Observational Study of SED Pack Softwares Safety and Accuracy for Predictive Monitoring During Sedation in Adults Undergoing Gastrointestinal Endoscopy

What this Trial Is About

Researchers are evaluating the clinical performance and safety of SED Pack, a Medical Device Software designed to support monitoring during procedural sedation in adults undergoing gastrointestinal endoscopy. The study is observational and non-interventional, conducted at a single center in Spain. It aims to assess how well the softwares predictive indices can anticipate sedation depth, response to stimuli, hypotension, and respiratory depression compared to standard monitoring methods. SED Pack processes physiological and drug-infusion data in real time to generate four predictive indices updated every second sedation depth pSED, likelihood of response to noxious stimuli pNOC, risk of arterial hypotension pHYPO, and risk of respiratory depression pDEP. The software runs in a fully blinded mode during routine sedation procedures, without influencing clinical care. No extra procedures are added beyond standard sedation with propofol and remifentanil administered via target-controlled infusion. Participants will undergo their scheduled endoscopic procedures with standard monitoring, while the software collects data continuously during sedation sessions lasting about 20 to 60 minutes. Researchers will analyze the softwares prediction accuracy using statistical measures such as the c-index and AUC-ROC. The study includes performance evaluations at different time horizons and subgroup analyses by physical status, age, and sex. Participation is voluntary, with no extra risks or interventions, and the study complies with relevant medical device regulations.

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