NCT04255108

Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

Detailed description

This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.

Conditions

• Cardiac Failure

Interventions

Type	Name	Description
DEVICE	Cova Patch	CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours

Timeline

• Start date: 2020-02-19
• Primary completion: 2020-04-09
• Completion: 2020-04-09
• First posted: 2020-02-05
• Last updated: 2022-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study