Difficult Intubation
Conditions
Keywords
Head and Neck cancer, Cancer of oral cavity, Ear, Nose and Throat, Indirect laryngoscopy, Awake intubation, Expected difficult intubation
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.
Interventions
DEVICEIndirect 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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 |
Countries
United States
Participant flow
Recruitment details
study was conducted from September 2017 until July 2019
Participants by arm
| Arm | Count |
|---|---|
| Indirect Laryngoscopy Head and neck pathology patients undergoing indirect laryngoscopy. 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. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | friable mass | 6 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Indirect Laryngoscopy | — |
|---|---|---|
| Age, Continuous | 65 years | — |
| Body Mass Index (BMI) | 23.79 kg/m^2 | — |
| Edentulous | 25 Participants | — |
| Head and Neck Mass Location Base of Tongue | 23 Participants | — |
| Head and Neck Mass Location Laryngeal | 10 Participants | — |
| Head and Neck Mass Location Neck | 11 Participants | — |
| Head and Neck Mass Location None | 45 Participants | — |
| Head and Neck Mass Location Supraglottic | 11 Participants | — |
| History of Head and Neck Surgery | 49 Participants | — |
| History of Radiation Therapy | 69 Participants | — |
| Mallampati score 1 | 8 Participants | — |
| Mallampati score 2 | 32 Participants | — |
| Mallampati score 3 | 24 Participants | — |
| Mallampati score 4 | 36 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 75 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 92 |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
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
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Indirect Laryngoscopy | Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade | 37 Participants |
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
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Indirect Laryngoscopy | Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL | 28 Participants |
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.
Time frame: Day 1
Population: Data for participants who have a history of head and neck masses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade | Grade 1 | 11 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade | Grade 2a | 10 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade | Grade 2b | 8 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade | Grade 3 | 4 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade | Grade 4 | 15 Participants |
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.
Time frame: Day 1
Population: Data for participants who have a history of head and neck masses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL | Grade 1 | 19 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL | Grade 2a | 5 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL | Grade 2b | 10 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL | Grade 3 | 2 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL | Grade 4 | 12 Participants |
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.
Time frame: Day 1
Population: Data for participants who have a history of neck radiation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade | Grade 1 | 18 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade | Grade 2a | 10 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade | Grade 2b | 9 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade | Grade 3 | 6 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade | Grade 4 | 23 Participants |
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.
Time frame: Day 1
Population: Data for participants who have a history of neck radiation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL | Grade 1 | 26 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL | Grade 2a | 11 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL | Grade 2b | 9 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL | Grade 3 | 5 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL | Grade 4 | 15 Participants |
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
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With CMAC D Blade | Grade 1 | 23 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With CMAC D Blade | Grade 2a | 19 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With CMAC D Blade | Grade 2b | 13 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With CMAC D Blade | Grade 3 | 8 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With CMAC D Blade | Grade 4 | 29 Participants |
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
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With Glidescope AVL | Grade 1 | 37 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With Glidescope AVL | Grade 2a | 14 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With Glidescope AVL | Grade 2b | 13 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With Glidescope AVL | Grade 3 | 6 Participants |
| Indirect Laryngoscopy | Cormack-Lehane Grade Obtained With Glidescope AVL | Grade 4 | 22 Participants |