Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04008160 |
| Other study ID # |
2013-04 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
September 2021 |
| Source |
Swiss Paraplegic Centre Nottwil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Pressure injuries are a major problem in patients with no or limited mobility and sensation
such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation
and humidity may explain and help to detect pressure injury development earlier. Thus, these
parameters may be used for continuous monitoring of skin health. So far, there is no
measuring technology available which would allow to measure continuously and quantitatively
the physiological parameters, which are essential in the development of pressure injuries,
over a long period of time in the clinical setting.
The goal of this pilot study is to test whether this wearable technology can be used for
measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and
oxygenation can be measured safely and accurately.
10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements
with this newly developed device over the ischium for 30 minutes. The reproducibility of the
measurements will be investigated.
Description:
Background of the study:
Pressure injury is a major problem in patients with no or limited mobility and sensation such
as paraplegics. One of the main principles to prevent development of pressure injury is to
reduce the pressure over certain regions by changing the resting or lying position
periodically. Paraplegics who are suffering from loss of sensation in some parts of the body
are at high risk because of the missing internal trigger to change the position regularly.
Many studies have addressed the personal, social, medical and economic consequences of
pressure injuries. Some studies have investigated solutions aiming to reduce the probability
of pressure injury development, such as special mattresses or the frequency of moving the
patients from one side to the other etc. So far it has not yet been possible to
quantitatively and continuously measure the physiological skin parameters, which are
essential in the development of pressure injury, over a long period of time. Up to now,
long-term studies on paraplegics are limited because there are no suitable measurement
devices. Current measurement devices are hard and inflexible and increase the probability of
pressure ulcer development in paraplegics by applying external pressure on the tissue. In
this project, the applicability of wearable measuring systems, which do not apply external
pressure on the tissue, will be evaluated in paraplegics.
Aim of the study:
The goal of the study is to answer the following questions:
1. Is wearable technology usable for skin physiology measurements in paraplegics?
2. Are the measurements of skin temperature, pressure, humidity, perfusion, and oxygenation
reproducible in able bodied individuals?
3. Do changes in skin temperature, pressure, humidity, perfusion, and oxygenation differ
between paraplegics and healthy subjects?
Study design Two different measurement patches will be used. One patch consists of
temperature, pressure, humidity and perfusion sensors. The second patch consists of
near-infrared spectroscopy (NIRS) sensors (to measure oxygenation). This patch is designed
for non-invasive measurement of oxygenation parameters such as oxygen saturation, oxygen
consumption etc. The study is divided into two parts. The first part will be performed in 10
healthy subjects and 3 paraplegics. There will be two measurements in paraplegics and three
measurements in healthy subjects, each for 10 minutes. The second part which will be
conducted in 10-20 subjects (5-10 healthy and 5-10 paraplegics). The skin parameters will be
measured for an hour.
Part 1a healthy subjects:
The subject will acclimatize in the room where the experiment takes place for 15 minutes.
Then the patch will be placed over the ischium of the patient. Ischium will be localized
manually and the patch will be placed in the underwear of the participant. The subject will
be asked to sit for 10 minutes in a chair.
Part 1b paraplegics:
The subject will acclimatize in the room where the experiment takes place for 15 minutes.
Then the patch will be placed over the ischium of the patient. Ischium will be localized
manually and the patch will be placed in the underwear of the participant. The subject will
be asked to sit for 10 minutes in a in a standard wheelchair.
Part 2:
The same procedure will be carried out with the only difference that the measurements will
last 60 minutes.
Statistical Analyses:
Data will be analyzed descriptively. The reproducibility of the data will be analyzed using
intraclass correlation coefficients (ICC).
The differences between data from paraplegics and that of healthy subjects will be analyzed
using the Mann-Whitney-U-Test.
.
