Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

NCT03265938 | Completed Results FDA Device

• 1 other identifier: GCO 17-0963
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Intubation

Keywords

Head and Neck cancer; Cancer of oral cavity; Ear, Nose and Throat; Indirect laryngoscopy; Awake intubation; Expected difficult intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Cormack-Lehane Grade Obtained With CMAC D Blade

  Day 1

• Cormack-Lehane Grade Obtained With Glidescope AVL

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

Study Arms (1)

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

Interventions

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.

Also known as: Glidescope AVL Indirect Laryngoscopy, C-MAC D-Blade Indirect Laryngoscopy

Indirect laryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Emergency Procedure
• Presence of one or more loose teeth

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (8)

• 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.

  PMID: 23364566 BACKGROUND

• 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.

  PMID: 26684527 BACKGROUND

• 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.

  PMID: 25764403 BACKGROUND

• 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.

  PMID: 22487805 BACKGROUND

• 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.

  PMID: 21150569 BACKGROUND

• 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.

  PMID: 21447488 BACKGROUND

• 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.

  PMID: 22487804 BACKGROUND

• 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.

  PMID: 15321093 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

This study was not a comparison between awake techniques. Laryngoscopy conditions may be different after an endotracheal tube is already in place and the patient is anesthetized. The results cannot be generalized to other available types.

Results Point of Contact

• Title: Dr. Samuel DeMaria
• Organization: Icahn School of Medicine at Mount Sinai

samuel.demaria@mountsinai.org

(212) 241-1518

Study Officials

• Jaime Hyman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: September 13, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: July 2, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)