SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPredictheon Medical, S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients scheduled for elective, non-emergent gastrointestinal endoscopic procedures requiring standard procedural sedation with propofol and remifentanil via TCI at the Endoscopy Unit of Hospital Clínic de Barcelona, Spain. Patients are identified during routine pre-procedural evaluation and enrolled consecutively after provision of written informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Discrimination Performance of pSED (Sedation Prediction Index)
Concordance statistic (c-index) comparing continuous pSED predictions against an ordinal clinical sedation scale (OAA/S- and Ramsay-derived; Level 1: light/no sedation; Level 2: moderate sedation; Level 3: deep sedation; Level 4: general anesthesia) assessed every 5 minutes by the investigator.
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)2
Discrimination Performance of pNOC (Nociceptive Response Prediction Index)
AUC-ROC comparing continuous pNOC predictions against a binary reference standard: presence or absence of motor response (gag reflex or involuntary limb movement) during endoscope insertion or manipulation.
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)3
Discrimination Performance of pHYPO (Hypotension Prediction Index)
Concordance statistic (c-index) comparing continuous pHYPO predictions against non-invasive mean arterial pressure (MAP) measurements obtained at intervals not exceeding 5 minutes, using predefined hypotension thresholds (MAP \<75, \<65, and \<55 mmHg).
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)4
Discrimination Performance of pDEP (Respiratory Depression Prediction Index)
Concordance statistic (c-index) comparing continuous pDEP predictions against respiratory effort rate and tidal volume reference standard measurements, using predefined respiratory depression thresholds.
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 outcomes
1
Short-term Predictive Performance of pSED, pNOC, pHYPO, and pDEP at +5-Minute and +10-Minute Prediction Horizons
Concordance statistic (c-index) for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC, evaluated at +5-minute and +10-minute prediction horizons against the same reference standards used in the primary analysis. Performance thresholds and statistical methods are identical to those applied in the primary performance evaluation.
Time frame
From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)2
Threshold-based Discrimination Performance of pSED, pHYPO, and pDEP Against Predefined Binary Clinical Thresholds
AUC-ROC for pSED, pHYPO, and pDEP predictions against binary classifications derived from predefined clinical thresholds (e.g., sedation level categories, hypotension thresholds, respiratory depression criteria)
Time frame
From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)3
Exploratory Subgroup Analyses of Predictive Performance by ASA Physical Status, Age Group, and Sex
Discrimination metrics (c-index or AUC-ROC, as applicable) for each SED Pack predictive index compared across predefined patient subgroups: ASA physical status (I/II vs. III), age group (\<65 vs. ≥65 years), and sex (male vs. female). These analyses are descriptive and exploratory; the study is not powered for inferential subgroup comparisons.
Time frame
From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)Sponsors and contacts
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Source ClinicalTrials.gov