Skip to content

Early Use of Prone Position in ECMO for Severe ARDS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04139733
Enrollment
160
Registered
2019-10-25
Start date
2019-11-01
Completion date
2024-09-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute respiratory distress syndrome, Extracorporeal Membrane Oxygenation, Prone Position

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.

Interventions

PROCEDUREProne 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.

PROCEDURESupine positon

Conventional supine position ventilation, no prone position.

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients successfully weaned from VV-ECMO,After patients enrolled 60 daysWeaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

Secondary

MeasureTime frameDescription
60-day mortalityAfter patients enrolled 60 daysMortality rate at 60 days of VV-ECMO support

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026