Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
Phase: NA
Conditions: Pulmonary Ventilation
Sponsor: University of New Mexico

 
 
NCT 04274686 
 
Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient 
 
 
 
Study Protocol 
Document Date: February 11, 2020 
 
Approved by the  
Human Research Review Committee  
at the University of New Mexico Health Sciences Center  
on: February 12, 2020 
 
Note: “Version Date” of 7/7/2019 in the document footer refers to the  
protocol template form only, and not its contents 
 
 

Tegaderm™ Placement for Bag Mask Ventilation in the Bearded Patient  
 
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PROTOCOL TITLE: 
Tegaderm™ Placement for Bag Mask Ventilation in the Bearded Patient  
PRINCIPAL INVESTIGATOR: 
Neal Gerstein, MD 
Anesthesiology & Critical Care Medicine 
272-2610 
ngerstein@salud.unm.edu 
ADMINISTRATIVE CONTACT: 
 
Tim Petersen, PhD 
 
Anesthesiology & Critical Care Medicine 
 
272-1762 
 
timpetersen@salud.unm.edu 
VERSION NUMBER: 
3 
DATE: 
February 11, 2020 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
DOD (Department of Defense) 
 
DOE (Department of Energy) 
 
DOJ (Department of Justice) 
 
ED (Department of Education) 
 
EPA (Environmental Protection Agency) 
 
FDA (Food and Drug Administration) 
 
HHS (Department of Health and Human Services) 
 
VA 
 
Other:       
 
FUNDING:  Departmental sources only 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No 
NIH Definition of a Clinical Trial:  
A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 
subject’s environment for the purpose of modifying one or more health-related biomedical 
or 
behavioral 
processes 
and/or 
endpoints. 
Examples 
include: 
drugs/small 

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molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes.  
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:        
1) 
Does the study involve human participants? 
 Yes   
 No 
2) 
Are the participants prospectively assigned to an intervention? 
 Yes   
 No 
3) 
Is the study designed to evaluate the effect of the intervention on the participants? 
 Yes   
 No  
4) 
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
 Yes   
 No 
 
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if…  
• You are studying healthy participants 
• Your study does not have a comparison group (e.g., placebo or control) 
• Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug 
• Your study is utilizing a behavioral intervention 
 
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    
 Yes   
 No  
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu  
 
Table of Contents 
1. 
Objectives .................................................................................................................... 4 
3. 
Study Design................................................................................................................ 8 
4. 
Inclusion and Exclusion Criteria ................................................................................. 8 
5. 
Number of Subjects ..................................................................................................... 9 
6. 
Study Timelines ......................................................................................................... 10 
7. 
Study Endpoints ......................................................................................................... 10 
8. 
Research Setting ........................................................................................................ 10 
9. 
Resources Available .................................................................................................. 11 

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10. 
Prior Approvals ...................................................................................................... 11 
11. 
Multi-Site Research ............................................................................................... 11 
12. 
Study Procedures ................................................................................................... 11 
13. 
Data Analysis ......................................................................................................... 14 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 15 
15. 
Withdrawal of Subjects .......................................................................................... 16 
16. 
Data Management/Confidentiality ......................................................................... 16 
17. 
Data and Specimen Banking .................................................................................. 17 
18. 
Risks to Subjects .................................................................................................... 17 
19. 
Potential Benefits to Subjects ................................................................................ 17 
20. 
Recruitment Methods ............................................................................................. 17 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 18 
22. 
Economic Burden to Subjects ................................................................................ 18 
23. 
Compensation ........................................................................................................ 19 
24. 
Compensation for Research-Related Injury ........................................................... 19 
25. 
Consent Process ..................................................................................................... 19 
26. 
Documentation of Consent .................................................................................... 20 
27. 
Study Test Results/Incidental Findings ................................................................. 20 
28. 
Sharing Study Progress or Results with Subjects .................................................. 20 
29. 
Inclusion of Vulnerable Populations ...................................................................... 20 
30. 
Community-Based Participatory Research ............................................................ 21 
31. 
Research Involving American Indian/Native Populations ..................................... 21 
32. 
Transnational Research .......................................................................................... 21 
33. 
Drugs or Devices.................................................................................................... 21 
34. 
Principal Investigator’s Assurance ........................................................................ 21 
Checklist Section .............................................................................................................. 22 
34. Export Control…………………………………………………………………….22 

