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Early Use of Prone Position in ECMO for Severe ARDS

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ClinicalTrials.gov Identifier: NCT04139733
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Rui Wang, Beijing Chao Yang Hospital

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
Respiratory Distress Syndrome, Adult Procedure: Prone positon Procedure: Supine positon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Prone group
  1. Prone position within 6 hours after randomization.
  2. 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.

Supine group
1. Supine group on ECMO.
Procedure: Supine positon
Conventional supine position ventilation, no prone position.




Primary Outcome Measures :
  1. VV-ECMO duration time [ Time Frame: After patients randomized grouping 30 days ]
    From VV-ECMO establishment to weaning


Secondary Outcome Measures :
  1. 60-day mortality [ Time Frame: After patients randomized grouping 60 days ]
    Mortality after patients randomized grouping 60 days



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139733


Contacts
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Contact: Rui Wang, Dr. +8618601342030 xuanben1985@163.com

Locations
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China, Beijing
Beijing Chao-Yang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Rui Wang, MD    +8618601342030    xuanben1985@163.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Bing Sun, Dr. Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
Publications:

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Responsible Party: Rui Wang, Attending doctors, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04139733    
Other Study ID Numbers: 2019-KE-171
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rui Wang, Beijing Chao Yang Hospital:
Acute respiratory distress syndrome
Extracorporeal Membrane Oxygenation
Prone Position
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury