Extended Prone Position Duration COVID-19-related ARDS: a Retrospective Study

November 16, 2021 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study

Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute respiratory distress syndrome (ARDS) is a severe condition in which diffuse ventilation/perfusion mismatching and intra-pulmonary shunt are responsible for profound hypoxemia. In patients with severe ARDS, prone position (PP) improves oxygenation and reduces mortality. Recommendations suggest that PP sessions should last at least 16 consecutive hours. Safety concern is mainly related to the risk of pressure injuries.

In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation (MV) and PP in the Intensive Care Units (ICUs) worldwide.

In the ICU of Louis Mourier hospital (Colombes, France) investigators decided upon a strategy whereby PP sessions duration was extended up to 48 hours in patients with COVID-19-related ARDS, so as to minimize the number and workload of turning procedures, limit staff exposure to viral contamination, and avoid turning patients during night shifts.

Here, investigators aim to report incidence of skin complications (pression injuries) in patients who underwent at least one prolonged PP session. Secondary objective was to evaluate evolution of ventilatory parameters with prolonged PP sessions.

Study Type

Observational

Enrollment (Actual)

81

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

  • France
      • Colombes, France, 92700
        • Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

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

Non-Probability Sample

Study Population

adult, ICU, COVID-19 related ARDS patients with profound hypoxemia requiring invasive mechanical ventilation and prone position

Description

Inclusion Criteria:

  • COVID-19 proven by PCR-testing of respiratory specimen
  • Acute respiratory distress syndrome (Berlin definition) requiring invasive mechanical ventilation and prone position
  • at least one session of prolonged prone position (that includes two consecutive nights in prone position)

Exclusion Criteria:

  • transfer to another ICU facility after initial admission (inter-regional regulation of ICU beds' availability)

    • Incomplete or missing medical file
    • Refusal to consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session
patients with COVID-19 related ARDS requiring prone position because of profound hypoxemia were applied the investigators' strategy to extend duration of prone position: after being turned prone, they spent at least two complete nights in prone position before being turned to supine position
Other: prone position
extension of prone position duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of skin complications (pressure injuries)
Time Frame: from first prone position session to Day-28 or ICU discharge, whichever comes first
overall and per stage (from stage 1 to stage 4) incidence of pressure injuries
from first prone position session to Day-28 or ICU discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial blood gases
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
changes in arterial blood gases (partial pressure in oxygen, carbon dioxide and pH)
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
plateau pressure
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
teleinspiratory pause pressure
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
driving pressure
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
plateau minus positive end-expiratory pressure
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
respiratory compliance system
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
volume over pressure ratio of the respiratory system
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
positive end-expiratory pressure
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
positive end-expiratory pressure
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
inspired oxygen fraction
Time Frame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
inspired oxygen fraction
through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)

Collaborators and Investigators

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

Sponsor

Hôpital Louis Mourier

Investigators

  • Principal Investigator: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLM_JDR10

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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