- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061669
Respiratory Monitoring During Right Heart
Respiratory Monitoring During Right Heart Catheterization to Differentiate Between Various Types of Pulmonary Hypertension; The Effects of the Cardiovascular System on the Lung Mechanical Properties
Study Overview
Status
Conditions
Detailed Description
Differentiation between different kinds of pulmonary hypertension (PHTN) requires right heart catheterization. Monitoring heart failure patients is challenging in many. The study will enroll patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and PHTN, based on the regular clinical practice. The regular indices as the right ventricle pressure (RVP), pulmonary artery pressure (PAP), pulmonary artery wedge pressure (PAWP), and cardiac output will be measured with the Swan Ganz Catheter and recorded.
Noninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask.
Non-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics.
Through evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yair Feld, MD
- Phone Number: +972-47772181
- Email: y_feld@rmc.gov.il
Study Locations
-
-
-
Haifa, Israel, 3109601
- Recruiting
- Rambam Medical Center
-
Contact:
- Yair Feld, MD
- Phone Number: +972-4-7772181
- Email: y_feld@rmc.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing right heart catheterization
Exclusion Criteria:
- Inability or unwillingness to follow or to sign the study protocol.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary artery pressure
Time Frame: only during the procedure of right heart catheterization
|
In mmHg measured by Swan-Ganz catheter
|
only during the procedure of right heart catheterization
|
Respiratory flow
Time Frame: only during the procedure of right heart catheterization
|
ml units
|
only during the procedure of right heart catheterization
|
Chest wall acceleration
Time Frame: only during the procedure of right heart catheterization
|
local tidal displacement
|
only during the procedure of right heart catheterization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Right ventricle pressure
Time Frame: only during the procedure of right heart catheterization
|
In mmHg measured by Swan-Ganz catheter
|
only during the procedure of right heart catheterization
|
Pulmonary artery wedge pressure
Time Frame: only during the procedure of right heart catheterization
|
In mmHg measured by Swan-Ganz catheter
|
only during the procedure of right heart catheterization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yair Feld, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0370-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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