- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629832
Transpulmonary Pressure in Right Ventricle Protection of ARDS
March 16, 2026 updated by: Xiao Tang, Beijing Chao Yang Hospital
Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing Municipality
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Beijing, Beijing Municipality, China, 100020
- Beijing Chao-Yang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: PTP group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary vascular resistance (PVR)
Time Frame: 3 days
|
PVR will measured by Swan-Ganz catheter
|
3 days
|
|
Pulmonary vascular compliance
Time Frame: 3 days
|
Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 18, 2022
First Posted (Actual)
November 29, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ptp right ventricle protection
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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