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Not yet recruiting NCT07490925

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

No phase Interventional ARDS (Moderate or Severe)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transpulmonary pressure guided mechanical ventilation strategy.
Who it may be relevant to
Registry conditions: ARDS (Moderate or Severe). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Transpulmonary pressure guided mechanical ventilation strategy
    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 outcome measures

  • Incidence of right ventricular involvement within 28 days [Time frame: 28 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07490925 · CYTS2025B20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