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

Not Applicable

Completed

• Conditions: Microcirculation
• Interventions: Device: Omnilux new-U (Red LED); Device: Omnilux new-U (Near infrared LED); Device: RESPeRATE; Device: Heating bag

• Registration Number: NCT03357523
• Lead Sponsor: Afeka, The Tel-Aviv Academic College of Engineering

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

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-30
• Primary Completion: 2018-06-01
• Study Completion: 2019-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red LED	Omnilux new-U (Red LED)	Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
Red LED	Heating bag	Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
Red LED	RESPeRATE	Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
Near Infrared LED	Heating bag	Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
Near Infrared LED	Omnilux new-U (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
Near Infrared LED	RESPeRATE	Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Afeka, Tel-Aviv Academic College of Engineering; 🇮🇱 Tel Aviv, Israel