Comparing low tidal volume and airway pressure release ventilation for ARDS patients

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

This study tests which breathing method, low tidal volume or airway pressure release ventilation, helps adults with Acute Respiratory Distress Syndrome breathe better and feel safer while on a ventilator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06790875 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of low tidal volume ventilation (LTV) and airway pressure release ventilation (APRV) on lung tissue mechanics in adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). The study will involve a prospective randomized crossover design, where participants will receive both ventilation methods to determine which one better improves lung mechanics and enhances patient safety. The trial will include patients who are within 12 hours of starting invasive mechanical ventilation and will assess their response to each ventilation mode.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who meet the diagnostic criteria for ARDS and require mechanical ventilation.

Not a fit: Patients with chronic respiratory conditions, severe arrhythmias, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved ventilation strategies that enhance lung function and safety for ARDS patients.

How similar studies have performed: Other studies have explored ventilation strategies in ARDS, but this specific comparison of LTV and APRV is novel.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaojing Zou Professor

Conditions ARDS; MP; DRRS