Development of a Method for Continuous Absolute Non-inflating Measurement of Blood Pressure Using CardiacSense1BP

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    CardiacSense Ltd.
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Updated on 19 February 2024
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Summary

The primary objective of this research is to collect data for development of an algorithm for continuous, non-inflating measurement of absolute, long term Blood Pressure, using CardiacSense1BP device and to evaluate the safety of the CardiacSense1BP.

Description

The study will take place in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) units, on non-anaesthetized subjects with an arterial line inserted into the radial artery. Continuous recording will be performed in parallel using invasive arterial line recording and CardiacSenseBP1 non-invasive recording. The ECG data recorded in the ICU will also be obtained. .

Up to 80 subjects will be included in the study.

The subject will possibly be connected to the CardiacSense1BP device a few times to check repeatability. The first measurement will be of up to 24h. Subsequent measurements will be of up to 5h. Data analysis will be performed offline.

Data is collected for CardiacSense1BP device algorithm development.

Details
Condition Blood Pressure, Blood pressure
Age 18years - 100years
Treatment CardiacSense1BP
Clinical Study IdentifierNCT04215185
SponsorCardiacSense Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age of eighteen (18) year and above
Ability and willingness to sign an informed consent form
Monitored by radial arterial line

Exclusion Criteria

Subjects with hemodynamic support
Subjects receiving more than 2-3 l of fluid per 24h
Subjects with septic shock
Subjects with distal edema
Subjects with arms trauma, where the watch is not wearable
Subjects where the radial artery could not be palpate
Subjects with life expectancy of less than 24h
Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)
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