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NCT Number: NCT04139733

Early Use of Prone Position in ECMO for Severe ARDS

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Prone positon

Procedure

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 positon

Procedure

Conventional supine position ventilation, no prone position.

Primary outcomes

  1. 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

  1. 60-day mortality

    Time frame: After patients enrolled 60 days

    Mortality rate at 60 days of VV-ECMO support

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2019
Registry last updated
Sep 19, 2024

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.

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