Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

• Sponsor: Respirix, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05003011
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Device: Cardiospire

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
• Anticipated Study Start Date: Sep 15, 2021
• Anticipated Primary Completion Date: Mar 15, 2023
• Anticipated Study Completion Date: Sep 15, 2023

Outcome Measures

Primary Outcome Measures

1. Repeatable Data Verification [3 months]

   First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• Respirix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Respirix, Inc.
• ClinicalTrials.gov Identifier: NCT05003011
• Other Study ID Numbers: CRD-02-1511
• First Posted: Aug 12, 2021
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Aug 12, 2021