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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03357523
Acronym
MRT02
Enrollment
20
Registered
2017-11-30
Start date
2017-11-01
Completion date
2019-12-31
Last updated
2021-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculation

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.

Interventions

DEVICEOmnilux 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

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

DEVICERESPeRATE

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

DEVICEHeating bag

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
23 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Capillary blood flowUp to 1 hourCapillary 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

MeasureTime frameDescription
Temperature distribution over hands measured by thermographyUp to 1 hourThermographic 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 hourTissue 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026