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Clinical Trials/NCT05307913
NCT05307913
Completed
Not Applicable

EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial

Peking Union Medical College Hospital1 site in 1 country676 target enrollmentApril 10, 2022

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2022
End Date
May 10, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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