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

NCT05207202 | Completed

• 1 other identifier: 2021010065
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 5

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.

Conditions

Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  mortality in Day 28

  at day 28

Secondary Outcomes (12)

• VFDs at day 28

  at day 28

• Shock-free days at day 28

  at day 28

• Length of ICU stay

  up to 24 months

• Length of hospital stay

  up to 24 months

• The rate of successful weaning

  at day 28

Other Outcomes (3)

• blood gas

  28 day

• vital signs

  28 day

• Ventilator parameters and respiratory mechanics

  28 day

Study Arms (2)

EIT-PEEP strategy

ACTIVE COMPARATOR

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

Device: electrical impedance tomography

ARDSNet-PEEP strategy

ACTIVE COMPARATOR

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

Interventions

electrical impedance tomography 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; EIT-PEEP strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (5)

the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine

Guangzhou, Guangdong, sonysang999@aliyun.com, China

Location

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210000, China

Location

Department of Critical Care Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Department of Critical Care Medicine, Zhongshan Hospital of Fudan University

Shangha, Shangha, 200032, China

Location

Department of ICU, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Related Publications (1)

• 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.

  PMID: 37041561 DERIVED

Study Officials

• ling liu, phD

  Southeast University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 26, 2022
• Study Start: February 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (5)