Back to resultsTranspulmonary Pressure in Right Ventricle Protection of ARDS
Primary Purpose
Acute Respiratory Distress Syndrome, Acute Cor Pulmonale
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mechanical ventilation strategy guided by transpulmonary pressure
Sponsored by
About this trial
This is an interventional prevention trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
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
Sites / Locations
- Beijing Chao-Yang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PTP group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Pulmonary vascular resistance (PVR)
PVR will measured by Swan-Ganz catheter
Pulmonary vascular compliance
Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.
Secondary Outcome Measures
Full Information
NCT ID
NCT05629832
First Posted
November 14, 2022
Last Updated
March 27, 2023
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05629832
Brief Title
Transpulmonary Pressure in Right Ventricle Protection of ARDS
Official Title
Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Cor Pulmonale
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PTP group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation strategy guided by transpulmonary pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary vascular resistance (PVR)
Description
PVR will measured by Swan-Ganz catheter
Time Frame
3 days
Title
Pulmonary vascular compliance
Description
Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Tang, MD
Phone
+86013811089795
Email
tangxiao0928@163.com
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Tang
Phone
+8613811089795
Email
tangxiao0928@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transpulmonary Pressure in Right Ventricle Protection of ARDS
We'll reach out to this number within 24 hrs