Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology
Conditions: Difficult Intubation
Sponsor: Icahn School of Medicine at Mount Sinai

Evaluation of Video Laryngoscopy in Patients with Head and Neck Pathology 
Jaime Hyman, MD 
NCT03265938 
3-13-2018

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
1 
Revised  9/2/14 
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Brief Summary of Research (250-400 words): 
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. Video 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
2 
Revised  9/2/14 
laryngoscopy may be more prone to failure in this patient population, and randomizing 
this population to video laryngoscopy would pose too great a risk.  
 
If results of previous studies are erroneously generalized, anesthesiologists’ skills in 
flexible bronchoscopy will decline. We therefore propose to 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. This will 
allow us to approximate what the laryngeal view would have been with video 
laryngoscopy. 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. 
 
Objectives: 
Research Question: In patients with predicted difficult airways due to head and 
neck pathology (malignancy or a history of surgery or radiation therapy) who 
undergo awake bronchoscopic intubation, what proportion would have been 
possible to intubate with video laryngoscopy? 
Hypothesis: A significant proportion of patients with head and neck 
pathology will have poor laryngeal views with post-induction video 
laryngoscopy by experienced anesthesiologists.  
Primary objective: Determine the incidence of difficult (Cormack-Lehane 
grade >2) video laryngoscopic view of the larynx after awake flexible 
bronchoscopic intubation in patients with head and neck pathology 
 
Secondary objectives: 
a) grade the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with head 
and neck pathology 
b) grade the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with head 
and neck masses 
c) grade the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with a history 
of neck radiation 
 
. 
1) 
Background 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
3 
Revised  9/2/14 
 
Awake flexible bronchoscopic intubation is considered the gold standard in the 
management of the anticipated difficult airway.1 More recently, this has been called into 
question,2 with alternative intubation techniques described in both asleep and awake 
patients. In particular, many have advocated the use of awake video laryngoscopy.3,4 
However, these studies did not include patients with head and neck pathology such as 
airway masses or previous neck radiation.  
 
Advantages cited for videolaryngoscopy include faster intubation time, less training 
required to gain and maintain skills, creation of space within the airway to suction 
secretions, view of the tracheal tube during intubation of the larynx (as opposed to blind 
“railroading” of the tube over the bronchoscope), lower cost, and easier maintenance of 
equipment. Disadvantages of videolaryngoscopy include possible increased risk of failure 
due to gag reflex unable to be attenuated with topical anesthesia, inability to use with 
very limited mouth opening, and inability to move around fixed lesions. While video 
laryngoscopy has a well-established role in management of the difficult airway, it does 
have recognized limitations and failures. There appears to be an increased risk of failure 
of video laryngoscopy in patients with airway masses, neck pathology, and neck 
radiation5 plausibly because a flexible scope would be required to move around immobile 
tissues. Neither direct nor indirect video laryngoscopy can accomplish this necessary 
flexibility. Randomizing this patient population, for whom awake flexible bronchoscopic 
intubation is the gold standard, to other techniques would be unsafe, as multiple 
laryngoscopies can increase the difficulty of airway management. As these patients have 
been excluded from previous randomized studies, the results of these studies cannot be 
generalized to the head and neck pathology patient population. This study aims to assess 
the utility of video laryngoscopy in this patient population by performing a video 
laryngoscopy after the endotracheal tube is safely secured by awake bronchoscopy to get 
an estimate of what the laryngeal view would have been had awake video laryngoscopy 
been used for the intubation. While laryngoscopy conditions are not identical after an 
endotracheal tube is already in place and the patient is anesthetized, it is the most 
appropriate study design to ensure safety in this patient population. 
 
