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Recruiting NCT06790875

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

No phase Interventional ARDS (Acute Respiratory Distress Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Airway Pressure Release Ventilation (APRV).
Who it may be relevant to
Registry conditions: ARDS (Acute Respiratory Distress Syndrome). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Impact of low tidal volume vs airway pressure release ventilation on Dynamic relative regional lung strain（DRRS） [Time frame: Maximum 4 hours]
Secondary outcome measures (3)
  • mechanical power（MP） [Time frame: Maximum 4 hours]
  • platform pressure [Time frame: Maximum 4 hours]
  • mean airway pressure [Time frame: Maximum 4 hours]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years or > 80 years.
  • Uncorrected shock of any type.
  • Chronic obstructive pulmonary disease (COPD), pulmonary embolism, right heart failure, pulmonary hypertension, or severe arrhythmia.
  • 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.
  • Pregnant or breastfeeding women.
  • Patients planned for ECMO treatment.
  • Patients currently participating in or previously enrolled in other clinical studies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

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. PMID 21297069

Identifiers

NCT: NCT06790875 · EITDRRS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