An Optical System for Measuring Blood Pressure

NCT ID: NCT03042949

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2018-04-01

Brief Summary

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An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device. The system is based on a small optical sensor that emits coherent light into the skin and collects the reflected light from the red blood cells in the blood vessels in the skin under the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.

The investigators plan to measure blood pressure with the new sensor in patients who are attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate the sensor.

Detailed Description

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If the blood flow is temporarily interrupted by inflating a small pneumatic cuff at the root of the finger, blood flow is occluded and the pulse wave disappears. As the pressure in the cuff is released, blood flow returns, the pulse wave is again detected and blood pressure can be measured. This apparatus is easy to use and will allow simplified monitoring of blood pressure contains the laser source and optical sensors that measure the reflected light.

The investigators proposed to validate the sensor by measuring the blood pressure in patients with this optical sensor and also by standard plethysmography. The investigators plan to measure participants with low, normal and high blood pressure in order to assess the accuracy and reliability of the new device.

Conditions

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Blood Pressure Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will have their blood pressure measured by standard plethysmography and with a new optical device
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Blood pressure measurement

Patients requiring blood pressure measurement will have their blood pressure measured in the standard manner by plethysmography, and then with the Elfor -1 device , the new optical sensor, in order to determine the performance of the new sensor.

Group Type EXPERIMENTAL

Blood pressure measurement

Intervention Type DEVICE

Blood pressure measurement with a standard plethysmograph

Blood pressure measurement with the new device

Intervention Type DEVICE

Blood pressure measurement with the optical sensor, Elfor -1 device.

Interventions

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Blood pressure measurement

Blood pressure measurement with a standard plethysmograph

Intervention Type DEVICE

Blood pressure measurement with the new device

Blood pressure measurement with the optical sensor, Elfor -1 device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients on hemodialysis or visiting the hypertension outpatient clinic at Meir Medical Hospital.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Naomi Nacasch

Principle Invastigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0265-16-MMC

Identifier Type: -

Identifier Source: org_study_id

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