Afdrukken in de huid, huidtemperatuur en comfort van twee nekkragen

Background

Trauma patients who are immobilized with a cervical collar for preventive reasons, are at risk for developing collar related pressure ulcers (CRPU). There is a possibility that the Philadelphia cervical collar (C- collar) is a more favourable alternative for preventive immobilization using the Stifneck C-collar in trauma patients. However, the influence of risk factors for CRPU in the latest versions of these C-collars remains unclear due to lack of recent studies. Besides the patients’ condition, produced pressure, fit of the medical device and increased skin temperature seem relevant risk factors. It is possible that comfort and indentation marks (IM) are a sign of the exerted pressure and fit of the C-collar.



Aims

Primary Objective is to evaluate the effect of the Stifneck and Philadelphia cervical collar on incidence and severity of IM in immobilized healthy volunteers. Secondary Objectives are to evaluate the effect of the Stifneck and Philadelphia cervical collar on skin temperature and experienced comfort in immobilized healthy volunteers.



Design

Single-blinded randomized controlled trial.



Population

Healthy human volunteers from eighteen till 65 years old.



Intervention

One group receives the Stifneck C-collar and the other group receives the Philadelphia C- collar. Both groups are immobilized for 20 minutes in the C-collar.



Main study parameters

The main study parameter is the incidence of IM at the end of the immobilization time divided in no, mild or severe IM. In addition, skin temperature is measured by an infrared thermometer and experienced comfort is assessed by a five-point Likert scale.



Analysis

Difference between groups for the main parameter is tested by a Chi-square test. Secondary parameters are tested on differences by unpaired sample T-test and Chi-square test.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness

Participants have one site visit of about 30 minutes. There are no risks while participating in the study.

There is a possibility that the Philadelphia neck collar gives better results than the stifneck collar on the proposed outcomes.

T0: before immobilization in the cervical collar

T1: after 20 minutes of immobilization in the cervical collar

1. Laerdal Stifneck cervical collar

2. Philadelphia Tracheatomy cervical collar