PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

Not Applicable

Recruiting

• Conditions: ARDS, Human
• Interventions: Other: EIT-guided PEEP; Other: Table-guided PEEP

• Registration Number: NCT05307913
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-03-30
• Status Verified: 2022-04
• Study First Posted: 2022-04-01
• Study Start: 2022-04-10
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor

Exclusion Criteria

1. Age < 18 years old and > 90 years old;
2. Pregnancy;
3. EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
4. Severe intracranial hypertension;
5. Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
6. 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)
7. End status of disease;
8. Patients or their families refused to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EIT-guided PEEP	EIT-guided PEEP	PEEP titration by EIT
Table-guided PEEP	Table-guided PEEP	PEEP selection by the lower PEEP/FiO2 table

Primary Outcome Measures

Name	Time	Method
Survival in 28 days	28 days	Survival within 28 days from randomization

Secondary Outcome Measures

Name	Time	Method
28-day ventilator-free days	28 days	Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
Lenght of hospital stay	Maximum 6-months	Length of hospital stay from randomization to hospital discharge
Lenght of ICU stay	Maximum 6-months	Length of hospital stay from randomization to ICU discharge
Barotrauma	7 days	We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.
ICU survival	Maximum 6-months	Survival at ICU discharge.
hospital survival	Maximum 6-months	Survival at hospital discharge.
change of Sequential Organ Failure Assessment (SOFA) score	2 days	change of SOFA score within first 2 days

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China