Videolaryngoscopic Intubation and Difficult Airway Classification

Completed

• Conditions: Oral Surgery; Maxillofacial Surgery

• Registration Number: NCT03950934
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Primary Completion: 2020-04-05
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficult videolaryngoscopic intubation	30 minutes after endotracheal intubation	Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany