PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

Peking Union Medical College Hospital676 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

676

Conditions

ARDS, Human

Interventions

EIT-guided PEEPOTHER

PEEP setting according to EIT

Table-guided PEEPOTHER

PEEP setting according to the lower PEEP/FiO2 table

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Survival in 28 days

Survival within 28 days from randomization

Time frame: 28 days

Secondary Outcomes

Lenght of ICU stay

Length of hospital stay from randomization to ICU discharge

Time frame: Maximum 6-months

Lenght of hospital stay

Length of hospital stay from randomization to hospital discharge

Time frame: Maximum 6-months

28-day ventilator-free days

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

Time frame: 28 days

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.

Time frame: 7 days

ICU survival

Survival at ICU discharge.

Time frame: Maximum 6-months

hospital survival

Survival at hospital discharge.

Time frame: Maximum 6-months

change of Sequential Organ Failure Assessment (SOFA) score

change of SOFA score within first 2 days

Time frame: 2 days

Data from ClinicalTrials.gov

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