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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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ARDS (Acute Respiratory Distress Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Airway Pressure Release Ventilation (APRV)

Group Type EXPERIMENTAL

Airway Pressure Release Ventilation (APRV)

Intervention Type DEVICE

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.

Control group

Low tidal volume ventilation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No