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

Cardiac Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure

• NCT number: NCT04255108
• Study type: Observational
• Source: Baxter Healthcare Corporation
• Status: Completed
• Start date: February 19, 2020
• Completion date: April 9, 2020