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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS (Moderate or Severe)
• Intervention / Treatment: Device: Transpulmonary pressure guided mechanical ventilation strategy

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao Tang, MD; Phone Number: 86013811089795; Email: tangxiao0928@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpulmonary pressure group; 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.	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.
No Intervention: Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of right ventricular involvement within 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.	28 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular
• Other Study ID Numbers: CYTS2025B20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No