Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Difficult Intubation Clinical Trial

Official title:

Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265938
• Other study ID #: GCO 17-0963
• Status: Completed
• Start date: September 13, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: June 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kramer A, Müller D, Pförtner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC(®) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016. — View Citation

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. — View Citation

Rosenstock CV, Thøgersen B, Afshari A, Christensen AL, Eriksen C, Gätke 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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