Hemodynamic Instability
Conditions
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.
Interventions
DEVICECardiospire
Non-invasive hemodynamic monitoring
Sponsors
Respirix, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeatable Data Verification | 3 months | First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS). |
| 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. |
Countries
United States
Contacts
Primary ContactCarin Lindquist
Outcome results
None listed