If we find a significant number of difficult video laryngoscopies in this patient 
population, it will reinforce the need for anesthesiologists to maintain skills in flexible 
bronchoscopic intubation. Despite clear clinical indication and a good safety and success 
profile, experienced anesthesiologists may incorrectly forego awake bronchoscopic 
intubation. Qualitative analysis of cases in the United Kingdom’s Royal College of 
Anaesthetists’ 4th National Audit Project (NAP4) revealed elements of poor airway 
management in >75% of reports. Upper airway malignancy or disease processes of the 
head and neck were present in 40% of cases presented to NAP4. The report found 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
4 
Revised  9/2/14 
numerous cases where awake intubation was indicated but not used, possibly due to poor 
judgment, lack of skills, or lack of equipment.6  
 
Bronchoscopy skills are challenging to attain and are prone to decay, potentially leading 
to practitioner discomfort with awake flexible bronchoscopy if not continually 
practiced.7,8 This study aims to add to the current body of knowledge regarding the use of 
video laryngoscopy for the predicted difficult airway, specifically in the head and neck 
pathology patient population. Unlike previous publications, this study will provide a safe 
way to evaluate the use of video laryngoscopy in patients with head and neck malignancy 
and/ or previous head and neck surgery or radiation. Information from this study will help 
guide future strategies in difficult airway management. Our hypothesis is that the 
anatomy in this patient population does not lend itself to straightforward video 
laryngoscopy, and that flexible bronchoscopy continues to have a vital role in the 
management of these airways. 
 
2) 
Setting of the Human Research 
This study will be conducted at the Icahn School of Medicine at Mount 
Sinai at 1468 Madison Avenue in the 7th floor Annenberg Building 
operating rooms. Consent will be obtained in the preoperative holding 
area, and the study protocol will occur in the operating room in which the 
patient is assigned. 
3) 
Resources Available to Conduct the Human Research 
100 participants will be enrolled in this study. Between 3-10 awake 
intubations with a flexible bronchoscope are performed per week in 
patients with head and neck pathology coming to the Annenberg 7 
operating rooms. Assuming conservatively that we can enroll 1-2 patients 
per week, we anticipate completing the study within two years after 
initiation. 
Drs. Demaria, Levine, and Hyman are attending anesthesiologists with 
substantial experience in supervising and performing awake flexible 
bronchoscopic intubations and post-induction video laryngoscope 
intubations. We also each have previous experience with research 
involving ENT surgical patients in the same practice setting, and well-
established professional relationships with our ENT surgical and nursing 
colleagues to help support the study. 
Prior to initiating this study, all participating investigators and support 
staff will conduct a protocol initiation meeting to ensure adequate 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
5 
Revised  9/2/14 
knowledge of the study objectives, procedures, populations, and human 
subject protections. A log of meeting attendees will be maintained. 
 
4) 
Study Design 
a) Recruitment Methods 
Patients who are determined to require an awake flexible bronchoscopic 
intubation by the anesthesiologist caring for the patient on the day of surgery will 
be invited to participate in the study. After preoperative evaluation and 
explanation of the anesthetic plan and the awake flexible bronchoscopic 
intubation, the study will be explained in detail to the patient. All questions will 
be answered and if the patient agrees to participate, written informed consent will 
be obtained prior to entry into the operating room. 
b) Inclusion and Exclusion Criteria 
Inclusion criteria: 
1. Age ≥ 18 years 
2. Presence of oral, pharyngeal or laryngeal mass or history of 
surgery or radiation for head and neck cancer 
3. Requiring awake flexible bronchoscopic intubation for surgery 
4. Willing and able to provide informed consent 
 
Exclusion criteria: 
1. Emergency procedure 
2. Presence of one or more loose teeth 
 
c) Number of Subjects 
100 subjects will be included in this study.  
d) Study Timelines 
Patients will be screened and consented on the day of surgery. The awake 
bronchoscopic intubation and asleep video laryngoscopy will be 
performed prior to the start of surgery. All patients will be seen in the 
hospital (or called at home postoperatively for ambulatory surgical 
patients) within 48 hours to assess for any delayed complications. As 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
6 
Revised  9/2/14 
patients only need to be followed for a maximum of 48 hours after 
discharge to be assessed for all primary and secondary endpoints, we 
estimate the study will be complete within 2 weeks of final patient 
enrollment. 
 
e) Study Endpoints 
Primary objective: Determine the incidence of difficult (Cormack-Lehane 
grade >2) video laryngoscopic view of the larynx after awake flexible 
bronchoscopic intubation in patients with head and neck pathology. 
 
