Expiratory pressure for severe acute respiratory distress syndrome with V-V ECMO respiratory support trial

JRCT ID: jRCT1062220062

Registered date:05/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute respiratory distress syndrome
• Date of first enrollment: 05/10/2022
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Eligible participants were randomly assigned to the high PEEP group or low PEEP group.

High PEEP group
PEEP are set to 15 cm H2O from the start of V-V ECMO support until the liberation trial from V-V ECMO

Low PEEP group
PEEP are set to 5 cm H2O from the start of V-V ECMO support until the liberation trial from V-V ECMO

Other treatments are the same in the two groups.

Outcome(s)

• Primary Outcome: ECMO-free days during the first 28 days
• Secondary Outcome: mortality at 28 days, in-hospital mortality at 60 days, ventilator-free days during the first 60 days, length of ICU stay

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both
• Include criteria: Adult patients (18-80 years old) with ARDS requiring V-V ECMO

Exclude criteria

1. Had been converted from V-A ECMO
2. Had been on a ventilator for longer than 7 days
3. Hemodynamically unstable with LVEF below 40 percent
4. Pneumothorax or air leak syndrome
5. ARDS due to thoracic trauma
6. ARDS due to extra-pulmonary reason
7. Known pregnancy
8. Were judged by the ICU attending doctors as being unsuitable to participate in this study based on their medical condition

Related Information

• Primary Sponsor: Ohshimo Shinichiro
• Secondary Sponsor: Nishikimi Mitsuaki
• Source(s) of Monetary Support: JSPS