Effect of Electric Impedance Tomography-Guided PEEP Titration

NCT05736185 | Completed

• 1 other identifier: EIT-PEEPstudy
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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, how to best set PEEP 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 ventilation-perfusion mismatch.

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP

  EIT-PEEP was obtained by EIT, low-PEEP was obtained by low FIO2-PEEP table, and high-PEEP was obtained by high FIO2-PEEP table.

  up to 24 hours

Secondary Outcomes (12)

• difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP

  up to 24 hours

• Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP

  up to 24 hours

• Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP

  up to 24 hours

• Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP

  up to 24 hours

• Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP

  up to 24 hours

Study Arms (3)

EIT-PEEP strategy

EXPERIMENTAL

PEEP selected by EIT which remained at 15 min

Device: PEEP selection

Low FiO2-PEEP strategy

EXPERIMENTAL

PEEP selected by low FiO2-PEEP table which remained at 15 min

Device: PEEP selection

High FiO2-PEEP strategy

EXPERIMENTAL

PEEP selected by high FiO2-PEEP table which remained at 15 min

Device: PEEP selection

Interventions

PEEP selection DEVICE

Electric impedance tomography-guided PEEP titration

EIT-PEEP strategy; High FiO2-PEEP strategy; Low FiO2-PEEP strategy

Eligibility Criteria

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

You may qualify if:

• Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
• undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset

You may not qualify if:

• age \<18 years old
• patient undergoing legal protection
• contra-indications to EIT (e. g. severe chest trauma or wounds)
• pneumothorax
• patient undergoing ECMO
• pregnancy

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• liu ling, phD

  Zhongda Hospital, School of Medicine, Southeast University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 25, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)