Secondary objectives: 
a) grade the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with head 
and neck pathology 
b) grade the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with head 
and neck masses 
c) grade  the view (Cormack-Lehane) obtained by video laryngoscopy 
after awake flexible bronchoscopic intubation in patients with a history 
of neck radiation 
Subjects will be withdrawn from the study and video laryngoscopy will 
not be performed if the awake flexible bronchoscopy fails and the patient 
cannot be intubated, or if there is difficulty with the awake flexible 
bronchoscopy resulting in tissue trauma. 
f) Procedures Involved in the Human Research 
Patients who are undergoing non-emergency surgery who have a history 
of head and neck pathology (masses, previous surgery, and/or radiation) 
who as determined by the anesthesiologist caring for the patient must 
undergo awake flexible bronchoscopic intubation will be invited to 
participate in the study after preoperative evaluation prior to entry into the 
operating room. Once in the operating room, intravenous access will be 
obtained and American Society of Anesthesiologists’ standard monitors 
(pulse oximeter, electrocardiogram tracing, blood pressure cuff) will be 
applied. The patient will receive glycopyrrolate 0.2mg-0.4mg and sedation 
as per the usual practice of the anesthesiologist. Airway topicalization 
with lidocaine and awake flexible bronchoscopic intubation will be 
performed. After the tracheal tube is secured and general anesthesia is 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
7 
Revised  9/2/14 
induced, the attending anesthesiologist will perform video laryngoscopy 
with the C-MAC D video laryngoscope and with the GlideScope AVL 
video layryngoscope and grade the view of the larynx obtained with each 
laryngoscope. Care will be taken to minimize tissue trauma and 
hemodynamic perturbations caused by video laryngoscopy. All patients 
will receive 10mg of intravenous dexamethasone to reduce airway edema.  
All participants will be monitored by the anesthesia team throughout the 
surgical procedure and until handoff of care to the Post-Anesthesia Care 
Unit (PACU) nurse as per usual practice. All subjects will be evaluated for 
the appearance of any delayed complications within 48 hours of the end of 
the procedure. Relevant data will be collected from the patient, 
anesthesiologist, EPIC, and Compurecord. 
All medications administered and procedures performed are identical to 
those performed if not enrolled in the study, with the only exception being 
the video laryngoscopy.  
 
 
 
Data to be collected: 
Age 
Gender 
Body Mass Index (BMI) 
Mallampati score 
Head and neck pathology: 
a) Location of mass, if present 
b) History of surgical procedure 
c) History of radiation 
Visual Analog Score (VAS) of ease of bronchoscopic intubation by 
anesthesiologist 
C-MAC Video Laryngoscope Cormack-Lehane View (grade 1-4) 
GlideScope AVL Video Laryngoscope Cormack-Lehane View (grade 1-4) 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
8 
Revised  9/2/14 
Occurrence of any complications 
 
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
All researchers who will access the data have completed the institutional HIPAA 
certification. Extracted data will be de-identified before being given to the 
statistician for analysis. Any intermediary data files containing extracted PHI will 
be stored on secured hospital servers and destroyed after data analysis is 
complete. All study data at Mount Sinai stored electronically will follow MSMC 
policies. All PHI that is not stored on a limited access Mount Sinai IT maintained 
network drive will be encrypted and password protected. Statistical analysis will 
be carried out by a statistician employed by the Department of Anesthesiology. 
When the de-identified data set are released for analysis, a one-way hash ID will 
be generated for each record.  Only Mount Sinai study investigators with access to 
the full data set will be able to match the hash ID to the original source 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
MSSM Principal Monitor (PI): 
Last Name: Hyman 
First Name: Jaime 
Academic Title: Assistant Professor 
Department: Anesthesiology, Perioperative, and Pain Medicine 
Mailing Address: One Gustave L. Levy Place, Box 1010, New York, NY 10029 
Phone: 212-241-7473 
E-mail: Jaime.hyman@mountsinai.org  
 
