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

Capital Medical University

Status: Not yet enrolling

Conditions: ARDS (Moderate or Severe)

Treatments: Device: Transpulmonary pressure guided mechanical ventilation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT07490925

CYTS2025B20

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Transpulmonary pressure group

Experimental group

Description:

The overall concept of this group is to individualize PEEP. After enrollment, all patients underwent placement of an gastric tube for esophageal pressure monitoring.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. FiO₂ is titrated to keep the patient's SpO₂ at 90%-95%. Respiratory rate is adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg. If end-inspiratory transpulmonary pressure exceeds 20 cmH₂O, tidal volume may be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume may be increased up to 8 mL/kg PBW provided that end-inspiratory transpulmonary pressure remains ≤ 20 cmH₂O.

Treatment:

Device: Transpulmonary pressure guided mechanical ventilation strategy

Control group

No Intervention group

Description:

In this group, PEEP was titrated using the low PEEP:FiO₂ table method. Volume-assist control (V-A/C) ventilation was adopted, with tidal volume maintained at approximately 6 mL/kg predicted body weight (PBW) and plateau pressure controlled at ≤ 30 cmH₂O. PEEP was adjusted to maintain the oxygenation target of SpO₂ 90%-95% while using the lowest possible PEEP:FiO₂ combination in the table. Respiratory rate was adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg. Esophageal pressure monitoring was simultaneously performed in this group to calculate and record end-inspiratory and end-expiratory transpulmonary pressures; however, ventilator parameters were not adjusted based on these measurements, and crossover to the transpulmonary pressure (Ptp) group was not permitted. If plateau pressure exceeded 30 cmH₂O, tidal volume could be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume could be increased up to 8 mL/kg PBW