- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951104
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
March 8, 2022 updated by: Santa Barbara Cottage Hospital
Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
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
-
-
California
-
Santa Barbara, California, United States, 93105
- Santa Barbara Cottage 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
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age > 18 years
- Diagnosis of Group 1 or Group 4 PAH based on PAPm > 25 mmHg, PAWP <15 mmHg, PVR >3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
- Willingness and ability to comply with study procedures.
- No known hypersensitivity to the components of USCOM electrodes
Exclusion criteria:
- Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
- Evidence of postcapillary pulmonary hypertension on right heart catheterization
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: USCOM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output measurement correlation at baseline
Time Frame: 30 minutes
|
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output measurement correlation after vasodilator testing
Time Frame: 30 minutes
|
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing
|
30 minutes
|
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)
November 1, 2016
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
October 27, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (Estimate)
November 1, 2016
Study Record Updates
Last Update Posted (Actual)
March 10, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-61
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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