Early Use of Prone Position in ECMO for Severe ARDS

NCT ID: NCT04139733

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2024-09-15

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.

Conditions

Respiratory Distress Syndrome, Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Prone positon

Intervention Type: 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 group

1\. Supine group on ECMO.

Supine positon

Intervention Type: PROCEDURE

Conventional supine position ventilation, no prone position.

Interventions

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.

Intervention Type: PROCEDURE

Supine positon

Conventional supine position ventilation, no prone position.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rui Wang

Attending doctors

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Sun, Dr.

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Countries

China

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Other Identifiers

2019-KE-171

Identifier Type: -

Identifier Source: org_study_id