Effect of Electric Impedance Tomography-Guided PEEP Titration

NCT ID: NCT05736185

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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EIT-PEEP strategy

PEEP selected by EIT which remained at 15 min

Group Type EXPERIMENTAL

PEEP selection

Intervention Type DEVICE

Electric impedance tomography-guided PEEP titration

Low FiO2-PEEP strategy

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

Group Type EXPERIMENTAL

PEEP selection

Intervention Type DEVICE

Electric impedance tomography-guided PEEP titration

High FiO2-PEEP strategy

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

Group Type EXPERIMENTAL

PEEP selection

Intervention Type DEVICE

Electric impedance tomography-guided PEEP titration

Interventions

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PEEP selection

Electric impedance tomography-guided PEEP titration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. age \<18 years old
2. patient undergoing legal protection
3. contra-indications to EIT (e. g. severe chest trauma or wounds)
4. pneumothorax
5. patient undergoing ECMO
6. pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Ling Liu

Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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liu ling, phD

Role: STUDY_DIRECTOR

Zhongda Hospital, School of Medicine, Southeast University

Locations

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Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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EIT-PEEPstudy

Identifier Type: -

Identifier Source: org_study_id

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