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1. Objectives 
1.1. This is a prospective randomized cross-over controlled trial intended to 
assess the efficacy of applying Tegaderm™ over bearded patients’ 
circumoral area to improve bag mask ventilation after induction of general 
anesthesia. We will use Pneumotachography to measure our primary 
outcome: the amount of airway leak during mask ventilation (Tidal 
Volume Inspired mL –Tidal Volume Expired mL). Secondary measures 
include peak inspiratory pressures (PPins; cm H2O) and airway resistance 
(Res; cm H2O/l/sec). 
1.2. Hypothesis: Application of Tegaderm™ over patient with circumoral facial hair 
will significantly improve bag mask ventilation via improvement of facemask seal. 
2. Background 
2.1. Bag mask ventilation (BMV) is an essential skill for health care professionals 
involved in airway management.  This ubiquitously needed skill can be lifesaving 
in emergent situations but is frequently impeded by various patient characteristics.  
If incorrectly approached and applied, BMV may be ineffective and lead to 
hypoxia, hypercarbia 1 or pulmonary aspiration 2. Difficult mask ventilation 
(DMV) pathophysiology is well described by El-Orbany et al as having two broad 
components: 1) operator or technique related and 2) airway related factors.  
Independent risk factors for DMV include the presence of a beard, increased BMI 
(> 26 kg/m2), edentulism, age >55 years, history of snoring, Mallampati III or IV, 
male gender, limited mandibular protrusion, and airway masses 1,3–5. In recent 
years, there has been a joint effort amongst emergency physicians, 
anesthesiologists, and pre-hospital clinicians to improve our understanding of 
BMV, standardize our approach and teach optimization with a surplus of corrective 
measures when faced with difficult BMV 6–11. The most basic optimizing 
maneuvers such as switching from a single hand to two-handed thenar-eminence 
grip has shown promising objective results 12,13. More novel approaches to improve 
facemask seal have been suggested such as keeping dentures in mouth or packing 
the mouth with gauze during induction of general anesthesia of the edentulous 
patient 14, and employing ergonomically designed facemasks 15, accessories 16, and 
intraoral masks 17,18 to reduce operator error and grip fatigue.  
A common independent DMV risk factor encountered by multiple modalities of 
healthcare providers is the bearded airway.  Bag mask ventilation in the bearded 
patient has many difficulties to overcome, for both the novice and expert alike. In 
a review of 50,000 anesthetics looking at prediction of impossible mask 
ventilation, the bearded patient was deemed the only modifiable independent 
predictor despite attempts by multiple anesthesiologists 19. There are multiple 
factors that contribute to beards as an independent risk factor for DMV.  The 
presence of a beard decreases the ability to create an airtight seal of the face mask 
increasing air leakage during positive pressure ventilation by providers 19,20. 
Beards can also conceal architectural facial anomalies concealing other risk factors 
for DMV, such as men with retrolithic jaws in attempt to alter their appearance 21. 

