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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03950934
Acronym
VIDiAC
Enrollment
400
Registered
2019-05-15
Start date
2019-04-01
Completion date
2020-05-01
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofacial Surgery, Oral Surgery

Keywords

Anesthesia, Airway Management, Intubation, Bronchoscopes, Risk Assessment, Surgery

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.

Interventions

OTHERno intervention, observational study, perioperative survey

no intervention

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difficult videolaryngoscopic intubation30 minutes after endotracheal intubationQuestionnaire

Secondary

MeasureTime frameDescription
Overall success30 minutes after endotracheal intubationObservation during airway management
Unsuccessful videolaryngoscopy30 minutes after endotracheal intubationObservation during airway management
Severity of videolaryngoscopic intubation30 minutes after endotracheal intubationNumeral rating scale
Specific recommendations of the handling anesthetist30 minutes after endotracheal intubationQuestionnaire
Time to successful intubation30 minutes after endotracheal intubationObservation during airway management
Successful first intubation attempt30 minutes after endotracheal intubationObservation during airway management
Lowest oxygen saturation during airway management30 minutes after endotracheal intubationObservation during airway management
Initial end-tidal carbon dioxide level after successful intubation30 minutes after endotracheal intubationObservation during airway management
Observed complications during or after induction of general anesthesia30 minutes after endotracheal intubationQuestionnaire
Length of hospital stayUntil hospital discharge up to 3 months after surgeryFollow-up
All cause in-hospital mortalityUntil hospital discharge up to 3 months after surgeryFollow-up
Number of laryngoscopy and intubation attempts30 minutes after endotracheal intubationObservation during airway management

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026