Clinical trial NCT03950934: Videolaryngoscopic Intubation and Difficult Airway Classification
Official title: Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Surgery
Maxillofacial Surgery
Keywords: Anesthesia
Airway Management
Intubation
Bronchoscopes
Risk Assessment
Surgery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difficult videolaryngoscopic intubation
timeFrame: 30 minutes after endotracheal intubation
Secondary outcomes:
measure: Successful first intubation attempt
timeFrame: 30 minutes after endotracheal intubation
measure: Overall success
timeFrame: 30 minutes after endotracheal intubation
measure: Unsuccessful videolaryngoscopy
timeFrame: 30 minutes after endotracheal intubation
measure: Severity of videolaryngoscopic intubation
timeFrame: 30 minutes after endotracheal intubation
measure: Specific recommendations of the handling anesthetist
timeFrame: 30 minutes after endotracheal intubation
measure: Time to successful intubation
timeFrame: 30 minutes after endotracheal intubation
measure: Number of laryngoscopy and intubation attempts
timeFrame: 30 minutes after endotracheal intubation
measure: Lowest oxygen saturation during airway management
timeFrame: 30 minutes after endotracheal intubation
measure: Initial end-tidal carbon dioxide level after successful intubation
timeFrame: 30 minutes after endotracheal intubation
measure: Observed complications during or after induction of general anesthesia
timeFrame: 30 minutes after endotracheal intubation
measure: Length of hospital stay
timeFrame: Until hospital discharge up to 3 months after surgery
measure: All cause in-hospital mortality
timeFrame: Until hospital discharge up to 3 months after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
name: Martin Petzoldt, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: