Effects of Low Tidal Volume and Airway Pressure Release Ventilation on Lung Tissue Mechanics in ARDS Patients Under Mechanical Ventilation: A Prospective Randomized Crossover Study

January 19, 2025 updated by: XiaoJing Zou,MD, Wuhan Union Hospital, China

The goal of this clinical trial is to learn how low tidal volume ventilation (LTV) and airway pressure release ventilation (APRV) affect lung tissue mechanics in adults with ARDS. The main questions it aims to answer are:

Does LTV or APRV improve lung tissue mechanics in patients with ARDS under mechanical ventilation? Researchers will compare LTV and APRV to see which ventilation mode works better for improving lung mechanics and patient safety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

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
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 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:

  1. Meets the diagnostic criteria of the 2023 Global New Definition of ARDS.
  2. Age: 18-80 years.
  3. PaO2/FiO2 ≤ 200.
  4. Within 12 hours of invasive mechanical ventilation treatment.
  5. Obtain consent from the patient or their family members to participate in the study, and sign the informed consent form.

Exclusion Criteria:

  1. Age < 18 years or > 80 years.
  2. Uncorrected shock of any type.
  3. Chronic obstructive pulmonary disease (COPD), pulmonary embolism, right heart failure, pulmonary hypertension, or severe arrhythmia.
  4. Contraindications for using Electrical Impedance Tomography (EIT) (extensive chest skin damage, infection, pacemaker implantation, implanted automatic defibrillator, etc.), pneumothorax, mediastinal emphysema, or large pleural effusion.
  5. Pregnant or breastfeeding women.
  6. Patients planned for ECMO treatment.
  7. Patients currently participating in or previously enrolled in other clinical studies.

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
Airway Pressure Release Ventilation (APRV)
Device: Airway Pressure Release Ventilation (APRV)
In this arm, participants will receive airway pressure release ventilation (APRV), a form of pressure-controlled mechanical ventilation. The high pressure (Phigh) is set based on the plateau pressure of the LTV mode, with a low pressure (Plow) set at 0 cmH₂O. The high pressure time (Thigh) will be set to 4-6 seconds to maintain alveolar recruitment, while the low pressure time (Tlow) will be set to 0.2-0.6 seconds to optimize expiratory flow. This arm aims to evaluate the effects of APRV on lung tissue mechanics, oxygenation, and overall respiratory function in ARDS patients.
No Intervention: Control group
Low tidal volume ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of low tidal volume vs airway pressure release ventilation on Dynamic relative regional lung strain（DRRS）
Time Frame: Maximum 4 hours
Maximum 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
mechanical power（MP）
Time Frame: Maximum 4 hours
Maximum 4 hours
platform pressure
Time Frame: Maximum 4 hours
Maximum 4 hours
mean airway pressure
Time Frame: Maximum 4 hours
Maximum 4 hours

Collaborators and Investigators

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

Sponsor

Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 20, 2024

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

November 20, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EITDRRS

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

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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