Clinical Trial of PneumaGlide: A Novel Airway Device to Aid Endotracheal Intubations for Novice Intubators
Phase: NA
Conditions: Intubation Complication, Intubation;Difficult
Sponsor: University at Buffalo

Cover Page for the protocol 
Official Title: 
Novel Airway Device to Aid Endotracheal Intubations 
NCT number: 
NCT03340207 
Document Type: 
Study Protocol including Statistical Analysis Plan 
incorporated in the protocol and Informed Consent 
Date of the 
Document: 
April 15 2019 for the study protocol; The latest version of 
the informed consent template was April 02, 2015 

1. Introduction/Objective 
The proposed study will examine the efficacy of Pneumoglide on facilitating the process of endotracheal 
intubation while it prevents injury to the upper teeth and aspiration of gastric contents into the lungs. 
These two complications are among common mishaps during endotracheal intubation by less 
experienced operators.  
2. Subjects/Methods/Data Collection 
This study will be a prospective clinical trial of patients who will receive general anesthesia with 
endotracheal intubation for their surgery. All patients undergoing general anesthesia and assigned to be 
anesthetized by an anesthesia team that includes a PGY-2 or PGY-3 residents will be screened for 
enrollment. All patients with recognized as difficult intubation or with obvious anatomical deviation of 
their airway (congenital or cancer-related) will be excluded. After initial screening and signing an 
informed consent, patients will be randomized into two groups: Group I will be intubated with while 
Pneumoglide device is used and Group II will be intubated in a conventional method without using 
Pneumoglide device. The primary endpoint of the study will be the success of the intubation by the 
trainees, The secondary outcome variables will include the number of the attempts to intubate the 
trachea, the time it lapse from the reaching to the laryngoscope device until the time the trachea is 
intubated and the correct placement of the endotracheal tube is verified.  Additionally, we will collect all 
cases the required assistance from the attending staff in either group. Among patients in group I, the 
grade of vocal cord visualization will be documented with direct laryngoscopy with Macintosh blade 3-4 
before inserting Pneumoglide and after insertion of the device. In group II, this variable will not be 
collected.  Collected data will soon be entered into an Excel worksheet and will be saved in an approved 
Share Point folder allocated to this project. A copy of the informed consent and HIPPA waiver will also 
be saved in this folder. Access to this folder is granted for the authorized personnel and for the Ethics 
officer for auditing purposes. 
3. Data Analysis 
There is currently no available data with the use of this device, therefore, we were unable to do a power 
analysis for sample size determination. This study is therefore considered a pilot project and the results 
obtained form this study can be used for sample size determination in future clinical trials.  
Data will be analyzed quantitatively using VA approved programs, located at Dr. N. Nader’s office. 
Following removal of patients’ identifiable information except for age and the date of procedure, the 
data will be transferred to an SPSS worksheet that is installed on a MacBook Pro located at Dr. Nader’s 
Office (204C) for further statistical analysis. The output files of the analyses will then reloaded to the 
Share Point folder and will remain there for future access by the authorized study team members.  
4. Risks 
This project will only offer minimal risk to patients directly related to the use of Pneumoglide device This 
devices is classified as Class I by FDA which only granted for devices that has minimal risk to patients, 
and therefore was exempted from obtaining IND number from FDA. The only risk is from possible 
injuries to lip, teeth and oral mucosa from rough handling of the airway which basically same to patients 
from either group.  Additionally, there may be some difficulty in intubating trachea by novice trainees. 
All these procedures are performed in the presence and direct supervision by an attending 

anesthesiologist with expertise in placing endotracheal tubes.  Patient safety is the highest priority and 
all attending are trained to intervene timely and decrease any potential mishap from occurring.  
5. Benefits 
This study will benefit both future patients of the VA as follow: 
a. Facilitating intubation by improving visualization of the airway (glottis) 
b. Decrease the risk of injury to the teeth, lips and oral mucosa by adding another protective layer 
c. Decrease the risk of gastric aspiration by occluding the esophageal opening while placing the 
endotracheal tube.  
Data Collection tool (Excel Worksheet) 
Name 
Date 
Group Age MP 
preLG 
PostLG Success #Att 
TTI 
FHelp EsoInt Inj 
GasAsp 
Case1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Variable information:  
Name:   
(Name+Last4) 
Date:   
mm-dd-yy 
Group:  
Device group 
Age: 
 
years 
MP: 
 
Mallampathi Classification of the airway 
PreLG:   
Laryngeal grade before insertion of Pneumoglide 
PostLG:  
Laryngeal grade after insertion of Pneumoglide 
Success: 
Successful intubation by the trainee 
#Att: 
 
Number of the attempts to successfully intubate 
TTI: 
 
