JMIR Publications

ABSTRACT

Background:

Pressure injuries are driven by interacting mechanical, perfusion, and microclimate factors. Sensor-enabled support surfaces can characterize interface conditions, whereas oxygen-based approaches have been studied mainly in wound-healing contexts. Evidence for combining these functions in a support surface for primary pressure-injury prevention remains preliminary.

Objective:

To develop and bench-characterize an integrated support-surface prototype that combines pressure, temperature, and relative-humidity sensing with preset low-flow oxygen delivery, and to define the technical evidence that can be supported before clinical testing.

Methods:

Pressure measurements were compared with reference loads of 40, 80, and 120 mmHg. Microclimate sensing was assessed across reference ranges of 32-36 °C and 40%-75% relative humidity. The oxygen-delivery subsystem was operated at a preset 1.0 L/min for 6, 12, and 24 hours. The retained study record contained summary-level bench data; independent-run counts, observation counts, and sampling frequencies were not recoverable. Outcomes were descriptive: measured mean, SD, coefficient of variation (CV), absolute bias of the reported pressure mean, oxygen-flow deviation from preset, surface temperature and relative-humidity change, and 24-hour relative sensor change. No post hoc pass/fail threshold or inferential clinical test was applied.

Results:

At 40, 80, and 120 mmHg references, measured pressure means were 41.2 (SD 1.5), 78.9 (SD 2.1), and 118.4 (SD 2.8) mmHg. Absolute bias of the reported mean was 1.2, 1.1, and 1.6 mmHg (1.3%-3.0% of the respective references), while CV decreased from 3.6% to 2.4%. Reported mean microclimate errors were 0.3 °C for temperature and 2.1 percentage points for relative humidity. Mean oxygen flow was 0.99 (SD 0.04), 1.01 (SD 0.05), and 0.98 (SD 0.05) L/min at 6, 12, and 24 hours, corresponding to mean deviations of -1%, +1%, and -2% from the preset. Surface temperature changed by +0.3 to +0.5 °C and relative humidity by +1.8 to +2.4 percentage points. Reported 24-hour relative changes were +1.9%, +0.6%, and +2.3% for pressure, temperature, and humidity channels, respectively.

Conclusions:

The prototype demonstrated concurrent short-term operation of multimodal sensing and preset low-flow oxygen delivery under the tested bench conditions. The present evidence supports an integrated engineering proof of concept, not therapeutic efficacy. Interface oxygen concentration, spatial oxygen distribution under body load, pressure redistribution, dynamic sensor performance, induced-fault response, independent multi-prototype reproducibility, and clinical outcomes require prospective validation.