Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951104
• Other study ID #: 16-61
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: October 2021

Study information

• Verified date: March 2022
• Source: Santa Barbara Cottage Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Ultrasonic Cardiac Output Monitor (USCOM) system

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 minutes
Secondary	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	30 minutes