Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

• Sponsor: Santa Barbara Cottage Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02951104
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Device: Ultrasonic Cardiac Output Monitor (USCOM) system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: USCOM	Device: Ultrasonic Cardiac Output Monitor (USCOM) system

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105

Sponsors and Collaborators

• Santa Barbara Cottage Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santa Barbara Cottage Hospital
• ClinicalTrials.gov Identifier: NCT02951104
• Other Study ID Numbers: 16-61
• First Posted: Nov 1, 2016
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Hypertension, Pulmonary; Hypertension

Study Results

No Results Posted as of Mar 10, 2022