Limitations
DECAY
The study was designed as an initial investigation into the benefits of a new silicone‐based patient‐side adhesive for pulse oximetry sensors. Gentleness of the adhesive was assessed on an elderly population with the intent to target fragile skin. However, no screening was performed on subjects to characterize fragile skin, and no age restrictions were used for the reapplication study. Further, pediatric patients were not included in the study population. The protein assay results for the silicone‐based adhesive were at the detection limit. Hence, the expected amount of protein removed by the silicone‐based adhesive would be lower than what was measured.The 180° peel test was used to assess reapplication. This testing assumes that stiffness is the same throughout the device backing. Although the stiffness between the optical and tail regions did differ, as seen in the bimodal peel profile, the adhesive coverage was uniform across the respective devices. Further, the decay curves for the tail and optical regions demonstrated the same dynamics.The sensor dwell time during the gentleness study was 4 h, timing that may be seen in the clinical setting. However, due to the time restraints of completing 18 reapplication trials, the dwell time of the sensors during this testing was only a few minutes. Clear differences between the two sensors were seen at six reapplications, demonstrating the superiority of the OxySoftN to MaxN in terms of reapplications.