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

NCT07490925 | Recruiting DMC

• 1 other identifier: CYTS2025B20
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS (Moderate or Severe)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The respective incidence rates of ACP, RVF and RVD

  28 days

• ICU mortality

  28 days and 60 days

• invasive mechanical ventilation duration

  28 days

• the number of participants receiving vasoactive agents

  28 days

Study Arms (2)

Transpulmonary pressure group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Transpulmonary pressure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiao Tang, MD

CONTACT

86013811089795; tangxiao0928@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 24, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-03

Locations

CN (1)