Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study

NCT05922631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-18

No results posted yet for this study

Summary

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).

Conditions

  • Right Heart Failure
  • Mechanical Ventilation
  • Acute Respiratory Distress Syndrome

Interventions

PROCEDURE

Airway pressure release ventilation

ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.

PROCEDURE

low tidal volume

The ARDSnet method was used for LTV mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was \<30cmH2O

Sponsors & Collaborators

  • XiaoJing Zou,MD

    lead OTHER

Principal Investigators

  • Xiaojing zou, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2025-02-01
Completion
2025-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05922631 on ClinicalTrials.gov