NCT03950934

Videolaryngoscopic Intubation and Difficult Airway Classification

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Oral Surgery
• Maxillofacial Surgery

Interventions

Type	Name	Description
OTHER	no intervention, observational study, perioperative survey	no intervention

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-04-05
• Completion: 2020-05-01
• First posted: 2019-05-15
• Last updated: 2020-05-29

Locations

1 site across 1 country: Germany