MSSM Additional Monitor (Co-investigator): 
Last Name: Demaria 
First Name: Samuel 
Academic Title: Associate Professor 
Department: Anesthesiology, Perioperative, and Pain Medicine 
Mailing Address: One Gustave L. Levy Place, Box 1010, New York, NY 10029 
Phone: 212-241-7473 
E-mail: Samuel.demariajr@mountsinai.org 
  
 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
9 
Revised  9/2/14 
Dr. Hyman and Dr. Demaria are board certified anesthesiologists with expertise in 
difficult airway management. All subjects will be monitored closely in the 
immediate perioperative period by the anesthesia team caring for the patient. 
Participants will also be seen postoperatively within 48 hours to assess for 
delayed complications, or called by telephone in the case of ambulatory 
procedures. Ambulatory participants will also receive instructions and a business 
card in order to have a point of contact to report a potential adverse event at any 
time during or after participation. They will also be specifically informed that 
they should receive emergency department care for any signs or symptoms of 
airway compromise. Any serious adverse event will be recorded by the research 
team in a non-anonymized fashion and reported directly to the Mount Sinai 
Institutional Review Board. 
j) Withdrawal of Subjects 
Subjects will be immediately withdrawn from the study if:  
• Any difficulty resulting in airway injury occurs during the initial 
awake bronchoscopic intubation 
• The awake bronchoscopic intubation is not able to be performed 
successfully 
If withdrawn from the study, the anesthesiologist will not perform the 
planned laryngoscopy with the video laryngoscope.  
 
5) 
Risks to Subjects 
It is reasonably foreseeable that participants will have an increased risk of 
sore throat from the addition of video laryngoscopy.  
Video laryngoscopy has the potential cause damage to oropharyngeal 
structures, including but not limited to: dentition, hard palate, soft palate, 
epiglottis, vocal cords, larynx, and soft tissue. These injuries are more 
likely to occur when struggling to obtain an adequate view of the larynx in 
order to intubate, which will not be the case for this study. Since the 
airway will be protected with an endotracheal tube during laryngoscopy, 
damage/ bleeding in the airway should not lead to issues with oxygenation 
or ventilation.  
There is a risk of hemodynamic changes during laryngoscopy. The 
anesthesiologist will have the ability to treat tachycardia, bradycardia, 
hypertension, and hypotension with the appropriate pharmacologic agents.  

