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Can AI predict complications before they happen during sedation?

NCT ID NCT07749781

Knowledge-focused Sponsor: Predictheon Medical, S.L. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests whether a software tool called SED Pack can accurately predict sedation depth, pain response, low blood pressure, and breathing problems during routine endoscopic procedures. The software runs in the background, analyzing patient monitoring data in real time, but its predictions are not shown to doctors. The goal is to see if the predictions are accurate enough to potentially help prevent complications in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SED Pack, a medical device software that analyzes monitoring data to predict sedation-related complications
What this could lead to
If successful, this software could help doctors anticipate and prevent dangerous drops in blood pressure or breathing problems during sedation, making procedures safer.
What could go wrong
This is an early observational study, so the software's predictions may not be accurate enough in real-world settings. It is not yet proven to improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal endoscopy Procedural sedation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

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