SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation

The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain. Procedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen. SED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression). In this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced. The study complies with MDR 2017/745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB/2026/0307). Expected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.

Inclusion Criteria: * Age ≥18 years * ASA physical status I-III * Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure * Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system * Administration of sedative and analgesic drugs via a peripheral venous line * Ability to understand the study information and provide written informed consent Exclusion Criteria: * Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders). * Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response * ASA physical status IV, V or VI * Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring * Requirement for central venous access for drug administration * Sedation performed outside the endoscopy unit (e.g., intensive care, emergency department) * Inability to understand study information, provide consent or cooperate with clinical assessments due to language barrier or cognitive impairment