Peripheral perfusion and oxygenation in areas of risk of skin integrity impairment exposed to pressure patterns. A phase I trial (POTER Study)

Abstract

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).