NCT05003011

Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Respirix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodynamic Instability

Interventions

Type	Name	Description
DEVICE	Cardiospire	Non-invasive hemodynamic monitoring

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-03-15
• Completion: 2023-09-15
• First posted: 2021-08-12
• Last updated: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study