Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography

Afeka, The Tel-Aviv Academic College of Engineering20 enrolled

Overview

The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler

This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Microcirculation

Interventions

Omnilux new-U (Red LED)DEVICE

The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated

Omnilux new-U (Near infrared LED)DEVICE

The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated

RESPeRATEDEVICE

The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm

Eligibility

Sex: ALLMin age: 23 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy males and females, between 23 and 45 years of age. 2. Willing to sign informed consent Exclusion Criteria: 1. Currently smoking 2. Any abnormal skin condition in the area of light irradiation. 3. Pregnant having given birth less than 3 months ago, and/or breastfeeding. 4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen. 5. Having any illness that might affect the vasculature, such as diabetes (type I or II) 6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders. 7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Locations (1)

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Israel

Outcomes

Primary Outcomes

Capillary blood flow

Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler (Biopac™ System, Inc, USA). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.

Time frame: Up to 1 hour

Secondary Outcomes

Temperature distribution over hands measured by thermography

Thermographic images will be photographed with a FLIR camera and temperature distribution will be analysed. Photos will be taken every minute from baseline to end of experiment.

Time frame: Up to 1 hour

Tissue oxygenation (tcPO2)

Tissue oxygenation (tcPO2) measured by electrodes mounted on both hands (Perimed™ system, Sweden). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.

Time frame: Up to 1 hour

Data from ClinicalTrials.gov

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