Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification — PeDiAC  

Anesthesia Clinical Trial

Official title: Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Status Completed

Clinical Trial Summary

The study's primary aim is to develop and validate a multivariable diagnostic model for the prediction of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification.

Clinical Trial Description

Difficult tracheal intubation is one of the major reasons for anesthesia-related adverse events. Videolaryngoscopy has become an important part of the anesthesiology standard of care for difficult airway management in the past decades. This is especially relevant in children, as their airway anatomy differs greatly from adults because they are likely incapable of tolerating brief apneic episodes. Still, medical preconditions and procedural and technical factors related to difficult videolaryngoscopy have not been broadly investigated and not fully been understood.

The primary aim of the PeDiAC study is to develop and validate a multivariable diagnostic model for the classification of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. Study planning and conduction are in accordance with the TRIPOD 'Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis' statement. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification, which is the current clinical standard for assessing intubation via direct laryngoscopy. We conduct a prospective observational study that will include approximately 800 pediatric patients within one year scheduling for tracheal intubation. Patients with age below 18 years will be considered to be eligible for inclusion. Procedural and surgical data, as well as medical preconditions, will be assessed systematically. After tracheal intubation, performed by the responsible anesthetist, the intubation process will be rated by the responsible anesthetist and an additional independent observer, and detailed information regarding procedural and technical factors related to videolaryngoscopy will be documented. All sampled independent variables will be considered to be potential candidate predictors for the multivariable regression model. ;

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Airway Management
• Anesthesia
• Intubation;Difficult
• Laryngoscopy

• NCT number: NCT04844723
• Study type: Observational
• Source: Universitätsklinikum Hamburg-Eppendorf
• Status: Completed
• Start date: April 12, 2021
• Completion date: August 3, 2022