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Completed

NCT Number: NCT06617403

Pre-operative Characteristics for Prediction of Supraglottic Airway Failure Using Machine Learning (ERICA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ulm, Ulm, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

non

Other

non

Primary outcomes

  1. Risk of unplanned SGA conversion

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

University Hospital Ulm

Other

Collaborators

  • Technical University of Munich

Registry information

Official study title

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

Acronym: ERICA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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