Videolaryngoscopic Intubation and Difficult Airway Classification

Oral Surgery Clinical Trial

— VIDiAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950934
• Other study ID #: PV5856
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 1, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maxillofacial Surgery
• Oral Surgery

Intervention

Other:
• no intervention, observational study, perioperative survey
no intervention

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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