tissue oxygenation, tissue perfusion
Conditions
Interventions
hyperspectral images will be made after induction of occlusion, local vasoconstriction and vasodilation of the forearm of the volunteers.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history. - Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg. - Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: - History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. - Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg. - Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the sponsor. - Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. - Smokers as defined by any of the following criteria: o Reported smoking of cigarettes within 12 months prior to screening; occasionally a cigarette is allowed, but not within 24 hours of the measurements. - Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). - Unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility, applicability, and reproducibility of a novel hyperspectral camera system in perfusion and oxygenation detection in healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hyperspectral measures of: 1. basal blood flow / oximetry 2. blood flow /oximetry upon occlusion-reperfusion brachial artery 3. Blood flow / oximetry after applying capsaicin-based cream 4. Blood flow/ oximetry after applying brimonidine | — |
Contacts
Public ContactSven Mieog
leiden university medical center
Outcome results
None listed