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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06790875
Enrollment
15
Registered
2025-01-24
Start date
2024-11-20
Completion date
2025-11-20
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS, MP, DRRS

Brief 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.

Interventions

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.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

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.

Design outcomes

Primary

MeasureTime frame
Impact of low tidal volume vs airway pressure release ventilation on Dynamic relative regional lung strain(DRRS)Maximum 4 hours

Secondary

MeasureTime frame
mechanical power(MP)Maximum 4 hours
platform pressureMaximum 4 hours
mean airway pressureMaximum 4 hours

Countries

China

Contacts

Primary ContactXiaojing Zou Professor
13995518630@163.com13995518630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026