Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Conditions
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Anesthesia, Airway Complication of Anesthesia, Intubation;Difficult, Laryngoscopy, Airway Management

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center. Informed consent obtained Age < 18 years Exclusion Criteria: Anesthetist prefers conventional laryngoscopy Indication for intubation via a bronchoscope or awake intubation

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficult videolaryngoscopic intubation | Rating by the responsible anesthetist | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass success rate | Percentage of successful intubations with one attempt | 1 hour | 
| Overall success rate with the first-choice technique | Percentage of successful intubations without transition to another technique | 1 hour | 
| Number of attempts | Total number of laryngoscopy and intubation attempts until airway established | 1 hour | 
| Change of airway technique | Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No) | 1 hour | 
| Best glottic view | Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV) | 1 hour | 
| Time to best view | Time until optimal view conditions during laryngoscopy | 1 hour | 
| Intubation time | Time until successful tracheal intubation | 1 hour | 
| Intubation difficulty, ease of intubation and quality of visualisation | Subjective ratings on visual analogue scales (0 to 100 with 0 being the best) | 1 hour | 
| Post-intubation recommendation for an intubation method | Requirement of recommendation for further intubations of the responsible anesthetist | 1 hour | 
| Post-intubation recommendation for an anesthesia alert cart | Recommendation of the responsible anesthetist (yes/no) | 1 hour | 
| Post-intubation diagnosis of 'difficult intubation' | Rating of the responsible anesthetist | 1 hour | 
| Airway-related adverse events | Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia | 1 hour | 
| Difficult bag-mask ventilation | As clinically assessed (yes/no) by the responsible anesthetist | 1 hour | 
| Lowest oxygen saturation | Measured with pulsoxymetry during anesthesia | 1 hour | 
| Hypercapnia | Measured endtidal carbon dioxide after successful intubation | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Airway management, Videolaryngoscopy, Endotracheal Intubation, Difficult Intubation