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Not yet recruitingNCT07536230Updated Apr 17, 2026

Deep Learning Framework for Continuous Depth of Anesthesia Forecasting

An observational study in BIS, BIS-EEG and Artifical Intelligence, sponsored by Universitair Ziekenhuis Brussel. Not yet recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
115
Sex
All
01

Study summary

The integration of Artificial Intelligence (AI) in anesthesiology offers the potential to shift patient monitoring from reactive to predictive. Deep learning architectures, specifically Long Short-Term Memory (LSTM) networks, excel at processing complex, time-series data to forecast future clinical states.

While standard PK/PD models (such as the state of the art Eleveld model for Propofol and Remifentanil) estimate target-site drug concentrations (Ce), they do not account for real-time, patient-specific dynamic responses. This study aims to deploy an AI framework designed to predict future physiological states.

02

Conditions studied

  • BIS
  • BIS-EEG
  • Artifical Intelligence
  • Intraoperative
  • Machine Learning
  • Anesthesia
  • Anesthesia Awareness
  • Predictive Model
03

In context

Intraoperative Awareness

51 studies on the registry are indexed under Intraoperative Awareness; 7 are open to participants now.

This study's planned enrollment of 115 is close to the median of 108 across 26 observational studies indexed under Intraoperative Awareness.

Browse Intraoperative Awareness studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients undergoing general anesthesia under continuous depth of anesthesia monitoring.

Inclusion criteria

  • Patients scheduled for elective surgery requiring general anesthesia.
  • Procedures requiring continuous depth of anesthesia monitoring (BIS).

Exclusion criteria

Exclusion Criteria:

- Procedures where the primary anesthetic plan does not involve continuous electronic data capture.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
115 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Prospective

    Prospective Cohort

  • Restrospective

    Retrospective Cohort

06

What researchers measure

Primary outcomes

  1. Calibration error of the predictive uncertainty cone

    Calibration error of the predictive uncertainty cone - Calibration error of the predictive uncertainty cone is the discrepancy between a model's stated confidence level (e.g., predicting that 95% of future values will fall within a specific range) and the actual frequency with which the true values actually land inside that predicted boundary.

    Time frame: Continuous - Perioperative

  2. Mean Absolute Error (MAE)

    Mean Absolute Error (MAE)

    Time frame: Continuous - perioperative

  3. Trend accuracy

    Trend accuracy measures a predictive model's ability to correctly forecast the future direction and rate of change of a variable (such as whether a patient's anesthesia depth is actively lightening or deepening), independent of the absolute numerical error at any single point in time.

    Time frame: Continuous - perioperative

Secondary outcomes

  1. Root Mean Square Error (RMSE)

    Root Mean Square Error (RMSE)

    Time frame: Continuous - perioperative

07

Study locations

1 site
  • AZ Sint-Jan AV
    Bruges, 8000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07536230
Lead sponsor
Universitair Ziekenhuis Brussel
Collaborators
AZ Sint-Jan AV
Responsible party
Sponsor
First posted
Apr 17, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Apr 17, 2026

Study contacts

Hugo Carvalho, MD, PhD
Contact
hugo.nogueiracarvalho@azsintjan.be
+32 50 45 24 19

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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