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Clinical Trials/NCT06617403
NCT06617403
Active, not recruiting
Not Applicable

Can Pre-operative Characteristics Predict Failure of Supraglottic Airway to Tracheal Tube? A Machine Learning Algorithm (ERICA)

University Hospital Ulm2 sites in 1 country44,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
University Hospital Ulm
Enrollment
44000
Locations
2
Primary Endpoint
Risk of unplanned SGA conversion
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Supraglottic airway devices (SGA) are a safe and well-established technique for airway management. Nowadays, up to 60% of general anaesthetics performed in European countries use SGA. In 0.2-4.7% SGA fail and require conversion to tracheal tubes.

The ERICA study will use artificial intelligence methods to develop a model that can predict the risk of an unplanned SGA conversion based on pre-operative characteristics available during the premedication visit.

Detailed Description

An intraoperative change of procedure not only leads to time delays but also time delays, but also involves measures that are stressful for the patient, such as deepening the anaesthesia and manipulating the airway again. Therefore, the objective of ERICA is to develop a machine learning algorithm based on preoperative information 1) that can accurately predict the risk of an unplanned SGA conversion and 2) identifies characteristics leading to conversion from SGA to tracheal tube. I. Developing the model • The final dataset will be split in a training, testing, and validation cohort. Five models will be created to predict intraoperative conversion from SGA to tracheal tube including generalized linear models (GLM), deep learning, distributed random forest (DRF), xgboost and gradient boosting machine (GBM). Then, a stacked ensemble model will be constructed through combination of the five models. Finally, the best artificial intelligence model will be chosen. II. Identify characteristics leading to the airway conversion and categorisation. * Intraoperative changes of the patient's position can alter the risk of conversion, therefore operations with positional changes should be considered * Identify patient- and procedure-dependent characteristics that lead to conversion from SGA to tracheal tube and their importance.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Ulm
Responsible Party
Principal Investigator
Principal Investigator

Flora Scheffenbichler

Dr. med.

University Hospital Ulm

Eligibility Criteria

Inclusion Criteria

  • Adult patients (≥18 years) receiving general anaesthesia for non-cardiac surgery with a supraglottic airway device

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Risk of unplanned SGA conversion

Time Frame: intraoperative

Study Sites (2)

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