Early Use of Prone Position in ECMO for Severe ARDS

February 5, 2024 updated by: Rui Wang, Beijing Chao Yang Hospital

Early Use of Prone Position in Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is widely used in the salvage treatment of critical acute respiratory distress syndrome (ARDS). However, reducing lung injury, accelerating lung recovery, shortening VV-ECMO support time, and decreasing complications during the treatment need further study. By changing the body position of ARDS patients, the prone position can increase the lung's dorsal ventilation and improve the lung's ventilation/blood flow ratio to improve oxygenation. Previous multicenter studies have proved that the prone position can significantly reduce the mortality of patients with moderate and severe ARDS. However, patients with severe ARDS rescue by VV-ECMO rarely combine with a prone position.On the one hand, with the support of ECMO, the patient's oxygenation will be significantly improved, and they will no longer need the assistance of a prone position. In addition, the ECMO cannula brings some challenges to implementing a prone position. Only a few cohort studies have reported that VV-ECMO combined with a prone position could improve the oxygenation index and respiratory system compliance during the late treatment period.

The initial reason for PP in ARDS patients was to alleviate severe hypoxemia, as it was an efficient means to improve oxygenation in most patients. However, some patients were categorized as non-responders in the PP regarding oxygenation, which caused VV-ECMO therapy to be initiated. Should we decide to perform PP after VV-ECMO therapy no longer? This study evaluates whether early use of PP during VV-ECMO would increase the proportion of patients successfully weaned from VV-ECMO support compared with supine positioning in severe ARDS patients who received PP before ECMO.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had undergone PP as rescue therapy before VV-ECMO

Description

Inclusion Criteria:

  1. met the diagnostic criteria of Berlin's definition for ARDS;
  2. had undergone prone positing before VV-ECMO；
  3. receiving VV-ECMO support

Exclusion Criteria:

  1. spinal instability；
  2. elevated intracranial pressure;
  3. facial/neck trauma;
  4. recent sternotomy;
  5. large ventral surface burn;
  6. multiple trauma with unstabilized fractures;
  7. severe hemodynamic instability;
  8. massive hemoptysis;
  9. high risk of requiring CPR or defibrillation;

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
Prone group
  1. Prone position within 24 hours after VV-ECMO support.
  2. Prone position for at least 16 hours per day for a minimum of 5 days.
Procedure: Prone positon
Prone position within 24 hours after VV-ECMO support. Prone position for at least conservative hours per day for a minimum of 5 days.
Supine group
1. Supine group on ECMO.
Procedure: Supine positon
Conventional supine position ventilation, no prone position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients successfully weaned from VV-ECMO,
Time Frame: After patients enrolled 60 days
Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO
After patients enrolled 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60-day mortality
Time Frame: After patients enrolled 60 days
Mortality rate at 60 days of VV-ECMO support
After patients enrolled 60 days

Collaborators and Investigators

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

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Bing Sun, Dr., Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

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)

November 1, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-KE-171

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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