Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Capillary blood flow
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 23 Years to 45 Years (Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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
- Temperature distribution over hands measured by thermography(Up to 1 hour)
- Tissue oxygenation (tcPO2)(Up to 1 hour)