Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
- Conditions
- Hemodynamic Instability
- Registration Number
- NCT05003011
- Lead Sponsor
- Respirix, Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- ≥ 18 years of age
- Intubated
- Pulmonary artery catheter
- Patient or patient's legally authorized representative is able to provide informed consent
- Subjects who, at the principal investigator's determination, would not be appropriate for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation and Validation of data 1.5 years Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes.
Repeatable Data Verification 3 months First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States