Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

Respirix

Status: Unknown

Conditions: Hemodynamic Instability

Treatments: Device: Cardiospire

Study type: Observational

Funder types: Industry

Identifiers

NCT05003011

CRD-02-1511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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