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Clinical Trials/NCT04139733
NCT04139733
Recruiting
Not Applicable

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

Beijing Chao Yang Hospital1 site in 1 country160 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Adult
Sponsor
Beijing Chao Yang Hospital
Enrollment
160
Locations
1
Primary Endpoint
The proportion of patients successfully weaned from VV-ECMO,
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
October 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rui Wang

Attending doctors

Beijing Chao Yang Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • spinal instability;
  • elevated intracranial pressure;
  • facial/neck trauma;
  • recent sternotomy;
  • large ventral surface burn;
  • multiple trauma with unstabilized fractures;
  • severe hemodynamic instability;
  • massive hemoptysis;
  • high risk of requiring CPR or defibrillation;

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 60-day mortality(After patients enrolled 60 days)

Study Sites (1)

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