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

Completed

Conditions studied: Cardiac Failure

In brief

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.

Key facts

Study ID

NCT04255108

Run by

Baxter Healthcare Corporation

People needed

50

Starts

2020-02-19

Expected to finish

2020-04-09

Last updated by the study team

2022-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Cardiac ICU — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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