Early Use of Prone Position in ECMO for Severe ARDS

Recruiting

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Procedure: Prone positon; Procedure: Supine positon

• Registration Number: NCT04139733
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2019-11-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prone group	Prone positon	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.
Supine group	Supine positon	1. Supine group on ECMO.

Primary Outcome Measures

Name	Time	Method
The proportion of patients successfully weaned from VV-ECMO,	After patients enrolled 60 days	Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

Secondary Outcome Measures

Name	Time	Method
60-day mortality	After patients enrolled 60 days	Mortality rate at 60 days of VV-ECMO support

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China