Aim: The aim of this study was to analyse the change in peripheral oxygenation
and microvascular flow in tissues subjected to different pressure regimes in healthy
subjects and in hospitalized patients.
Background: The presence of pressure ulcers in hospitalized patients is a common
complication that has a negative impact on health and often prolongs hospital stay
and increases healthcare costs.
Design: Experimental non-controlled, non-randomized study in two phases: pre-clinical
and clinical.
Methods: The pre-clinical phase will be conducted in healthy volunteers and the clinical
phase, in patients at risk of impaired skin integrity. Vascular flow, tissue oxygenation
and local temperature in areas at risk of pressure ulcers will be evaluated by
Doppler laser in subjects lying on a capacitive surface to measure pressure at 10,249
points. Different levels of pressure will be generated by changes in body position and
changes in tissue perfusion and oxygenation will be monitored for up to 4 hours, to
determine the implications for repositioning interventions in patients at risk. This
study was funded in July 2015. The protocol is registered in ClinicalTrials.
gov (NCT02736838).
Discussion: Pressure ulcer is a significant and complex health problem in long-term
bedridden patients and there is currently no effective treatment or efficient prevention
method. The information provided by our study will provide an accurate assessment
of different thresholds for the onset of damage to the skin, associated with
different body positions and pressure levels.
Trial Registration: The protocol is registered in ClinicalTrials.gov (NCT02736838).
