Trial Outcomes & Findings for Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology (NCT NCT03265938)
NCT ID: NCT03265938
Last Updated: 2020-07-02
Results Overview
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
COMPLETED
100 participants
Day 1
2020-07-02
Participant Flow
study was conducted from September 2017 until July 2019
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
friable mass
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Indirect Laryngoscopy
n=100 Participants
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.
|
|---|---|
|
Age, Continuous
|
65 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=100 Participants
|
|
Body Mass Index (BMI)
|
23.79 kg/m^2
n=100 Participants
|
|
History of Head and Neck Surgery
|
49 Participants
n=100 Participants
|
|
History of Radiation Therapy
|
69 Participants
n=100 Participants
|
|
Edentulous
|
25 Participants
n=100 Participants
|
|
Mallampati score
1
|
8 Participants
n=100 Participants
|
|
Mallampati score
2
|
32 Participants
n=100 Participants
|
|
Mallampati score
3
|
24 Participants
n=100 Participants
|
|
Mallampati score
4
|
36 Participants
n=100 Participants
|
|
Head and Neck Mass Location
None
|
45 Participants
n=100 Participants
|
|
Head and Neck Mass Location
Base of Tongue
|
23 Participants
n=100 Participants
|
|
Head and Neck Mass Location
Supraglottic
|
11 Participants
n=100 Participants
|
|
Head and Neck Mass Location
Neck
|
11 Participants
n=100 Participants
|
|
Head and Neck Mass Location
Laryngeal
|
10 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Day 1Number 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
Outcome measures
| Measure |
Indirect Laryngoscopy
n=92 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade
|
37 Participants
|
PRIMARY outcome
Timeframe: Day 1Number 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
Outcome measures
| Measure |
Indirect Laryngoscopy
n=92 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 1Cormack-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
Outcome measures
| Measure |
Indirect Laryngoscopy
n=92 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade Obtained With CMAC D Blade
Grade 1
|
23 Participants
|
|
Cormack-Lehane Grade Obtained With CMAC D Blade
Grade 2a
|
19 Participants
|
|
Cormack-Lehane Grade Obtained With CMAC D Blade
Grade 2b
|
13 Participants
|
|
Cormack-Lehane Grade Obtained With CMAC D Blade
Grade 3
|
8 Participants
|
|
Cormack-Lehane Grade Obtained With CMAC D Blade
Grade 4
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 1Cormack-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
Outcome measures
| Measure |
Indirect Laryngoscopy
n=92 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade Obtained With Glidescope AVL
Grade 1
|
37 Participants
|
|
Cormack-Lehane Grade Obtained With Glidescope AVL
Grade 2a
|
14 Participants
|
|
Cormack-Lehane Grade Obtained With Glidescope AVL
Grade 2b
|
13 Participants
|
|
Cormack-Lehane Grade Obtained With Glidescope AVL
Grade 3
|
6 Participants
|
|
Cormack-Lehane Grade Obtained With Glidescope AVL
Grade 4
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Data for participants who have a history of head and neck masses.
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
Outcome measures
| Measure |
Indirect Laryngoscopy
n=48 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Grade 1
|
11 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Grade 2a
|
10 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Grade 2b
|
8 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Grade 3
|
4 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Grade 4
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Data for participants who have a history of head and neck masses.
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
Outcome measures
| Measure |
Indirect Laryngoscopy
n=48 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Grade 1
|
19 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Grade 2a
|
5 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Grade 2b
|
10 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Grade 3
|
2 Participants
|
|
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Grade 4
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Data for participants who have a history of neck radiation
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Outcome measures
| Measure |
Indirect Laryngoscopy
n=66 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Grade 1
|
18 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Grade 2a
|
10 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Grade 2b
|
9 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Grade 3
|
6 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Grade 4
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Data for participants who have a history of neck radiation.
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Outcome measures
| Measure |
Indirect Laryngoscopy
n=66 Participants
Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.
|
|---|---|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Grade 1
|
26 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Grade 2a
|
11 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Grade 2b
|
9 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Grade 3
|
5 Participants
|
|
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Grade 4
|
15 Participants
|
Adverse Events
Indirect Laryngoscopy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Samuel DeMaria
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place