The aim of the study is to investigate whether hyperspectral imaging can be used as a noninvasive method for the assessment of changes in StO2 in the forearm of human volunteers during a vascular occlusion test.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the level of agreement between the StO2 measured by hyperspectral
imaging and the StO2 measured by near infrared spectroscopy as gold standard
for microcirculatory measurements during a vascular occlusion test?
Secondary outcome
What are the patterns in SpO2 as measured by pulse oximetry during a vascular
occlusion test?
What are the changes in skin temperature as measured by a thermographic camera
during a vascular occlusion test?
Background summary
The microcirculation plays a crucial role in the process of tissue oxygenation,
perfusion and nutritional exchange. At a microcirculation level, oxygen and
carbon dioxide are exchanged, and tissue waste products eliminated. Anesthesia
and surgery have a large impact on system hemodynamics, and this is
subsequently associated with a wide range of changes in microcirculatory
perfusion and oxygenation. Despite normalization of macrohemodynamic
parameters, we previously showed that significant dysfunction of
microcirculatory perfusion may persist, e.g. during cardiac surgery, even
throughout the postoperative period. Moreover, our group showed that
macrohemodynamic changes are not representative for microcirculatory function.
Measurements of microcirculatory behavior in the clinical setting present a
particular challenge, because vessel structure is inhomogeneous and perfusion
is highly variable during surgery. Unfortunately, most available tools, such as
Sidestream Darkfield Imaging or contrast-enhanced ultrasound may never leave
the experimental setting in the context of perioperative care. The ideal tool
for measuring the microcirculation would be an easy to use, non-invasive,
non-contact device that provides real-time information about regional tissue
oxygenation and perfusion of different organs. One emerging imaging technique
may be useful in microcirculatory imaging: hyperspectral imaging (HSI). This
type of imaging is based on a non-contact visualization of alterations in the
tissue wavelength profile.
Study objective
The aim of the study is to investigate whether hyperspectral imaging can be
used as a noninvasive method for the assessment of changes in StO2 in the
forearm of human volunteers during a vascular occlusion test.
Study design
Open label, non-randomized, observational study
Intervention
Vascular occlusion test
Study burden and risks
There are no risks associated with this study. The camera's used for this study
use mostly near infrared light to measure the different light spectra of
oxyhemoglobin an deoxyhemoglobin. There is minimal extra burden for the
volunteer consists of a forearm occlusion and a possible pain sensation. This
pain sensation almost directly disappears after deflation of the blood pressure
cuff.
De Boelelaan 1117 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a volunteer must meet all of the following criteria:
* Age: 18 - 65 years old
* Male and female from all ethnicities
* Informed consent
Exclusion criteria
A potential participant in this study who meets any of the following criteria
will be excluded from participation in this study:
* Renaud*s disease
* Peripheral vascular dysfunction
* Infectious diseases.
* Burns of the skin of the arms
* Diabetes Mellitus type I or II
* Volunteers with a left-right difference in systolic blood pressure >10mmHg at the wrists
Design
Recruitment
Medical products/devices used
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 | NL56684.029.16 |