NCT05307913
Completed
Not Applicable
EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial
ConditionsARDS, Human
Overview
- Phase
- Not Applicable
- Intervention
- EIT-guided PEEP
- Conditions
- ARDS, Human
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 676
- Locations
- 1
- Primary Endpoint
- Survival in 28 days
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Exclusion Criteria
- •Age \< 18 years old and \> 90 years old;
- •EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
- •Severe intracranial hypertension;
- •Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
- •Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves)
- •End status of disease;
- •Patients or their families refused to participate in the study
Arms & Interventions
EIT-guided PEEP
PEEP titration by EIT
Intervention: EIT-guided PEEP
Table-guided PEEP
PEEP selection by the lower PEEP/FiO2 table
Intervention: Table-guided PEEP
Outcomes
Primary Outcomes
Survival in 28 days
Time Frame: 28 days
Survival within 28 days from randomization
Secondary Outcomes
- 28-day ventilator-free days(28 days)
- Lenght of hospital stay(Maximum 6-months)
- Lenght of ICU stay(Maximum 6-months)
- Barotrauma(7 days)
- ICU survival(Maximum 6-months)
- hospital survival(Maximum 6-months)
- change of Sequential Organ Failure Assessment (SOFA) score(2 days)
Study Sites (1)
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