MRT02: Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography

Sponsor

Afeka, The Tel-Aviv Academic College of Engineering (Other)

Overall Status

Completed

CT.gov ID

NCT03357523

Collaborator

Hebrew University of Jerusalem (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Microcirculation	Device: Omnilux new-U (Red LED) Device: Omnilux new-U (Near infrared LED) Device: RESPeRATE Device: Heating bag	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Red LED Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag	Device: Omnilux new-U (Red LED) 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 Device: RESPeRATE 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 Device: Heating bag Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
Active Comparator: Near Infrared LED Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag	Device: Omnilux new-U (Near infrared LED) 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 Device: RESPeRATE 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 Device: Heating bag Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds

Arm

Intervention/Treatment

Experimental: Red LED

Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag

Device: Omnilux new-U (Red LED)

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

Device: RESPeRATE

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

Device: Heating bag

Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds

Active Comparator: Near Infrared LED

Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag

Device: Omnilux new-U (Near infrared LED)

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

Device: RESPeRATE

Device: Heating bag

Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds

Outcome Measures

Primary Outcome Measures

Capillary blood flow [Up to 1 hour]
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.

Secondary Outcome Measures

Temperature distribution over hands measured by thermography [Up to 1 hour]
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.
Tissue oxygenation (tcPO2) [Up to 1 hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy males and females, between 23 and 45 years of age.
Willing to sign informed consent

Exclusion Criteria:

Currently smoking
Any abnormal skin condition in the area of light irradiation.
Pregnant having given birth less than 3 months ago, and/or breastfeeding.
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.
Having any illness that might affect the vasculature, such as diabetes (type I or II)
Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Afeka, Tel-Aviv Academic College of Engineering	Tel Aviv		Israel

Sponsors and Collaborators

Afeka, The Tel-Aviv Academic College of Engineering
Hebrew University of Jerusalem

Investigators

Principal Investigator: Zehava Blechman, PhD, Afeka Tel Aviv Academic College of Engineering

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Afeka, The Tel-Aviv Academic College of Engineering

ClinicalTrials.gov Identifier:

NCT03357523

Other Study ID Numbers:

05.04.2017-1-AFK

First Posted:

Nov 30, 2017

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 10, 2021