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

Not Applicable

Completed

• Conditions: Clinical Outcomes
• Interventions: Device: electrical impedance tomography

• Registration Number: NCT05207202
• Lead Sponsor: Southeast University, China

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2022-02-20
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Age≥18 years
2. 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)
3. Diagnosis of ARDS less than 72 hours

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARDSNet-PEEP strategy	electrical impedance tomography	PEEP will be set according to the low FiO2-PEEP table to keep the oxygenation goals: SpO2 between 88% and 95%, and PaO2 between 55mmHg and 80mmHg.
EIT-PEEP strategy	electrical impedance tomography	Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial

Primary Outcome Measures

Name	Time	Method
28-day mortality	at day 28	mortality in Day 28

Secondary Outcome Measures

Name	Time	Method
Rate of pneumothorax	day 28	Rate of pneumothorax
Sequential Organ Failure Assessment (SOFA) score at the time of enrollment	at the time of enrollment	SOFA range from three to eight. The higher the score, the worse the prognosis
Shock-free days at day 28	at day 28	Shock-free days at day 28
number of shock and gastrointestinal hemorrhage	day 28	shock, and gastrointestinal hemorrhage
respiratory rate	up to 7 days	respiratory rate
VFDs at day 28	at day 28	defined as the number of days between successful weaning from MV and day 28 after study enrollment
Length of ICU stay	up to 24 months	the survival rate(survival/total) during ICU stay
Length of hospital stay	up to 24 months	the survival rate(survival/total) during hospital stay
The rate of successful weaning	at day 28	Proportion of people who are not dependent on ventilator ventilation
Proportion requiring rescue therapies	day 28	Proportion of people who require rescue therapies
driving pressure	day 0, day 1, day 2, day 3, day 7	measurement as one index of respiratory compliance at day 0, 1, 2, 3, and 7 from enrollment
Blood pressure at day D1, 2, 3, and 7 from enrollment	up to 24 months	Both systolic and diastolic pressure at day D1, 2, 3, and 7 from enrollment

Trial Locations

Locations (5)

the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine; 🇨🇳 Guangzhou, Guangdong, China

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University; 🇨🇳 Nanjing, Jiangsu, China

Department of Critical Care Medicine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

Department of Critical Care Medicine, Zhongshan Hospital of Fudan University; 🇨🇳 Shangha, Shangha, China

Department of ICU, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China