Transpulmonary Pressure in Right Ventricle Protection of ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629832
• Other study ID #: Ptp right ventricle protection
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Beijing Chao Yang Hospital
• Contact: Xiao Tang, MD
• Phone: +86013811089795
• Email: tangxiao0928[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• duration of invasive mechanical ventilation less than 72 hours;
• meet the diagnostic criteria of Berlin definition for ARDS;
• age older than 18

Exclusion Criteria:

• esophageal surgery or damage;
• cardiac surgery;
• severe bronchopleural fistula;
• serious arrhythmia; pneumothorax;
• tricuspid stenosis;
• heparin allergy;
• chronic pulmonary heart disease

Related Conditions & MeSH terms

• Acute Cor Pulmonale
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Pulmonary Heart Disease
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• mechanical ventilation strategy guided by transpulmonary pressure
Mechanical ventilation parameters adjust guided by transpulmonary pressure monitoring. For pressure assist control or volumn assit control mode; inspiratory pressure or volumn setting needs to maintain Ppeak less than 25 cm H2O; PEEP was set at such a level that expiratory Ptp stayed between 0 and 5 cm H2O.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary vascular resistance (PVR)	PVR will measured by Swan-Ganz catheter	3 days
Primary	Pulmonary vascular compliance	Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.	3 days