Videolaryngoscopic Intubation and Difficult Airway Classification (VIDiAC)

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Surgery; Maxillofacial Surgery
• Intervention / Treatment: Other: no intervention, observational study, perioperative survey

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ENT or OMF surgical patients presenting at the Anesthesiology Preassessment Clinic of the University Medical Center Hamburg-Eppendorf for preoperative risk assessment will be checked for eligibility. Repeated inclusions of participators are allowed.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Martin Petzoldt, PD Dr., Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): April 5, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (ACTUAL): May 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Airway Management; Anesthesia; Risk Assessment; Intubation; Bronchoscopes
• Other Study ID Numbers: PV5856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No