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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: Indirect Laryngoscopy

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all patients scheduled to undergo a surgical procedure at the Mount Sinai Hospital (New York, NY)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Indirect Laryngoscopy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade	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	Day 1
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL	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	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Jaime Hyman, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
• Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
• Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
• Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.
• Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. No abstract available.
• Rosenstock CV, Thogersen B, Afshari A, Christensen AL, Eriksen C, Gatke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012 Jun;116(6):1210-6. doi: 10.1097/ALN.0b013e318254d085.
• Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to determine the future. Anesthesiology. 2012 Jun;116(6):1181-2. doi: 10.1097/ALN.0b013e318254d0a0. No abstract available.
• Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in obstetric patients: a survey of anaesthetists in the Oxford region. Int J Obstet Anesth. 2000 Apr;9(2):78-82. doi: 10.1054/ijoa.1999.0361.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Head and Neck cancer; Cancer of oral cavity; Ear, Nose and Throat; Indirect laryngoscopy; Awake intubation; Expected difficult intubation
• Other Study ID Numbers: GCO 17-0963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes