We want to study whether there is a difference with respect to the pressure exerted onto the body when using a normal spineboard and a newly developed spineboard, related to the level of consciousness of the volunteer. Also the experienced comfort…
ID
Source
Brief title
Condition
- Injuries NEC
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pressure on the body such as measured with a pressure measuring device.
Secondary outcome
Redness of the skin, experienced comfort of the material the patient had been
lying on.
Background summary
Transportation of trauma patients on a spineboard is associated with certain
risks: because of the hard surface of the currently used spineboard patients
are at risk for developing pressure ulcers, especially when they lie on the
surface for prolonged periods of time. Furthermore, the discomfort of lying on
a hard surface may cause the patient trying to move around in order to find a
more comfortable position. If the patient has an unstable vertebral fracture,
this may result in the unfavourable situation where the injury becomes more
serious due to movements of the patient. The worst case scenario would be that
movement of the unstable fracture causes damage to the spinal cord, thereby
leaving the patient paralysed. It is therefore of the utmost importance that
research is done to find alternatives for this spineboard. This study is aimed
at evaluating such an alternative.
Study objective
We want to study whether there is a difference with respect to the pressure
exerted onto the body when using a normal spineboard and a newly developed
spineboard, related to the level of consciousness of the volunteer. Also the
experienced comfort for lying on the normal spineboard and lying on the newly
developed spineboard will be evaluated.
Study design
Prospective randomised multicenter intervention study.
Intervention
Patients are randomly assigned to one of the two study groups. Participating
patients are lifted onto one of the two spineboard after they have received
their anaesthetics.
Study burden and risks
The burden of this study comprises a time investment of 15 minutes used for
explaining the nature of the study and the answering of a limited number of
questions after the surgery.
The volunteers are at limited risk of developing non-blanchable redness of the
skin (decubitus 1st grade). This risk is very small since the time spent on the
spineboard will be limited.
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
surgery under general anaesthetics
Exclusion criteria
decubitus in medical history
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 | NL18313.068.07 |