Time to intubate (minutes) 
FHelp:  
Help from the faculty staff 
Esoint:  
Inadvertent esophageal intubation 
Inj:  
 
Injury to the lips, teeth and oral mucosa 
GasAsp:  
Gastric Aspiration 
 
 
 

Research Informed Consent Document 
 
Department of Veterans Affairs 
 
 
VA Western New York Healthcare System, Buffalo, New York 
PARTICIPANT NAME: 
 
DATE: 
 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader, MD PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
                                                                                                                                                 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
         Page 1 of 8 
VAWNYHS IRB Version 4/2/15 
 
BLACK FONT: 
The black font throughout the template is required language.   
RED FONT: 
The red font requires you to input language specific to your study, or 
provides instructions for the section. 
BLUE FONT: 
The blue font throughout the template is optional, and only required if 
necessary for your study. 
 
Informed Consent to Participate in Research 
Sponsor: UB Center for Advanced Biomedical and Bioengineering Technology (UB CAT) 
The investigators have been approved to complete this study by the Facility Financial Conflict of 
Interest Administrator. 
We are asking you to volunteer for a research study at the VA Western New 
York Healthcare System [VAWNYHS].   
The purpose of this study is to examine the feasibility of using Pneumoglide as an aid to place the 
endotracheal tube by the novice trainees in a supervised clinical setting.  
Should you take part in this study? 
 
This form tells you about this research study.  This form explains: 
• Why this study is being done. 
• What will happen during this study and what you will need to do? 
• Whether there is any chance you might experience potential benefits from being in the study. 
• The risks of having problems because you are in this study. 
Before you decide: 
• Read this form. 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 2 of 8 
VAWNYHS IRB Version 4/2/15 
• Have a friend or family member read it. 
• Talk about this study with the person in charge of the study or the person explaining the study.  
You can have someone with you when you talk about the study. 
• Talk it over with someone you trust. 
• You may have questions this form does not answer.  You do not have to guess at things you don’t 
understand.  If you have questions ask the person in charge of the study or study staff as you go 
along.  Ask them to explain things in a way you can understand. 
• Take your time to think about it.  
 
It is up to you.  If you choose to take part in this study, you will need to sign this consent 
form.  If you do not want to take part in this study, you should not sign the form.   
Are you in any other research studies?             _____Yes     _____No 
Why is this research being done?  
We are asking you to participate in this study because you are scheduled to undergo a procedure that 
requires general anesthesia. General anesthesia refers to state of sleep during which you will not have 
any recollection of events, perception of pain or movement during the course of surgery/procedure. 
Because of induced paralysis of muscles, it is critical to maintain respiration through artificial 
breathing.  Placement of tube into the windpipe is a necessary step for maintaining mechanical 
ventilation. Under direct supervision of the anesthesiologists, the trainees place endotracheal tube 
with video assisted visualization of the windpipe. This device (Pneumoglide) is designed to improve the 
visualization of the windpipe. The quality of view and the time it takes from the start until successful 
placement of the tube into the windpipe will be measured and recorded for comparison.  
How long will you be in the study? 
You will be in the study for duration of general anesthesia in the operating room and make no further 
follow up visits. However, you will be asked to complete a short survey about the possible presence of 
sore throat or any breathing issues within 72 hours of discharge from the hospital. 
What will be done if you agree to be in this study? 
You will be asked about your willingness to participate in this project on the day that you are being 
evaluated for your fitness for anesthesia. If you agree to be in this study, you will be randomly assigned 
to either a group in whom this device will be used for placement of a tube into your windpipe or 
placement of the tube will take place without utilizing the study device. The study device is a conical 
device that is designed to obstruct the opening of all orifices in your mouth other than the windpipe. 
That is why it is proposed that this device may decrease the likelihood of food spillage into your lungs. 
Additionally, this device is proposed to bring the opening of the windpipe to the front and facilitate 
placement of the tube into your windpipe. The quality of visualization is graded (as per the published 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 3 of 8 
VAWNYHS IRB Version 4/2/15 
standards) before placement and after placement of the device and recorded. A member of the study 
team will time the process of tube placement from the time of inserting video scope into your mouth 
until the time that the breathing tube is successfully placed into the windpipe. This information will be 
compared to those patients in whom no such a device is placed (controls). You will have a 50% chance 
to be assigned to the device group or the control group. This random assignment is like flipping a coin; 
you will have a one in two chance of being assigned to either group.  
How many other people will be in this study? 
About 200 people will be in this study at this location. People will also participate at other study 
sites. A total of about 400 people will be included all together.  
What are the possible risks? 
This device is made out of soft rubber material and therefore the risk of injuring the mucosa of your 
mouth, teeth, crowns or dentures is minimal. During certain stages of anesthesia, especially during 
emergence when the muscle paralysis is reversed, some patient will develop some degree of clenching 
the teeth that may cut through this device. If this occurs, the remaining of the device will be carefully 
removed from the mouth before removing the tube from your windpipe.  
What are the possible benefits to you or to others if you are in this study? 
You may or may not be helped by being in this study.  However, by participating in the study, you 
may help us learn how to benefit patients in the future. 
Will it cost me anything to be in this study? 
None of the participants will pay for the cost of this airway device because they are only for research 
study purposes. You would receive the following general anesthesia with placement of tube into your 
windpipe even if you were not in the study because they are part of the standard care for your 
condition. 
Will you be paid for taking part in this study? 
You will be compensated for participation in this study project for the amount of  $10.00, which will be 
paid upon the receipt of your close out survey (consisting of 2 questions). This short survey the will be 
handed to you upon discharge from the hospital along with self-addressed and paid postage envelopes. 
An Internal Revenue Service (IRS) Form 1099 may be generated, which will use your Social Security 
Number.   
 
