Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

NCT ID: NCT02951104

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-10-31

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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USCOM

Group Type EXPERIMENTAL

Ultrasonic Cardiac Output Monitor (USCOM) system

Intervention Type DEVICE

Interventions

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Ultrasonic Cardiac Output Monitor (USCOM) system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Barbara Cottage Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Countries

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United States

Other Identifiers

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16-61

Identifier Type: -

Identifier Source: org_study_id

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