Effect of EIT-guided PEEP Titration on the Prognosis of Patients With Moderate to Severe ARDS

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    376
  • sponsor
    Southeast University, China
Updated on 27 July 2022

Summary

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes.

Description

This is a prospective, multicenter, single-blind, parallel-group, adaptive randomized controlled trial (RCT) with intention-to-treat analysis which aims to determine the effects of PEEP setting guided by EIT on the clinical outcomes for moderate or severe ARDS patients ventilated with lung protective ventilation strategy. Adult patients with moderate to severe ARDS less than 72 hours after diagnosis will be included in this study. Patients in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas patients in the control group will select PEEP based on the FiO2-PEEP table. Other ventilator parameters will be set according to the ARDSnet strategy. The primary outcome is 28-day mortality. The secondary outcomes include ventilator-free days and shock-free days at day 28, length of ICU and hospital stay, the rate of successful weaning, proportion requiring rescue therapies, compilations, respiratory variables, and Sequential Organ Failure Assessment (SOFA). This study will also perform the interim analysis and subgroup analysis.

Details
Condition Clinical Outcomes
Treatment Electrical Impedance Tomography
Clinical Study IdentifierNCT05207202
SponsorSoutheast University, China
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age≥18 years
Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen [PaO2]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
Diagnosis of ARDS less than 72 hours

Exclusion Criteria

Expected to be mechanically ventilated for less than 48 hours
Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
Undrained pneumothorax or subcutaneous emphysema
Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
Severe neuromuscular disease
Hemodynamic instability
Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
Severe other organs dysfunction with a low expected survival (7 days) or palliative care
Solid organ or hematologic tumors with the expected survival time less than 30 days
Participating in other clinical trials within 30 days
Pregnancy
Refusal to sign the informed consent
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