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Completed

NCT Number: NCT03265938

Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced.

Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy.

Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this patient population, it will reinforce that anesthesiologists need to continue to learn and maintain skills in bronchoscopic intubation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age> 18 years old
  • Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for head and neck cancer
  • Requiring awake flexible bronchoscopic intubation for surgery
  • Willing and able to provide informed consent

Exclusion criteria

  • Emergency Procedure
  • Presence of one or more loose teeth

Treatment and study plan

Indirect Laryngoscopy

Device

The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.

Other names: Glidescope AVL Indirect Laryngoscopy, C-MAC D-Blade Indirect Laryngoscopy

Primary outcomes

  1. Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade

    Time frame: Day 1

    Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC

    Cormack-Lehane grade in patients with head and neck pathology of the larynx.

    Cormack-Lehane grade:

    Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

  2. Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL

    Time frame: Day 1

    Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL

    Cormack-Lehane grade in patients with head and neck pathology of the larynx.

    Cormack-Lehane grade:

    Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

Secondary outcomes

  1. Cormack-Lehane Grade Obtained With CMAC D Blade

    Time frame: Day 1

    Cormack-Lehane grade in patients with head and neck pathology of the larynx.

    Cormack-Lehane grade:

    Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

  2. Cormack-Lehane Grade Obtained With Glidescope AVL

    Time frame: Day 1

    Cormack-Lehane grade in patients with head and neck pathology of the larynx.

    Cormack-Lehane grade:

    Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

  3. Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade

    Time frame: Day 1

    Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.

  4. Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL

    Time frame: Day 1

    Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.

  5. Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade

    Time frame: Day 1

    Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.

  6. Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL

    Time frame: Day 1

    Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Jul 2, 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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