion Criteria:

  • already sustained prone positioning in referring hospital
  • pronation during ECMO only
  • denied consent for data analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2/FiO2
Time Frame: Within 2 hours before pronation and 2 hours before supination
Arterial partial pressure of oxygen / Fraction of inspired oxygen
Within 2 hours before pronation and 2 hours before supination

Secondary Outcome Measures

Outcome Measure
Time Frame
Alveolo-arterial oxygen gradient change
Time Frame: Within 2 hours before pronation and 2 hours before supination
Within 2 hours before pronation and 2 hours before supination
Ventilatory Ratio
Time Frame: Within 2 hours before pronation and 2 hours before supination
Within 2 hours before pronation and 2 hours before supination
Mortality or Extracorporeal membrane oxygenation (ECMO) support
Time Frame: Once between ICU admission and extubation
Once between ICU admission and extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prone_COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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