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Early Use of Prone Position in ECMO for Severe ARDS

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04139733
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Extracorporeal membrane oxygenation (ECMO) is widely used in the salvage treatment of critical acute respiratory distress syndrome (ARDS). However, reduce lung injury, accelerate lung recovery, shorten VV-ECMO support time and decrease complications during the treatment needs further study. By changing the body position of ARDS patients, prone position can increase the dorsal ventilation of the lung and improve the ventilation/blood flow ratio of the lung, so as to improve oxygenation. Previous multicenter studies have proved that prone position can significantly reduce the mortality of patients with moderate and severe ARDS. However, patients with severe ARDS rescue by VV-ECMO is rarely combined with prone position. On the one hand, with the support of ECMO, the patients oxygenation will be significantly improved, and they will no longer need the assist of prone position. On the other hand, ECMO cannula brings some challenges to the implementation of prone position. At present, only a few cohort studies have reported that VV-ECMO combined with prone position could improve the oxygenation index and respiratory system compliance during the late period of treatment. This study aims to evaluate whether early prone position could reduce VV-ECMO duration time, so as to reduce the occurrence of ECMO-related complications, which may ultimately affect the prognosis of ARDS patients treated by ECMO.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Prone positon
  • Procedure: Supine positon
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Early Use of Prone Position in Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prone group

Prone position within 6 hours after randomization. Prone position for at least conservative hours per days during a minimum of 5 days.

Procedure: Prone positon
Prone position within 6 hours after randomization. Prone position for at least conservative hours per days during a minimum of 5 days.
Other: Supine group

1. Supine group on ECMO.

Procedure: Supine positon
Conventional supine position ventilation, no prone position.

Outcome Measures

Primary Outcome Measures

  1. VV-ECMO duration time [After patients randomized grouping 30 days]

    From VV-ECMO establishment to weaning

Secondary Outcome Measures

  1. 60-day mortality [After patients randomized grouping 60 days]

    Mortality after patients randomized grouping 60 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. met the diagnostic criteria of Berlin definition for ARDS;

  2. the cause of ARDS was determined as pneumonia；

  3. patients had one of following criteria despite optimum mechanical ventilation (tidal volume 6ml/kg of PBM, PEEP≥10cmH2O, and FiO2≥0.8) and use of various rescue therapies (corticosteroids, recruitment maneuvers, prone position, neuromuscular blockade, and high-frequency oscillatory ventilation): ratio of partial pressure of arterial oxygen (PaO2) to FiO2≤80 mm Hg, or an arterial blood pH <7.20 with a partial pressure of arterial carbon dioxide (PaCO2)>60mmHg, with respiratory rate increased to 35 breaths/min and keep a Pplat≤30cmH2O.

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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao-Yang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rui Wang, Attending doctors, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT04139733
Other Study ID Numbers:
  • 2019-KE-171
First Posted:
Oct 25, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rui Wang, Attending doctors, Beijing Chao Yang Hospital
Acute respiratory distress syndrome
Extracorporeal Membrane Oxygenation
Prone Position
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome

Study Results

No Results Posted as of Jul 21, 2021