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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Treatments: Device: Airway Pressure Release Ventilation (APRV)

Study type: Interventional

Funder types: Other

Identifiers

NCT06790875

EITDRRS

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Intervention group

Experimental group

Description:

Airway Pressure Release Ventilation (APRV)

Treatment:

Device: Airway Pressure Release Ventilation (APRV)

Control group

No Intervention group

Description:

Low tidal volume ventilation