Limitations
There are several limitations to our study. First, we had greater data attrition than expected due to data loss from storage failure in the downloading of data from the CBPM system at the start of our study. This unanticipated data loss underscores the need for research teams to secure robust data back-up in future studies of this technology, especially when terabytes of data are being produced, as was the case in this study. As a result of this data loss, our study was underpowered (post hoc calculated power 52%), which might explain the non–statistically significant outcomes. We were also underpowered to detect new-onset PIs due to the relatively low incidence of PI at 72 hours. To address this challenge of statistical power to study hard clinical end points will probably require a multicenter study with a much larger sample size and longer follow-up. A second limitation is that improved nursing interventions at the bedside, such as avoidance of 90-degree lateral positioning, could have also contributed to more stable pressure profiles,Weighing against these limitations are some clear strengths. This was a substantial RCT assessing the efficacy of a CBPM system on interface pressures as a risk factor for PI development. We also used clinically relevant outcomes juxtaposed to the pressure sensels readings to add correlative measurements. The study was not funded by the device manufacturer, but rather through competitive peer-reviewed public sector funding. Furthermore, our research team had no affiliation with the CBPM system manufacturer.