Health Adult Subjects, Pressure Injury Prevention
Conditions
Keywords
caylis, Arjo
Brief summary
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
Detailed description
This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market (Caylis Pro® LAL System). A secondary aim is to compare the frequency and amplitude of different pulsation modes with respect to the biomechanical and physiological responses at the participant-support surface interface.
Interventions
DEVICECLP and pulsation
As an alternative to manual repositioning, advanced air mattress systems have been introduced to periodically relieve support pressures. A number of measurements have been used to examine the performance of support surfaces. As an example, interface pressure measurements between the individual and the support surface have been extensively used in both lab-based and clinical studies . We are now investigation the functions to reduce pressure in our new Caylis mattress
Sponsors
Arjo AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
During the test each volunteer will adopt three distinct postures namely supine, lateral lying (pelvis titled to 30°) and cardiac high sitting (head of bed at 45°), while a series of measurements will be performed at the individual-support surface interface.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-85 * Healthy male or female
Exclusion criteria
* Systemic skin disease * History of pressure ulcers in the sacrum or heels * Diabetes * Long term steroid use * Inability to maintain lying posture for prolonged periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market. | Day 1 and 2 | * Comfort, support and firmness scores (using a 7 point verbal rating scale ) * Interface pressure distribution (ForeSitePT, XSensor) * Transcutaneous gas levels * Microclimate measures between the participant and the support surface using temperature and humidity sensors (Sensiron SH75). * Internal Mattress air pressures |
Contacts
Primary ContactPete Worsley, Prof, Dr, PhD
Backup ContactKarin M Hannander, RN, Dir
Outcome results
None listed