Does pregnancy prevent me from participating in this study? 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 4 of 8 
VAWNYHS IRB Version 4/2/15 
Since during pregnancy the tone of the throat muscles and the volume of the stomach contents are increased, 
pregnant women are at increased risk of food spillage into the lungs and therefore you should not participate 
in this study if you are pregnant.  You must inform the study staff right away if you or your partner becomes 
pregnant. 
What happens if you decide NOT to take part in this study? 
You should only be in this study if you want to volunteer.  You do not need to be in the study to 
please the study doctor or the research staff. 
If you decide NOT to take part: 
• You will not be in trouble or lose any rights you normally have.  
• You will still have the same services you would normally have. 
• You can still get your regular medical care from your regular health care practitioner. 
 
You will still receive general anesthesia for your procedure and the trainees in Anesthesiology under 
direct supervision by a licensed Anesthesiologist will place a tube into your windpipe using standard 
methods. 
What if you join the study and decide you want to stop later on? 
You can decide after signing this informed consent document that you no longer want to be in this 
study.  We will tell you about any new developments, which might affect your willingness to 
continue to participate in the study. However, you can decide you want to stop taking part in the 
study for any reason, at any time.  If you decide you want to stop being in the study, tell the study 
staff as soon as you can. 
• We will tell you how to stop safely.  We will tell you if there are any dangers if you stop 
suddenly. 
• If you decide to stop, you can continue getting care from your regular health care 
practitioner.   
Are there reasons we might take you out of the study later on? 
Even if you want to stay in the study, there may be reasons we will need to take you out of it.  
You may be taken out of this study if: 
• We find out it is not safe for you to stay in the study.  For example, your health may worsen. 
• You are not coming for your study visits when scheduled or completing study tasks as 
needed. 
• The funding for the study is stopped. 
 
What if you are injured while you are on the study? 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 5 of 8 
VAWNYHS IRB Version 4/2/15 
The VA Western New York Healthcare System will provide necessary medical treatment to you if 
you are injured by being in a research study.  This does not apply to treatment for injuries that 
occur because you did not follow study procedures.  Except in limited circumstances, the necessary 
care will be provided in VA medical facilities.  Any expenses not covered by your insurance may be 
covered by the VA, consistent with applicable law, regulation, and policy.   
Privacy and Confidentiality                                            
Any information obtained about you in this study will be treated as confidential and will be stored 
as stated in the Privacy Act of 1974.  In order to follow federal regulations, records identifying you 
may be inspected by sponsors of this study and others including, but not limited to: 
 
The VAWNYHS Medical Center Research and Development Committee and its 
Subcommittees 
 
VAWNYHS Research Staff and Research Compliance Officer 
 
The Office for Human Research Protections (OHRP) 
 
VA Office of Research Oversight (ORO) 
 
Office of the Inspector General (OIG) 
 
How will your information be used?   
The ways your study doctor will use your study-related health information and the people 
who may receive it are identified in a separate form entitled, “Department of Veterans 
Affairs HIPAA Authorization for Release of Protected Health Information for Research 
Purposes”.  You will be asked to sign that form to show that you give permission for these 
uses and sharing of your information.  You do not have to sign the authorization form.  
However, if you do not sign, you will not be able to participate in the study. 
How will your information be stored?   
All relevant clinical information will be collect on paper and transferred to an Excel-based 
datasheet, which will be stored in a password protected SharePoint folder. This folder will 
only be accessed by authorized study team members.  
How will your information be sent to the sponsor?  
Clinical source documents will not be transmitted to the sponsor. Only data after they are 
analyzed and tabulated will be transmitted to the sponsor and will certainly not include any 
identifiable information.  
How will your information be kept or destroyed?  
Your research records will be retained in accordance with the Veterans Health Administration 
(VHA) Records Control Schedule. 
 
