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

NCT ID: NCT05207202

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2023-07-20

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.

Conditions

Clinical Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EIT-PEEP strategy

Patients will receive PEEP titrated by EIT with a stepwise decrease PEEP trial

Group Type: ACTIVE_COMPARATOR

electrical impedance tomography

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

electrical impedance tomography

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Ling Liu

Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ling liu, phD

Role: STUDY_DIRECTOR

Southeast University, China

Locations

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 Municipality, 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

Countries

China

References

Yuan X, Zhang R, Wang Y, Chen D, Chao Y, Xu J, Guo L, Liu A, Xie J, Pan C, Yang Y, Qiu H, Liu L. Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial. Trials. 2023 Apr 11;24(1):266. doi: 10.1186/s13063-023-07280-6.

Reference Type: DERIVED

PMID: 37041561 (View on PubMed)

Other Identifiers

2021010065

Identifier Type: -

Identifier Source: org_study_id