SED Pack: Predictive monitoring tool for sedation during GI endoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study conducted at Hospital Clínic de Barcelona to evaluate the safety and performance of the SED Pack medical device software. The software continuously analyzes physiological monitoring data and drug-infusion parameters to generate four real-time risk indices related to sedation depth, motor response, hypotension, and respiratory depression. The study is non-interventional and fully blinded, with data collected during routine procedures using standard care only. Participation is limited to adults scheduled for elective GI endoscopy under propofol and remifentanil with informed consent.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Natalia Estrada Barreras, PhD
• Email: nestrada@predictheon.com
• Phone: 0034 610 32 11 21

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.