University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
NCT Number: NCT03950934
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.
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Notify Me18 year and older
All sexes
Observational
Hamburg, 20246, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
no intervention
Time frame: 30 minutes after endotracheal intubation
Questionnaire
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Numeral rating scale
Time frame: 30 minutes after endotracheal intubation
Questionnaire
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Observation during airway management
Time frame: 30 minutes after endotracheal intubation
Questionnaire
Time frame: Until hospital discharge up to 3 months after surgery
Follow-up
Time frame: Until hospital discharge up to 3 months after surgery
Follow-up
Universitätsklinikum Hamburg-Eppendorf
Other
Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery
Acronym: VIDiAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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