- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06617403
Pre-operative Characteristics for Prediction of Supraglottic Airway Failure Using Machine Learning (ERICA) (ERICA)
Can Pre-operative Characteristics Predict Failure of Supraglottic Airway to Tracheal Tube? A Machine Learning Algorithm (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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Baden-Wurttemberg
-
Ulm, Baden-Wurttemberg, Germany, 89073
- University Hospital Ulm
-
-
Bavaria
-
Munich, Bavaria, Germany, 81675
- Technical University Munich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥18 years) receiving general anaesthesia for non-cardiac surgery with a supraglottic airway device
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Risk of unplanned SGA conversion
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERICA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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