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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255108
• Other study ID #: TS-IRB-0003.1
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: April 9, 2020

Study information

• Verified date: January 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female = 18 years of age at Visit X.
• Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• Subject is not pregnant at the time of consent

Exclusion Criteria:

• Pregnant in the study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure

Intervention

Device:
• Cova Patch
CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours

Locations

Country	Name	City	State
United States	Cardiac ICU	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Stroke Volume	The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method.; Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.	4 Months
Primary	Accuracy of Cardiac Output	The secondary objective of this study is to validate cardiac output (the amount of blood the heart pumps per minute) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method.; Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery catheter.	4 Months