PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2025-05-10

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.

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Detailed Description

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Conditions

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ARDS, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EIT-guided PEEP

PEEP titration by EIT

Group Type EXPERIMENTAL

EIT-guided PEEP

Intervention Type OTHER

PEEP setting according to EIT

Table-guided PEEP

PEEP selection by the lower PEEP/FiO2 table

Group Type ACTIVE_COMPARATOR

Table-guided PEEP

Intervention Type OTHER

PEEP setting according to the lower PEEP/FiO2 table

Interventions

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EIT-guided PEEP

PEEP setting according to EIT

Intervention Type OTHER

Table-guided PEEP

PEEP setting according to the lower PEEP/FiO2 table

Intervention Type OTHER

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No