Human factor engineering of point-of-care near infrared spectroscopy device for intracranial hemorrhage detection in Traumatic Brain Injury: A multi-center comparative study using a hybrid methodology.

OBJECTIVE: This study assessed machine learning powered Near-infrared spectroscopy based (mNIRS) device's usability and human factor ergonomics in four distinct healthcare provider groups. BACKGROUND: Traumatic Brain Injury (TBI) is a global concern with significant well-being implications. Timely intracranial hemorrhage (ICH) detection is crucial. mNIRS offers efficient non-invasive TBI screening. METHODS: Two device utilization stages involved operators (N = 21) and TBI-suspected subjects (n = 120). A hybrid approach used qualitative and quantitative methods, utilizing a 57-item survey and task completion time. RESULTS: All groups positively perceived user-interface, physical, cognitive, and organizational ergonomics. The device's ease of use, calibration, size, cognitive support, and integration gained appreciation. Training reduced task completion time from 16.5 to 13.2 s. CONCLUSION: mNIRS-based CEREBO® proves usable for TBI point-of-care assessment. Positive feedback from diverse healthcare groups validates design and cost-effectiveness alignment. A hybrid approach, training, and practice scans enhance usage and experience.

Evaluating CAPO®: A biocompatibility, transparency, and fitment assessment for use with CEREBO® in traumatic intracranial injury detection.

Healthcare-associated infections (HAIs) are a global concern affecting millions of patients, requiring robust infection prevention and control measures. In particular, patients with traumatic brain injury (TBI) are highly susceptible to nosocomial infections, emphasizing the importance of infection control. Non-invasive near infrared spectroscopy (NIRS) device, CEREBO® integrated with a disposable component CAPO® has emerged as a valuable tool for TBI patient triage and this study evaluated the safety and efficacy of this combination. Biocompatibility tests confirmed safety and transparency assessments demonstrated excellent light transmission. Clinical evaluation with 598 enrollments demonstrated high accuracy of CEREBO® in detecting traumatic intracranial hemorrhage. During these evaluations, the cap fitted well and moved smoothly with the probes demonstrating appropriate flexibility. These findings support the efficacy of the CAPO® and CEREBO® combination, potentially improving infection control and enhancing intracranial hemorrhage detection for TBI patient triage. Ultimately, this can lead to better healthcare outcomes and reduced global HAIs.