Videolaryngoscopic Intubation and Difficult Airway Classification

Study Overview
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Brief Summary
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Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.

Detailed Description
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Difficult endotracheal intubation is a major reason for anesthesia related adverse events. Videolaryngoscopy has become an important part of the anesthesiological standard of care for difficult airway management in the past decades. Still, medical preconditions, as well as procedural and technical factors related with difficult videolaryngoscopy have not been systematically investigated, and a standardized comprehensive classification system for the severity of videolaryngoscopic intubation has yet to be specified. The primary objective of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing ENT or OMF surgery. Patients with conditions of the ENT and OMF spectrum have a predisposition for difficult airway management and are at high risk for adverse events during endotracheal intubation. However, current recommendations for preoperative screening for difficult intubation rarely consider space consuming lesions of the laryngopharyngeal region. Comprehensive data identifying the predictive value of preoperative flexible nasal videoendoscopy as a diagnostic measure to anticipate difficult airway management still lack. Thus, secondary aim of this study is to evaluate the diagnostic value and clinical significance of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients. Study design: The investigators conduct a prospective observational study, which includes 400 patients with predicted difficult airway and confirmed indication for flexible nasal videoendoscopy and videolaryngoscopic intubation undergoing ENT or OMF surgery. Procedural and surgical data as well as medical preconditions will be assessed systematically. The handling anesthetist and two independent observers will be surveyed (structured questionnaire) in order to assess procedural and technical factors related with videolaryngoscopic intubation.

Official Title
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Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery

Conditions
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Oral Surgery, Maxillofacial Surgery

Intervention / Treatment
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* Other: no intervention, observational study, perioperative survey


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 18 Years and older Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation Exclusion criteria: No consent given Pregnancy

Ages Eligible for Study
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Minimum 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention, observational study, perioperative survey|no intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficult videolaryngoscopic intubation | Questionnaire | 30 minutes after endotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful first intubation attempt | Observation during airway management | 30 minutes after endotracheal intubation | 
| Overall success | Observation during airway management | 30 minutes after endotracheal intubation | 
| Unsuccessful videolaryngoscopy | Observation during airway management | 30 minutes after endotracheal intubation | 
| Severity of videolaryngoscopic intubation | Numeral rating scale | 30 minutes after endotracheal intubation | 
| Specific recommendations of the handling anesthetist | Questionnaire | 30 minutes after endotracheal intubation | 
| Time to successful intubation | Observation during airway management | 30 minutes after endotracheal intubation | 
| Number of laryngoscopy and intubation attempts | Observation during airway management | 30 minutes after endotracheal intubation | 
| Lowest oxygen saturation during airway management | Observation during airway management | 30 minutes after endotracheal intubation | 
| Initial end-tidal carbon dioxide level after successful intubation | Observation during airway management | 30 minutes after endotracheal intubation | 
| Observed complications during or after induction of general anesthesia | Questionnaire | 30 minutes after endotracheal intubation | 
| Length of hospital stay | Follow-up | Until hospital discharge up to 3 months after surgery | 
| All cause in-hospital mortality | Follow-up | Until hospital discharge up to 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Airway Management, Intubation, Bronchoscopes, Risk Assessment, Surgery