PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

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

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.

Study Overview

• Status: Completed
• Conditions: ARDS, Human
• Intervention / Treatment: Other: EIT-guided PEEP; Other: Table-guided PEEP

• Study Type: Interventional
• Enrollment (Actual): 676
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EIT-guided PEEP; PEEP titration by EIT	Other: EIT-guided PEEP; PEEP setting according to EIT
Active Comparator: Table-guided PEEP; PEEP selection by the lower PEEP/FiO2 table	Other: Table-guided PEEP; PEEP setting according to the lower PEEP/FiO2 table

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival in 28 days	Survival within 28 days from randomization	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of ICU stay	Length of hospital stay from randomization to ICU discharge	Maximum 6-months
Barotrauma	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.	7 days
ICU survival	Survival at ICU discharge.	Maximum 6-months
Lenght of hospital stay	Length of hospital stay from randomization to hospital discharge	Maximum 6-months
28-day ventilator-free days	Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.	28 days
hospital survival	Survival at hospital discharge.	Maximum 6-months
change of Sequential Organ Failure Assessment (SOFA) score	change of SOFA score within first 2 days	2 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Wong H, Chi Y, Zhang R, Yin C, Jia J, Wang B, Liu Y, Shang Y, Wang R, Long Y, Zhao Z, He H. Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol. BMJ Open. 2024 Feb 1;14(2):e080828. doi: 10.1136/bmjopen-2023-080828.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): May 10, 2025

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ARDS; PEEP; electrical impedance tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: PEEP by EIT for ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No