Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Details

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.

Keywords

Cardiac Failure Heart Failure Cova Patch Men/Women who meet the inclusion/exclusion criteria

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • Cardiac ICU
    Los Angeles California 90095 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
toSense, Inc.
ID
NCT04255108
Study Type
Observational
Last Updated