Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Completed

• Conditions: Difficult Intubation
• Interventions: Device: Indirect Laryngoscopy

• Registration Number: NCT03265938
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Study Start: 2017-09-13
• Primary Completion: 2019-07-24
• Study Completion: 2019-07-24
• Status Verified: 2020-06
• Results First Submitted: 2020-06-01
• Results First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-15
• Results First Posted: 2020-06-16
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Emergency Procedure
• Presence of one or more loose teeth

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indirect laryngoscopy	Indirect Laryngoscopy	Head and neck pathology patients undergoing indirect laryngoscopy. Patients with a past medical history of active or previously treated head and neck pathology.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL	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
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade	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

Secondary Outcome Measures

Name	Time	Method
Cormack-Lehane Grade Obtained With CMAC D Blade	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
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL	Day 1	Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade	Day 1	Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL	Day 1	Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Cormack-Lehane Grade Obtained With Glidescope AVL	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
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade	Day 1	Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States