Clinical trial NCT04139733: Early Use of Prone Position in ECMO for Severe ARDS
Official title: Early Use of Prone Position in Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Acute respiratory distress syndrome
Extracorporeal Membrane Oxygenation
Prone Position
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone PP as rescue therapy before VV-ECMO

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.


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;

Primary outcomes:
measure: The proportion of patients successfully weaned from VV-ECMO,
timeFrame: After patients enrolled 60 days
Secondary outcomes:
measure: 60-day mortality
timeFrame: After patients enrolled 60 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
name: Bing Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
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