NCT05207202

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Clinical Outcomes

Interventions

Type	Name	Description
DEVICE	electrical impedance tomography	PEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O and then reduced in steps of 2cmH2O from 20 to zero every 2min.

Timeline

• Start date: 2022-02-20
• Primary completion: 2023-07-20
• Completion: 2023-07-20
• First posted: 2022-01-26
• Last updated: 2025-03-20

Locations

5 sites across 1 country: China