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Additionally, beards can inhibit the provider’s ability to effectively grip the jaw to 
perform an adequate chin lift 22.  
2.2. There have been multiple proposed techniques to address the management of 
beards.  The most effective, but perhaps hardest to achieve, is shaving of the beard 
prior to induction 3.  For a willing patient in a non-emergent setting this may be 
the most ideal intervention, but has limited compliance, and is not applicable in 
emergent or pre-hospital settings where time is more crucial and resources more 
limited. Viscous jelly to form an adequate seal at the mask-beard-skin interface 
has been proposed 23, but may further limit effective grip to perform chin lift. Use 
of a pediatric mask over the nose and nasopharyngeal airway with manual closure 
of the oral airway 24, which has shown promising data in maintaining upper airway 
patency but may not be readily translatable across multiple provider modalities.  
The use of cling film to wrap the face in an emergent scenario 25, previously noted 
to require significant head manipulation, potential risk for pulmonary edema, and 
limiting gas exchange during the intervention 26. The use of a supraglottic airway 
device may also be an appropriate intervention for DMV bearded patients, but 
there is limited evidence in the literature to say LMA is superior to face masks in 
the setting of difficult airways and a supraglottic airway is commonly an 
inappropriate airway device in the perioperative period 6,27–29. 
 
2.3. A simple novel approach noted improvement of BMV in the bearded patient 30,31 
by placing a large (6 x 8 inch) TegadermTM across the lower face to improve face-
to-mask seal, after first cutting a hole in the device to permit passage of air and 
instruments. To date, evidence for improved facemask seal in the bearded patient 
has only been anecdotal.  We plan on studying a heretofore non-studied technique 
involving application of a large TegadermTM across the lower face of the bearded 
patient to quantify its effectiveness at improving mask ventilation in this 
anesthetized population. This technique can be applied rapidly, without dramatic 
head manipulation, preserving effective grip, and can be adopted across multiple 
healthcare modalities, making it a worthy intervention to explore in detail. By 
quantifying the effectiveness of this intervention, we hope this study can be used 
to inform guidelines for the management of difficult BMV in the bearded patient. 
 
References 
1.  
El-Orbany M, Woehlck HJ. Difficult mask ventilation. Anesth Analg. 
2009;109(6):1870-1880. doi:10.1213/ANE.0b013e3181b5881c 
2.  
von Goedecke A, Wenzel V, Hörmann C, et al. Effects of face mask ventilation in 
apneic patients with a resuscitation ventilator in comparison with a bag-valve-mask. 
J Emerg Med. 2006;30(1):63-67. doi:10.1016/j.jemermed.2005.02.021 

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3.  
Langeron O, Masso E, Huraux C, et al. Prediction of difficult mask ventilation. 
Anesthesiology. 2000;92(5):1229-1236. 
4.  
Yildiz TS, Solak M, Toker K. The incidence and risk factors of difficult mask 
ventilation. J Anesth. 2005;19(1):7-11. doi:10.1007/s00540-004-0275-z 
5.  
Kheterpal S, Han R, Tremper KK, et al. Incidence and predictors of difficult and 
impossible mask ventilation. Anesthesiology. 2006;105(5):885-891. 
6.  
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(2):251-270. doi:10.1097/ALN.0b013e31827773b2 
7.  
Salem MR, Ovassapian A. Difficult Mask Ventilation: What Needs Improvement?: 
Anesth Analg. 2009;109(6):1720-1722. doi:10.1213/ANE.0b013e3181be0541 
8.  
Matioc A, Galgon R, Joffe A. Efficacy of one-handed ventilation techniques. 
Anaesthesia. 2014;69(7):794-795. doi:10.1111/anae.12769 
9.  
Otten D, Liao MM, Wolken R, et al. Comparison of Bag-Valve-Mask Hand-Sealing 
Techniques in a Simulated Model. Ann Emerg Med. 2014;63(1):6-12.e3. 
doi:10.1016/j.annemergmed.2013.07.014 
10.  Braude DA, Tawil I, Gerstein NS, Carey MC, Petersen TR. Comparison of Bag-
Valve-Mask Hand-Sealing Techniques in a Simulated Model. Ann Emerg Med. 
2014;63(6):784-785. doi:10.1016/j.annemergmed.2014.01.037 
11.  Liao MM, Otten D, Byyny RL, Haukoos JS. In reply. Ann Emerg Med. 
2014;63(6):785. doi:10.1016/j.annemergmed.2014.02.019 
12.  Gerstein NS, Carey MC, Braude DA, et al. Efficacy of facemask ventilation 
techniques in novice providers. J Clin Anesth. 2013;25(3):193-197. 
doi:10.1016/j.jclinane.2012.10.009 
13.  Fei M, Blair JL, Rice MJ, et al. Comparison of effectiveness of two commonly used 
two-handed mask ventilation techniques on unconscious apnoeic obese adults. Br J 
Anaesth. 2017;118(4):618-624. doi:10.1093/bja/aex035 
14.  Golzari SE, Soleimanpour H, Mehryar H, et al. Comparison of Three Methods in 
Improving Bag Mask Ventilation. Int J Prev Med. 2014;5(4):489-493. 
15.  Bauman EB, Joffe AM, Lenz L, DeVries SA, Hetzel S, Seider SP. An evaluation of 
bag-valve-mask ventilation using an ergonomically designed facemask among 
novice users: a simulation-based pilot study. Resuscitation. 2010;81(9):1161-1165. 
doi:10.1016/j.resuscitation.2010.05.005 

