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Completed

NCT Number: NCT03357523

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

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

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Key information

Conditions

Age range

23 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Resperate

Device

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

Device

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

Primary outcomes

  1. Capillary blood flow

    Time frame: 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 outcomes

  1. Temperature distribution over hands measured by thermography

    Time frame: 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.

  2. Tissue oxygenation (tcPO2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Afeka, The Tel-Aviv Academic College of Engineering

Other

Collaborators

  • Hebrew University of Jerusalem

Registry information

Official study title

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

Acronym: MRT02

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 30, 2017
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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