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
10 
Revised  9/2/14 
There is a slight risk of unintentional extubation during laryngoscopy- if 
this is to happen the anesthesiologist should be able to reintubate the 
patient using either the flexible bronchoscope or video laryngoscope, but it 
is possible that reintubation would be difficult. 
There is a slight risk of having to keep the patient intubated 
postoperatively due to continued bleeding or swelling from damage during 
video laryngoscopy. If this is to occur, the patient will be admitted to an 
acute care setting for further ventilation management and eventual 
extubation.  
6) 
Provisions for Research Related Injury 
Subjects will be monitored during surgery and during recovery from 
anesthesia. Upon discharge, subjects will be provided with a phone 
number to call should they have any concerns related to surgery, 
anesthesia, or the study. If necessary, subjects will be instructed to return 
to the hospital should any complication requiring medical attention occur, 
or to the nearest emergency department for any signs of airway 
compromise. 
Subjects who are injured as a result of this study will be treated until the 
resolution of the adverse event and the cost billed to them and/or their 
insurance carrier. Patients will not be compensated for research related 
injury, with the exception of damage to dentition that occurs during the 
course of anesthetic care, which is routinely covered by the department of 
anesthesiology. 
Anesthesiologists and intensive care unit staff will be available to maintain 
ventilation and airway management in the event of airway damage/ 
bleeding requiring prolonged intubation. ENT surgeons will be present in 
the operating room and immediately available in the unlikely case of need 
for an emergent surgical airway. ENT surgeons would also be available 
for evaluation and treatment of non-emergent oropharyngeal injuries.  
7) 
Potential Benefits to Subjects 
Participation in this study will not lead to any direct benefit to the patient.  
8) 
Provisions to Protect the Privacy Interests of Subjects 
The de-identified data will be stored on secure, password-protected servers 
maintained by Mount Sinai Information Technology (IT).  Access to the 
data will only be available to Mount Sinai IT administrators, the primary 
investigator, and co-investigators.  When the de-identified data set are 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
11 
Revised  9/2/14 
released for analysis, a one-way hash ID will be generated for each record.  
Only study investigators with access to the full data set will be able to 
match the hash ID to the original record.  All investigators have completed 
HIPAA training regarding maintaining patient PHI confidentiality. 
During the preoperative evaluation, subjects will be asked what number 
they prefer to be contacted at after discharge. They will also be asked 
whether it is ok for an investigator to leave a message. All messages will 
be of a general nature and will not contain personal health information. 
Moreover, post-operative evaluation by phone within the 48 hours 
following surgery is routine practice. 
9) 
Economic Impact on Subjects 
There are no costs to subjects for participating in this study. There will be 
no additional visits or tests related to study participation 
10) 
Payment to Subjects 
There is no payment to subjects 
11) 
Consent Process  
Eligible patients will be invited to participate in the study by an 
investigator after the preoperative evaluation in the preoperative holding 
area on Annenberg 7 on the day of surgery. A study investigator will 
describe the study in detail, answer questions, confirm understanding, and 
provide the consent form for review. The patient will be given privacy to 
review the consent form in detail and will then have another opportunity to 
ask questions prior to signing consent. The voluntary nature of this study 
will be emphasized, and patients who initially agreed to participate may 
choose to decline participation any time prior to anesthetic induction. 
Participants will be asked about the study to confirm understanding prior 
to providing written informed consent. Non-English speaking subjects will 
not be eligible for this study. SOP HRP-090 will be followed. 
 
12) 
Process to Document Consent in Writing 
Consent will be documented using the standard PPHS consent template  
13) 
Vulnerable Populations 
No vulnerable populations will be included in this study 
14) 
Multi-Site Human Research (Coordinating Center) 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
12 
Revised  9/2/14 
N/A 
15) 
Community-Based Participatory Research 
N/A 
16) 
Sharing of Results with Subjects 
If the patient desires, the anesthesiologist will discuss any notable results 
from the laryngoscopy with the patient during the postoperative visit or 
phone call and all questions will be answered. Video laryngoscopic view 
will also be recorded in the patient’s electronic anesthesia record. 
17) 
External IRB Review History 
This is a new IRB application 
 
18) 
Control of Drugs, Biologics, or Devices 
We will not use any new or different devices for this study. The flexible 
bronchoscope and the video laryngoscopes will be available through the Mount 
Sinai Anesthesiology department. All devices will be stored in the “anesthesia 
work room” located in close proximity to the operating rooms. The 
anesthesiology department will provide the personnel and resources to keep 
equipment clean and in good condition.  
 
 
References: 
 
1. 
Apfelbaum JL, Hagberg CA, Caplan RA, et al. 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;118:251-70. 
2. 
Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia 
2016;71:12-6. 
3. 
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;70:400-6. 
4. 
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;116:1210-6. 

 
Protocol Title: 
Evaluation of Video Laryngoscopy in Patients with Head 
and Neck Pathology 
Principal Investigator 
Name/Contact Info:  
Jaime Hyman, MD 
Jaime.hyman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Jacqueline Crittendon 
jacqueline.crittendon@mountsin 
Date Revised: 
3/13/2018 
Study Number: 
 GCO#17-0963/IF2253490 
 
13 
Revised  9/2/14 
5. 
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;114:34-41. 
6. 
Cook TM, Woodall N, Frerk C, Fourth National Audit P. 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. British 
journal of anaesthesia 2011;106:617-31. 
7. 
Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to 
determine the future. Anesthesiology 2012;116:1181-2. 
8. 
Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in 
obstetric patients: a survey of anaesthetists in the Oxford region. International journal of 
obstetric anesthesia 2000;9:78-82.