NCT05922631Completed
Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study
Effect of Airway Pressure Release Ventilation vs. Low Tidal Volume Ventilation on Right Heart Function in Acute Respiratory Distress Syndrome Patients: a Single-center Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
Acute Respiratory Distress Syndrome (ARDS) is often complicated by Right Ventricular Dysfunction (RVD), and the incidence can be as high as 64%. The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction. Pulmonary vascular dysfunction includes acute vascular inflammation, pulmonary vascular edema, thrombosis and pulmonary vascular remodeling. Alveolar collapse and over distension can also lead to increased pulmonary vascular resistance, Preventing the development of acute cor pulmonale in patients with acute respiratory distress. ARDS patients with RVD have a worse prognosis and a significantly increased risk of death, which is an independent risk factor for death in ARDS patients. Therefore, implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD. APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure, which can effectively improve oxygenation and reduce ventilator-associated lung injury. However, its effect on right ventricular function is still controversial. Low tidal volume (LTV) is a mechanical ventilation strategy widely used in ARDS patients. Meta-analysis results showed that compared with LTV, APRV improved oxygenation more significantly, reduced the time of mechanical ventilation, and even had a tendency to improve the mortality of ARDS patients However, randomized controlled studies have shown that compared with LTV, APRV improves oxygenation more significantly and also increases the mean airway pressure. Therefore, some scholars speculate that APRV may increase the intrathoracic pressure, pulmonary circulatory resistance, and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence. In addition, APRV may improve right ventricular function by correcting hypoxia and hypercapnia, promoting lung recruitment and reducing pulmonary circulation resistance. Therefore, it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic.we aim to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS, pulmonary circulatory resistance (PVR) right ventricular-pulmonary artery coupling (RV-PA coupling), and pulmonary vascular resistance (PVR).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 19 Jun 2023
- Start date
- Jul 2023
- Primary completion date
- Feb 2025
- Lead sponsor
- XiaoJing Zou,MD
- Diseases
- Heart failure
- NCT number
- NCT05922631
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From Jul 2023 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1.abdominal pressure≥20mmHg 2.BMI≥35kg/m2; 3. pregnant and lactating women 4.expected duration of invasive mechanical ventilation \< 72 hours 5. neuromuscular diseases known to require prolonged mechanical ventilation 6.severe chronic obstructive pulmonary disease, severe asthma, Interstitial lung disease 7.intracranial hypertension, 8.pulmonary bullae or pneumothorax, subcutaneous emphysema, or mediastinal emphysema, 9.extracorporeal membrane oxygenation or prone position ventilation on admission to the ICU 10. uncorrected shock of various types and refractory shock 11.pulmonary embolism 12.severe cardiac dysfunction (New York Heart Association class III or IV). Acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary diseases, cardiogenic shock or after major cardiac surgery 13.poor cardiac sound window, unable to obtain cardiac ultrasound images 14.no informed consent was signed
Who the study is looking for
- 1\. Patients who meet the 2012 Berlin ARDS diagnostic criteria and perform invasive mechanical ventilation 2, PEEP≥5cmH2O, oxygenation index ≤200mmHg 3. Tracheal intubation and mechanical ventilation were performed for less than 48h at the time of inclusion 4. Age ≥18 years and ≤80 years
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.