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Completed

NCT Number: NCT05307913

PET - PEEP by EIT for Acute Respiratory Distress Syndrome 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

Treatment and study plan

EIT-guided PEEP

Other

PEEP setting according to EIT

Table-guided PEEP

Other

PEEP setting according to the lower PEEP/FiO2 table

Primary outcomes

  1. Survival in 28 days

    Time frame: 28 days

    Survival within 28 days from randomization

Secondary outcomes

  1. Lenght of ICU stay

    Time frame: Maximum 6-months

    Length of hospital stay from randomization to ICU discharge

  2. Lenght of hospital stay

    Time frame: Maximum 6-months

    Length of hospital stay from randomization to hospital discharge

  3. 28-day ventilator-free days

    Time frame: 28 days

    Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.

  4. Barotrauma

    Time frame: 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.

  5. ICU survival

    Time frame: Maximum 6-months

    Survival at ICU discharge.

  6. hospital survival

    Time frame: Maximum 6-months

    Survival at hospital discharge.

  7. change of Sequential Organ Failure Assessment (SOFA) score

    Time frame: 2 days

    change of SOFA score within first 2 days

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2022
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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