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

Microcirculation Clinical Trial

— MRT02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357523
• Other study ID #: 05.04.2017-1-AFK
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2021
• Source: Afeka, The Tel-Aviv Academic College of Engineering
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microcirculation

Intervention

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

Locations

Country	Name	City	State
Israel	Afeka, Tel-Aviv Academic College of Engineering	Tel Aviv

Sponsors (2)

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

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 hour
Secondary	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.	Up to 1 hour
Secondary	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.	Up to 1 hour