An Optical System for Measuring Blood Pressure

Blood Pressure Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03042949
• Other study ID #: 0265-16-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: February 8, 2017
• Start date: February 15, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: February 2017
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Blood Pressure Disorders

Intervention

Device:
• Blood pressure measurement
Blood pressure measurement with a standard plethysmograph
• Blood pressure measurement with the new device
Blood pressure measurement with the optical sensor, Elfor -1 device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure reading	Measurements will be performed with a standard plethysmograph and with a new sensor	three hours