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16.  Peck J, Viswanath O, Rosen G. Mask Ventilation Grip: A Life-Saving Innovation. 
Ochsner J. 2018;18(2):112-113. doi:10.31486/toj.18.0010 
17.  Amack AJ, Barber GA, Ng PC, Smith TB, April MD. Comparison of Ventilation 
With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed 
Face Mask in a Cadaver Model: A Randomized Crossover Trial. Ann Emerg Med. 
2017;69(1):12-17. doi:10.1016/j.annemergmed.2016.04.017 
18.  Kuna ST, Woodson LC, Solanki DR, Esch O, Frantz DE, Mathru M. Effect of 
Progressive Mandibular Advancement on Pharyngeal Airway Size in Anesthetized 
Adults. Anesthesiology. 2008;109(4):605-612. doi:10.1097/ALN.0b013e31818709fa 
19.  Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of 
impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 
2009;110(4):891-897. doi:10.1097/ALN.0b013e31819b5b87 
20.  Ovassapian A. Fiberoptic Endoscopy and the Difficult Airway. Lippincott-Raven 
Philadelphia; 1996. 
21.  Kryger MH. Atlas of Clinical Sleep Medicine. Elsevier Health Sciences; 2009. 
22.  Crooke J. The bearded airway. Anaesthesia. 1999;54(5):500-500. 
doi:10.1046/j.1365-2044.1999.0907n.x 
23.  Gourdin MJ, Dransart CJ, Ducombs O, Dubois PE. Improved face mask ventilation 
in the bearded patient. Eur J Anaesthesiol. 2005;22(11):894. 
doi:10.1017/S0265021505251505 
24.  Oto J, Li Q, Kimball WR, et al. Continuous positive airway pressure and ventilation 
are more effective with a nasal mask than a full face mask in unconscious subjects: 
a randomized controlled trial. Crit Care Lond Engl. 2013;17(6):R300. 
doi:10.1186/cc13169 
25.  Vincent C, Ames WA. The bearded airway. Anaesthesia. 1998;53(10):1034-1035. 
doi:10.1046/j.1365-2044.1998.0669n.x 
26.  Hancock AC. The bearded airway. Anaesthesia. 1999;54(4):408-408. 
doi:10.1046/j.1365-2044.1999.00884.x 
27.  Augoustides JG, Groff BE, Mann DG, Johansson JS. Difficult airway management 
after carotid endarterectomy: utility and limitations of the Laryngeal Mask Airway. 
J Clin Anesth. 2007;19(3):218-221. doi:10.1016/j.jclinane.2006.06.008 
28.  Fundingsland BW, Benumof JL. Difficulty using a laryngeal mask airway in a 
patient with lingual tonsil hyperplasia. Anesthesiology. 1996;84(5):1265-1266. 
29.  Kidani DCH, Shah NK. The use of a laryngeal mask airway after a prolonged 
suspension laryngoscopy to preserve a vocal cord fat graft. Anesth Analg. 

