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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Outcomes
• Intervention / Treatment: Device: electrical impedance tomography

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, sonysang999@aliyun.com
      • the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
  • Shangha
    • Shangha, Shangha, China, 200032
      • Department of Critical Care Medicine, Zhongshan Hospital of Fudan University
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Department of Critical Care Medicine, Renji Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Department of ICU, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EIT-PEEP strategy; Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial	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.
Active Comparator: ARDSNet-PEEP strategy; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	mortality in Day 28	at day 28

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood gas	blood gas and the change at each time point	28 day
vital signs	HR, MAP, RR, SPO2, CVP, CO and so on at each time point	28 day
Ventilator parameters and respiratory mechanics	VT, RR, PEEP, FiO2, compliance, resistance and so on	28 day

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: ling liu, phD, Southeast University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021010065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No