Primary Objective: To investigate the feasibility, applicability, and reproducibility of a novel hyperspectral camera system in perfusion and oxygenation detection in healthy volunteers.Secondary Objectives: - To explore the effect of occlusion-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Perfusie gerelateerde stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Feasibility and applicability is achieved as the researchers were able to
produce hyperspectral images, which were available to analysis without too much
noise caused by an unstandardized measurements.
2) Reproducibility is measured by repeating the measurements on two different
days in the same study population. Therefore, the following parameters will be
evaluated by LSCI:
- Basal blood flow
- Blood blow upon occlusion-reperfusion brachial artery
- Blood flow after applying capsaicin-based cream and brimonidine
Secondary outcome
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
The endpoint of the study is if a selection of spectral bands, specific for
tissue perfusion and oxygenation, which will be selected after data processing
of above mentioned measurements, could be achieved.
Background summary
Feasibility and reproducibility of a hyperspectral camera system in human skin
perfusion and oxygenation detection will be evaluated, resulting in selection
of spectral bands, which could be used in clinical practice.
Study objective
Primary Objective:
To investigate the feasibility, applicability, and reproducibility of a novel
hyperspectral camera system in perfusion and oxygenation detection in healthy
volunteers.
Secondary Objectives:
- To explore the effect of occlusion-reperfusion of the brachial artery on
cutaneous blood flow as assessed by a hyperspectral camera system.
- To explore the effect of applying topical vasoconstrictors / vasodilators on
the cutaneous blood flow as assessed by a hyperspectral camera system.
- Selection of relevant spectral bands for oxygenation and perfusion detection.
Study design
Open observational multicenter study.
Intervention
To induce local vasoconstriction and vasodilatation, brimonidine cream and
capsaicin cream will be applied on the forearm of the volunteers.
Study burden and risks
This study is a non-therapeutic trial, which evaluates the feasibility of the
hyperspectral camera system in evaluation of the tissue perfusion and
oxygenation in different circumstances. The main aim of this study is to select
relevant spectral bands for oxygenation and perfusion detection, which can be
used for further camera development and consequently in clinical practice.
There is no benefit for the recruited healthy human volunteers upon
participation to this study. However, the expected risks are minimal. The
hyperspectral imaging system uses halogen light, which is also widely used as a
commercial light source. The risk of drug side effects will be minimized by
accurate selection of volunteers. Moreover, the experiments will take place in
a controlled hospital setting.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
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: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).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL63242.058.17 |