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NCT05003011 Clinical Trial

Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

Hemodynamic Instability Clinical Trial

Official title:
Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05003011
Other study ID # CRD-02-1511
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2021
Est. completion date September 15, 2023

Study information
Verified date August 2021
Source Respirix, Inc.
Contact Carin Lindquist
Phone 4159268616
Email clindquist@theranova.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed as an observational study to collect Cardiospire cardiogenic oscillation signal (COS) and CO output parameters from the Pulmonary Artery Catheter in intubated patients.

Description:

Respirix has developed a non-invasive hemodynamic monitoring device called the Cardiospire. The Cardiospire detects minor, cyclic waveforms caused by Cardiogenic Oscillations (COS) and uses features of the COS waveform to provide information about hemodynamics. This study is designed as an observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date September 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - = 18 years of age - Intubated - Pulmonary artery catheter - Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: - Subjects who, at the principal investigator's determination, would not be appropriate for this study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cardiospire
Non-invasive hemodynamic monitoring

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
Respirix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Repeatable Data Verification First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS). 3 months
Primary Correlation and Validation of data Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes. 1.5 years
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