An Optical System for Measuring Blood Pressure

Correlation of Blood Pressure Measurements Using an Optical System for Measuring Blood Pressure

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.

Study Overview

• Status: Unknown
• Conditions: Blood Pressure Disorders
• Intervention / Treatment: Device: Blood pressure measurement; Device: Blood pressure measurement with the new device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Blood pressure measurement; Blood pressure measurement with a standard plethysmograph; Device: Blood pressure measurement with the new device; Blood pressure measurement with the optical sensor, Elfor -1 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure reading	Measurements will be performed with a standard plethysmograph and with a new sensor	three hours

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2017
• Primary Completion (Anticipated): February 15, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0265-16-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No