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2007;105(6):1753-1754, table of contents. 
doi:10.1213/01.ane.0000286322.04940.a5 
30.  Sinha AC, Purohit M, Singh PM, Goudra BG. Difficult mask ventilation: Tegaderm 
for sealing a patient’s fate! J Clin Anesth. 2013;25(8):679-680. 
doi:10.1016/j.jclinane.2013.07.009 
31.  McGuigan PJ. Difficult mask ventilation: preoperative Tegaderm application to 
eliminate mask leak. J Clin Anesth. 2014;26(6):508-509. 
doi:10.1016/j.jclinane.2014.01.004 
 
 
3. Study Design 
3.1. Our study design is a randomized prospective crossover trial in adult patients (>18 
years), with circumferential perioral facial hair longer than 5 mm who will undergo 
elective non-cardiac surgery in the main adult operating rooms of the University 
of New Mexico Hospital. 
3.2. Allocation concealment: Providers and subjects will be blinded to which method 
they will start with (control versus intervention) via envelope method prior to 
induction of general anesthesia. 
3.3. Subjects who are consented to participate in the study will have facial hair 
measured as a continuous variable length (mm).   
3.4. Mask ventilation operators will be confined to anesthesiology residents, 
anesthesiologist assistants (AA), and AA students all of whom are familiar with 
bag mask ventilation.  Mask ventilation will occur using a two-handed Thenar-
Eminence (TE) grip without the addition of an oropharyngeal airway.  All 
operators will be instructed on how to perform this technique prior to patient 
enrollment. We will use Pressure Control ventilation mode on Anesthesia 
Ventilator machine (Dräger Perseus A500) set at 10 breaths per minute, I:E time 
of 1:2 and peak inspiratory pressure of 20 cm H2O, all of which are routine in our 
practice and within typical ranges at the national level.  These are specified only 
in order to reduce practice variation not related to the intervention itself.  An 
external pneumotachograph device and sensors (Phillips Respironics NM3™ 
respiratory profile monitor; Respironics CAPNOSTAT® Mainstream CO2 sensor) 
will be used to measure ventilation parameters ( Vtins; mL, VtExp; mL, PPins; cm 
H2O, Res; cm H2O/L/sec) with collected data electronically saved to a dedicated 
flash drive associated with the pneumotachograph . 
 
4. Inclusion and Exclusion Criteria 
4.1. A study investigator will screen patients with facial hair on the day of surgery in 
the preoperative holding area.  We will enroll patients on the day of surgery and 
have them sign an informed written consent to participate in the study.  

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4.2. Inclusion criteria  
• 
Adult patients with perioral facial hair greater than 5 mm in length, and 
undergoing elective non-cardiac surgery inclusive of BMV.   
4.3. Exclusion criteria are listed below.  The exclusion criterion relating to known 
Tegaderm allergy will be screened for during verbal communication between the 
patient/participant and his/her doctor (who is also an investigator).  All other 
exclusion criteria draw on information that is part of the routine pre-anesthesia 
assessment conducted for patients having general anesthesia. 
• 
known allergy to Tegaderm product and/or its adhesive 
• 
emergency surgery 
• 
active or unstable cardiac disease 
• 
ASA physical status* ≥ 4. ASA 4 physical status is a patient with severe 
systemic illness that is a constant threat to life; higher numbers indicate more 
severe morbidity. 
*ASA or American Society of Anesthesiologists physical status is a subjective 
designation by anesthesiologists used to describe allotted anesthetic and 
surgical risk to a patient undergoing an anesthetic based on the patients 
predetermined risk factors, disease burden and acute or life threatening 
pathology)  
• 
external or internal active airway obstruction from tumor, abscess, or 
laryngeal edema,  
• 
organic or non-organic oropharyngeal anatomical defects including history of 
neck radiation 
• 
moderate to severe acute and chronic restrictive or obstructive lung diseases 
(including chronic obstructive pulmonary disease and asthma 
• 
patients that require rapid sequence intubation or with aspiration risk 
• 
cervical spine injury, previously documented difficult mask ventilation or 
intubation 
• 
BMI≥50 
• 
Vulnerable populations: Children, prisoners, pregnant patients, cognitively 
impaired adults 
5. Number of Subjects 
5.1. This is a single-site study.  
5.2. The data that would be required for a formal sample-size calculation with a reliable 
power estimate are not available. For this reason, this study will use a 2-phase 
enrollment study plan with an initial 25-patient external pilot to inform the sample 
size calculation for the main phase.  The investigators will submit a modification 
to HRRC with the planned sample size for the main phase upon completion of the 

