o To test the linearity of the LSCI device (Perimed AB, Järfälla, Sweden) and LDI device (Moor Instruments, Devon, UK) in a wide range of blood flux valueso To compare arbitrary units of two different kinds of laser-based devices and to create a…
ID
Source
Brief title
Acronym:LACOM Study= LAser COMpare study
Condition
- Other condition
- Skin vascular abnormalities
Synonym
Health condition
microcirculation and tissue perfusion
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Standard operating procedure for measurement of cutaneous microcirculatory
perfusion: mean blood flux values [LSCI (Perimed AB, Järfälla, Sweden) & LDI
(Devon, UK)]
The study process in one volunteer will be ended once the iontophoresis and
stepwise occlusion completed.
Secondary outcome
na
Background summary
The microcirculation plays a fundamental role in the human body and it has been
shown as an essential determinant in many clinical scenarios such as shock
states, chronic and cardiac diseases. Microcirculation can be assessed directly
using laser-based techniques and intravital microscopes. When combined with
provocation tests, microvascular monitorization can be used to assess
microvascular function.
Laser-based techniques are consist of two different methods named laser doppler
imaging (LDI), laser speckle contrast imaging (LSCI). LSCI is a technique based
on speckle contrast analysis that provides an index of blood flux. No need for
skin contact, continuous and real-time assessment of the microcirculation led
the LSCI to be broadly used in clinical practice.
LDI is also a non-invasive diagnostic method used to measure blood flux of
tissue. The technique is based on measuring the doppler shift induced by moving
red blood cells to the illuminating coherent light. Iontophoresis is one of the
most commonly used provocation test to study the endothelium in terms of
endothelium-dependent and endothelium-independent vasodilation. Simultaneously
with LDI and LSCI are used to follow and assess the skin blood flux during
iontophoresis. Therefore, it provides a state to make a comparison between two
different laser-based techniques in terms of flux characteristics.
The accurate assessment of burn depth is a critical step in the management of
the burn-injured patient. Currently, LDI is the most widely used noninvasive
measurement tool for the assessment of burn wounds and the only technique that
has been approved by the U.S. Food and Drug Administration. However, LDI device
is rather costly, cumbersome and has a poor spatial resolution. LSCI measures
perfusion in a similar way, but it provides high quality images with a much
higher spatial resolution. In addition, LSCI is much quicker, maneuverable and
able to assess more larger skin areas. In order to use LSCI technique in
clinical practice of burn-injured patients, as a first step, linearity of LDI
and LSCI should be shown. In this study we aimed to compare LSCI and LDI with
iontophoresis and stepwise occlusion technique. So, we will be able to test the
linearity of devices over a large range of blood flux values.
Study objective
o To test the linearity of the LSCI device (Perimed AB, Järfälla, Sweden) and
LDI device (Moor Instruments, Devon, UK) in a wide range of blood flux values
o To compare arbitrary units of two different kinds of laser-based devices and
to create a common and universal unit
o To create a color code, comparing LDI and LSCI
Study design
Single-center, prospective, observational and non-interventional study in the
Maastad Hospital, Rotterdam, The Netherlands
Study burden and risks
Microcirculation assessment is a non-invasive procedure, and there are no risks
associated with LSCI and LDI devices. Additional blood tests are not required.
The risks can be considered negligible, and the burden can be considered
minimal. Major side-effects are rare with using iontophoresis. However, minor
reactions such as itching, erythema and general irritation of the iontophoresis
skin surface are common during procedure. Discoloration of the skin may occur.
s Gravendijkswal 230
Rotterdam 3000 CA
NL
s Gravendijkswal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Healthy human volunteers older than 18 years who conform to following criteria:
* Should not have any disease at the time of procedure (including flu)
* Should not have any chronic disease
* Should not be under any medication
* Should not be smoker or ex-smoker
* Should not drink coffee or eat the meal in two hours before the procedure
* Should not have an allergy to sodium-nitroprusside
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;* The volunteer who does not meet any of the criteria above
* <18 years old
* Pregnant
* Refusal to participate in the study or demand to end study for any reason
* Hypersensitivity/allergy to sodium nitroprusside
* Broken or damaged skin surfaces
* Electrically-sensitive implanted devices such as cardiac pacemakers
* Maastad Ziekenhuis employees or collegues
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL65747.101.18 |