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NCT Number: NCT07490925

Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With ARDS

To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.

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Key information

Conditions

ARDS (Moderate or Severe) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • ARDS caused by pneumonia (New Global Definition of ARDS)
  • PaO2/FiO2≤200mmHg
  • Received invasive mechanical ventilation
  • Sign the informed consent form

Exclusion criteria

  • Invasive mechanical ventilation duration > 48 hours
  • History of pulmonary hypertension caused by various reasons
  • Severe arrhythmia
  • BMI>30kg/m2
  • Contraindications to inserting an esophageal catheter (including recent esophageal injury or surgery, severe coagulopathy (platelets < 5×10⁹/L or INR > 4)
  • Pregnant and lactating women
  • Lung transplant recipient
  • High-risk factors for increased intracranial pressure (including intracranial hemorrhage, cerebral contusion, cerebral edema, intracranial space-occupying lesions, etc.)
  • Active air leakage in the lungs (pneumothorax, mediastinal emphysema, bronchopleural fistula, air leakage from closed thoracic drainage tubes, etc.)
  • Neuromuscular disease
  • Already received salvage measures (iNO, ECMO, prone position, high-frequency oscillatory ventilation)
  • Severe liver failure
  • Participated in other ARDS-related studies within 30 days

Treatment and study plan

Transpulmonary pressure guided mechanical ventilation strategy

Device

Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O.

In control group, PEEP was titrated using the low PEEP:FiO₂ table method.

Primary outcomes

  1. Incidence of right ventricular involvement within 28 days

    Time frame: 28 days

    Right ventricular involvement is defined as the presence of one of the following findings on transthoracic echocardiography:

    ACP: Right ventricular enlargement (RVED/LVED > 0.6) with paradoxical septal motion; RVF: Right ventricular enlargement (RVED/LVED > 0.6) accompanied by systemic venous congestion (CVP ≥ 8 mmHg), or if CVP is unavailable, inferior vena cava plethora; RVD: RV FAC < 35%, or TAPSE ≤ 16 mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Tang, MD

CONTACT

[email protected]

86013811089795

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Application of Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With Acute Respiratory Distress Syndrome Caused by Pneumonia

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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