Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Santa Barbara Cottage Hospital

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Device: Ultrasonic Cardiac Output Monitor (USCOM) system

Study type: Interventional

Funder types: Other

Identifiers

NCT02951104

16-61

Details and patient eligibility

About

Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

USCOM

Experimental group

Treatment:

Device: Ultrasonic Cardiac Output Monitor (USCOM) system