PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

NCT05307913 | Completed DMC

• 1 other identifier: PEEP by EIT for ARDS
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human

Keywords

electrical impedance tomography; ARDS; PEEP

Outcome Measures

Primary Outcomes (1)

• Survival in 28 days

  Survival within 28 days from randomization

  28 days

Secondary Outcomes (7)

• Lenght of ICU stay

  Maximum 6-months

• Lenght of hospital stay

  Maximum 6-months

• 28-day ventilator-free days

  28 days

• Barotrauma

  7 days

• ICU survival

  Maximum 6-months

Study Arms (2)

EIT-guided PEEP

EXPERIMENTAL

PEEP titration by EIT

Other: EIT-guided PEEP

Table-guided PEEP

ACTIVE COMPARATOR

PEEP selection by the lower PEEP/FiO2 table

Other: Table-guided PEEP

Interventions

EIT-guided PEEP OTHER

PEEP setting according to EIT

EIT-guided PEEP

Table-guided PEEP OTHER

PEEP setting according to the lower PEEP/FiO2 table

Table-guided PEEP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age \< 18 years old and \> 90 years old;
• Pregnancy;
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• Sanchez-Piedra C, Rodriguez-Ortiz-de-Salazar B, Roca O, Prado-Galbarro FJ, Perestelo-Perez L, Sanchez-Gomez LM. Electrical impedance tomography for PEEP titration in ARDS patients: a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):987-997. doi: 10.1007/s10877-025-01266-2. Epub 2025 Feb 26.

  PMID: 40011398 DERIVED

• 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.

  PMID: 38307528 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: April 1, 2022
• Study Start: April 10, 2022
• Primary Completion: February 27, 2025
• Study Completion: May 10, 2025
• Last Updated: January 29, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)