Pulmonary Hypertension
Conditions
Brief summary
Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.
Interventions
DEVICEUltrasonic Cardiac Output Monitor (USCOM) system
Sponsors
Santa Barbara Cottage Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output measurement correlation at baseline | 30 minutes | Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output measurement correlation after vasodilator testing | 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 |
Countries
United States
Outcome results
None listed