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

Official title

Prospective Observational Clinical Investigation to Evaluate the Clinical Performance and Safety of a Medical Device Software (SED Pack) During Standard Procedural Sedation

Overview

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.

Detailed description

Investigational device: SED Pack is a Medical Device Software (MDSW) that continuously processes physiological monitoring data and drug-infusion parameters to generate four real-time predictive indices (scale 0-100, updated once per second): pSED (probability of sedation depth from light sedation to general anesthesia), pNOC (probability of motor response to mild noxious stimuli), pHYPO (probability of clinically relevant arterial hypotension), and pDEP (probability of clinically relevant respiratory depression). The software incorporates a predefined individualization step that adjusts patient-specific parameters within a fixed model structure based on observed physiological signals. This process is deterministic and does not involve adaptive learning, model retraining, or self-modification. The algorithmic structure, logic, and parameters are fully locked throughout the investigation.

Study design: Prospective, observational, single-arm, single-center clinical investigation conducted under Article 62 of Regulation (EU) 2017/745 at Hospital Clínic de Barcelona, Spain. The investigation is non-interventional: no additional procedures beyond standard clinical care are introduced. The SED Pack software is installed on a dedicated PC connected via wired, unidirectional, read-only serial interfaces to standard clinical monitoring systems; the PC is not connected to any wireless or hospital network during the investigation. The software operates in fully blinded mode throughout: its predictions are not visible to the attending anesthesiologist, endoscopist, nursing staff, or investigators performing clinical reference assessments, and there is no break-glass mechanism for real-time visualization. All clinical decisions rely exclusively on standard-of-care CE-marked monitoring systems.

Patient enrollment: Participants are recruited among adult patients scheduled for elective gastrointestinal endoscopic procedures requiring procedural sedation at Hospital Clínic de Barcelona. Potentially eligible patients are identified during routine pre-procedural evaluation, provided with a patient information sheet and an informed consent form, and enrolled only after written informed consent is obtained. Participation is entirely voluntary and refusal or withdrawal does not affect standard medical care. Because the investigation does not deviate from routine clinical practice and introduces no additional procedures or risks, no study-specific patient training is required.

Performance evaluation and statistical analysis: The primary objective is to evaluate the predictive performance of the four SED Pack indices (pSED, pNOC, pHYPO, and pDEP) against predefined clinical and physiological reference standards, using the concordance statistic (c-index) for pSED, pHYPO, and pDEP, and the AUC-ROC for pNOC, complemented by sensitivity and specificity analyses at predefined operational thresholds. Secondary objectives include evaluation of predictive performance at short-term prediction horizons (+5 and +10 minutes), threshold-based AUC-ROC analyses against predefined binary clinical thresholds, and exploratory subgroup analyses by ASA physical status, age group, and sex. One pre-planned interim analysis will be conducted after enrollment of approximately 50% of the target sample for data quality assessment purposes only.

The anticipated outcome of this investigation is the confirmation that the SED Pack predictive indices achieve clinically acceptable discrimination performance against predefined reference standards, supporting the clinical performance claims of this investigational software. Ultimately, SED Pack has the potential to transform the monitoring paradigm during procedural sedation by enabling clinicians to anticipate adverse events before they occur, improving patient safety and supporting more individualized drug management.

Primary outcome measures

• Discrimination Performance of pSED (Sedation Prediction Index) [Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)]
• Discrimination Performance of pNOC (Nociceptive Response Prediction Index) [Time frame: From the onset of procedural sedation to its completion, assessed at each endoscope insertion or manipulation event (estimated duration: 20 to 60 minutes per participant)]
• Discrimination Performance of pHYPO (Hypotension Prediction Index) [Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)]
• Discrimination Performance of pDEP (Respiratory Depression Prediction Index) [Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)]

Secondary outcome measures (3)

• Short-term Predictive Performance of pSED, pNOC, pHYPO, and pDEP at +5-Minute and +10-Minute Prediction Horizons [Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)]
• Threshold-based Discrimination Performance of pSED, pHYPO, and pDEP Against Predefined Binary Clinical Thresholds [Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)]
• Exploratory Subgroup Analyses of Predictive Performance by ASA Physical Status, Age Group, and Sex [Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Hospital Clínic de Barcelona — Barcelona

Identifiers

NCT: NCT07749781 · SED-PACK-1608-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