'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals

• Conditions: Blood Pressure

• Registration Number: NCT03409861
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

Detailed Description

The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.

The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.

The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-24
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Signed written Institution approved Informed Consent Form (ICF)
2. Male and Females over the age of 18 years
3. Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
4. Only subjects who are fitted with an invasive Arterial Line (A LINE)
5. To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.

Exclusion Criteria

1. Subject who are unable to provide consent
2. Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
3. Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Pressure Monitoring	30-60 seconds of a clean signal from the A-line monitor	Wearing of a non invasive wristband to measure Blood Pressure