PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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ARDS, Human

Intervention / Treatment
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* Other: EIT-guided PEEP
* Other: Table-guided PEEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical impedance tomography, ARDS, PEEP