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

Non-invasive, Non-Oscillometric Blood Pressure Band

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03409861

Enrollment

Registered

2018-01-24

Start date

2018-01-31

Completion date

2018-01-31

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactMichal Binebaum

michal.binenbaum@guardlyff.com972(0)547299564

Outcome results