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

ABSTRACT

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.