How will your information be described to others? 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 6 of 8 
VAWNYHS IRB Version 4/2/15 
We may publish what we learn from this study.  If we do, we will not let anyone know your 
name.  We will not publish anything else that would let people know who you are.  
This device is classified as Class I and therefore it was exempted from obtaining a FDA-IND 
number.  
How do you withdraw permission to use your information?  
You can revoke this form at any time.  This means you can tell the research team to stop using and 
sharing your information.  If you revoke this form: 
• You will no longer be a participant in this research study. 
• We will stop collecting information about you.  
• The information that we have collected before you tell us to stop may already have 
been used or shared, or we may need it to complete the research, so you cannot 
withdraw that information. 
• Staff may follow-up with you if there is a medical reason to do so. 
To revoke this form, you must tell us in writing.  To revoke your authorization, you must write to 
the Release of Information Office at this facility, or you can ask a member of the research team to 
give you a form to revoke the authorization. Your request will be valid when the Release of 
Information Office receives it. If you revoke this authorization, you will not be able to continue to 
participate in the study. 
If you revoke this authorization, your research doctor or staff can continue to use information about 
you that was collected before receipt of the revocation. The research team will not collect 
information about you after you revoke the authorization. 
Your Rights: 
You can refuse to sign this form.  If you do not sign this form: 
• You will not be able to be in this research.  However, you can receive other procedures that 
are currently available for your condition as part of your regular medical treatment. 
• This will not change your health care outside of this study. 
• This will not change your health care benefits. 
• This will not change the costs of your health care. 
There will be no costs to you for any treatment or testing done as part of this study. 
Eligibility for medical care is based on the usual VA eligibility policy.  It is not guaranteed by being 
in a study.  If you get medical care by the VA that is not part of the study, you may be charged co-pay 
for that medical care based on your VA eligibility. 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 7 of 8 
VAWNYHS IRB Version 4/2/15 
You can get answers to your questions, concerns, complaints or issues about this 
study. 
NADER D. NADER, MD, or his designee, has explained the study to you and answered all of your 
questions.  If you have questions, concerns or complaints about the research, you have been told 
you can call Dr. Nader at 716-341-2715 during the day and Dr. Nader at 716-341-2715 after hours.  
You have been told of the risks or discomforts and possible benefits of the study.  You have been 
told of other choices of treatment available to you.  If you have questions about your rights as a 
research participant, or if you think you have a research-related injury, you may contact the Chair of 
the Research & Development Committee at (716) 862-6528 or the Patient Advocate at (716) 862-
8752.  You may also contact the Research Compliance Officer at (716) 862-3218 if you have 
concerns, questions, or complaints and cannot reach the research team, or if you wish to talk to 
someone else. 
You have been told that if you receive care from non-VA providers, you should tell your other 
healthcare providers about your participation in this study.  If your provider knows of information 
that may be useful to this study, you will tell them to contact the Principal Investigator (PI). 

IRBNet#: 1092558 ,FK: 8.8 
Research Informed Consent Document 
Department of Veterans Affairs 
VA Western New York Healthcare System, Buffalo, New York 
PRINCIPAL INVESTIGATOR: 
Nader D. Nader MD, PhD 
TITLE OF RESEARCH STUDY: Clinical Trial of PneumaGlide: A Novel Airway Device to Aid 
Endotracheal Intubations for Novice Intubators 
 
 
Version Date:  3/1/2016 
 
 
 
 
 
 
 
     Page 8 of 8 
VAWNYHS IRB Version 4/2/15 
Statement of Participation in Research:  
You have read or have had read to you all of the above.  It is up to you to decide whether you want 
to take part in this study.  If you want to take part, please read the statements below and sign the 
form if the statements are true. 
I freely give my consent to take part in this study and authorize that my health information, 
as agreed above, be collected and disclosed in this study.  I understand that by signing this 
form I am agreeing to take part in research.  I have received a copy of this form to take with 
me. 
I understand that I do not have to be in this study.  My refusal to take part will involve no 
penalty or loss of rights to which I am entitled.  I may leave this study whenever I wish 
without penalty or loss of VA or other benefits to which I am entitled. 
 
 
______________________________________________      
Participant's Signature           
 
 
______________________________________________  
 
 
 
 
_______________ 
Printed Name of Participant  
 
   
               
 
 
Date 
 
 
 
 
_______________________________________________                
 
 
 
 
 
 
Signature of Individual Obtaining Participant’s Consent     
 
     
Date  
 
 
__________________________________________________ 
 
Printed Name of Individual Obtaining Participant’s Consent 
 
 
____________________________________________________         ____ __________________  
________________ 
Surrogate/Legal Representative Signature               (Print Name)  
             Date 
 
 
 
________________________________________ 
Relationship to Participant