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Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasonic Cardiac Output Monitor (USCOM) system
Sponsored by
Santa Barbara Cottage Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Santa Barbara Cottage Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

USCOM

Arm Description

Outcomes

Primary Outcome Measures

Cardiac output measurement correlation at baseline
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)

Secondary Outcome Measures

Cardiac output measurement correlation after vasodilator testing
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing

Full Information

First Posted
October 27, 2016
Last Updated
March 8, 2022
Sponsor
Santa Barbara Cottage Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02951104
Brief Title
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Official Title
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Barbara Cottage Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
USCOM
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasonic Cardiac Output Monitor (USCOM) system
Primary Outcome Measure Information:
Title
Cardiac output measurement correlation at baseline
Description
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Cardiac output measurement correlation after vasodilator testing
Description
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States

12. IPD Sharing Statement

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Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

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