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RecruitingNCT06790875Updated Jan 24, 2025

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

An interventional study of Airway Pressure Release Ventilation (APRV) in ARDS (Acute Respiratory Distress Syndrome), sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by Wuhan Union Hospital, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • ARDS (Acute Respiratory Distress Syndrome)

Keywords

  • ARDS
  • MP
  • DRRS
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Airway Pressure Release Ventilation (APRV)

    Device: Airway Pressure Release Ventilation (APRV)

  • No intervention
    Control group

    Low tidal volume ventilation

Interventions

  • DeviceAirway 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.

06

What researchers measure

Primary outcomes

  1. Impact of low tidal volume vs airway pressure release ventilation on Dynamic relative regional lung strain（DRRS）

    Time frame: Maximum 4 hours

Secondary outcomes

  1. mechanical power（MP）

    Time frame: Maximum 4 hours

  2. platform pressure

    Time frame: Maximum 4 hours

  3. mean airway pressure

    Time frame: Maximum 4 hours

07

Study locations

1 of 1 sites recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
08

References and documents

Publications

  • Protti A, Cressoni M, Santini A, Langer T, Mietto C, Febres D, Chierichetti M, Coppola S, Conte G, Gatti S, Leopardi O, Masson S, Lombardi L, Lazzerini M, Rampoldi E, Cadringher P, Gattinoni L. Lung stress and strain during mechanical ventilation: any safe threshold? Am J Respir Crit Care Med. 2011 May 15;183(10):1354-62. doi: 10.1164/rccm.201010-1757OC. Epub 2011 Feb 4. Erratum In: Am J Respir Crit Care Med. 2012 Jan 1;185(1):115. PubMed 21297069 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06790875
Lead sponsor
Wuhan Union Hospital, China
Responsible party
XiaoJing Zou,MD (Principal Investigator, Wuhan Union Hospital, China) — Principal investigator
First posted
Jan 24, 2025
Start date
Nov 20, 2024
Primary completion
Nov 20, 2025 (estimated)
Completion
Nov 20, 2025 (estimated)
Last update
Jan 24, 2025

Study contacts

Xiaojing Zou Professor
Contact
13995518630@163.com
13995518630

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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