Physiological Effects of Lung Impedance Tomography-Guided and Plat Pressure-Guided Phigh During APRV in Patients With ARDS

January 3, 2025 updated by: XiaoJing Zou,MD

Physiological Effects of Lung Impedance Tomography-guided and Plat Pressure-guided Phigh During Airway Pressure Release Ventilation in Patients With Acute Respiratory Distress Syndrome

This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 237000
        • Recruiting
        • Wuhan Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with ARDS according to the 2023 global new definition of ARDS.
  • Age ≥ 18 years.

Exclusion Criteria:

  • Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bullae, pneumothorax, subcutaneous emphysema, mediastinal emphysema, etc. · Contraindications for EIT, such as chest wound dressing, pacemaker implantation, defibrillator use, etc.
  • Pulmonary interstitial disease.
  • Uncorrected shock of various types.
  • Intracranial hypertension.
  • Pregnant and postpartum women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
EIT-guided Phigh settings during APRV
Device: EIT-guided Phigh settings during APRV
The Phigh level selected for the patients in the Intervention group was the intercept point of cumulated collapse and overdistension percentage curves, providing the best compromise between collapsed and overdistended lung.
No Intervention: Control group
Pplat-guided Phigh settings during APRV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effects of Phigh guided by different methods on regional lung ventilation assessed by EIT
Time Frame: 1 Hour Post-Intervention
1 Hour Post-Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global inhomogeneity assessed by electrical impedance tomography
Time Frame: 1 Hour Post-Intervention
1 Hour Post-Intervention
Center of ventilation assessed by electrical impedance tomography
Time Frame: 1 Hour Post-Intervention
1 Hour Post-Intervention
ventilation/perfusion matching assessed by EIT
Time Frame: 1 Hour Post-Intervention
1 Hour Post-Intervention
Respiratory system compliance
Time Frame: 1 Hour Post-Intervention
Tidal volume divided by plateau pressure
1 Hour Post-Intervention
mean arterial pressure
Time Frame: 1 Hour Post-Intervention
1 Hour Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XiaoJing Zou,MD

Collaborators

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 16, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APRVPhigh2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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