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Completed

NCT Number: NCT03950934

Videolaryngoscopic Intubation and Difficult Airway Classification

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, observational study, perioperative survey

Other

no intervention

Primary outcomes

  1. Difficult videolaryngoscopic intubation

    Time frame: 30 minutes after endotracheal intubation

    Questionnaire

Secondary outcomes

  1. Successful first intubation attempt

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  2. Overall success

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  3. Unsuccessful videolaryngoscopy

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  4. Severity of videolaryngoscopic intubation

    Time frame: 30 minutes after endotracheal intubation

    Numeral rating scale

  5. Specific recommendations of the handling anesthetist

    Time frame: 30 minutes after endotracheal intubation

    Questionnaire

  6. Time to successful intubation

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  7. Number of laryngoscopy and intubation attempts

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  8. Lowest oxygen saturation during airway management

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  9. Initial end-tidal carbon dioxide level after successful intubation

    Time frame: 30 minutes after endotracheal intubation

    Observation during airway management

  10. Observed complications during or after induction of general anesthesia

    Time frame: 30 minutes after endotracheal intubation

    Questionnaire

  11. Length of hospital stay

    Time frame: Until hospital discharge up to 3 months after surgery

    Follow-up

  12. All cause in-hospital mortality

    Time frame: Until hospital discharge up to 3 months after surgery

    Follow-up

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: VIDiAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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