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external pilot.  However, the investigators may begin enrolling main-phase patients 
immediately upon completion of the external pilot in order to maintain study 
momentum.  The investigators will not enroll more than 25 main-phase patients 
before receiving HRRC authorization for the modification with the updated sample 
size. 
5.3. The investigators are therefore requesting initial authorization to enroll up to 50 
patients, with the expectation that a modification will be submitted to finalize the 
sample size.  These additional participants (i.e. participants 26-50) are intended to 
allow the investigators to transition from the external pilot to the main phase while 
the modification for the final sample size is under consideration by HRRC. 
6. Study Timelines 
6.1. Describe time expectations: 
Individual patients’ participation will last less than five minutes. 
Investigators anticipate that 12 to 18 months will be sufficient to enroll the planned 
2-phase sample size. 
Study completion (analysis and preparation of manuscripts and other presentations) 
is expected to take approximately 12 months after enrollment is completed.  
7. Study Endpoints 
7.1. Describe the primary and secondary study endpoints. 
Primary outcome: Mask leakage, defined as the difference between average 
inspired and expired tidal volumes, as a percentage of inspired volume.  Patients 
will serve as their own controls; the comparison is of the difference in leakage in 
the Tegaderm™ versus baseline conditions. 
Secondary outcomes: 1. Difference in airway resistance between Tegaderm™ and 
baseline conditions, 2. Difference in peak inspiratory pressure between 
Tegaderm™ and baseline conditions, 3. Extent to which mask leakage change with 
Tegaderm™ depends on beard length. 
7.2. Describe any primary or secondary safety endpoints. 
If bag/mask ventilation is difficult and a Tegaderm™ not already in place, one will 
be placed in an effort to provide a better seal for the mask.  If ventilation continues 
to be difficult, an Attending Anesthesiologist would attempt bag mask ventilation, 
consider placing an oral airway, and follow the difficult airway algorithm (6) by 
using supraglottic airway as a rescue device if deemed necessary.  This event will 
be considered data and included in analyses.  
8. Research Setting 
8.1. Describe the sites or locations where your research team will conduct the 
research. 
The research will be conducted in the main surgical suites of UNM Hospital. 

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8.2. Identify where your research team will identify and recruit potential subjects. 
Potential subjects will be identified and recruited from investigators’ regular 
patients at the UNM surgical suites, in pre-operative holding areas.   
8.3. Identify where research procedures will be performed including any laboratory 
analytics 
All research will occur in the UNM surgical suites. 
9. Resources Available 
9.1. Investigator qualifications:  
PI Neal Gerstein MD is a board-certified anesthesiologist, Division Chief of 
Cardiac Anesthesiology and Professor at UNM.  Other investigators include 
experienced clinicians, a PhD research specialist, and medical residents; all 
investigators’ research duties are well within their usual job duties.  All research 
procedures will be performed by personnel who have appropriate training, 
experience, and authorization.   
9.2. Medical decision-makers:  
All clinical decisions will be made by appropriate providers who are duly 
authorized and credentialed to do so. 
9.3. Other resources: 
• 
UNM’s operating rooms handle a high caseload, and the investigators anticipate 
little difficulty in recruiting 60 relevant patients from among them in one 
calendar year. 
• 
Engagement in research activities is an expected part of all investigators’ job 
duties, so conducting this study is not anticipated to conflict with their clinical, 
scientific, or administrative duties. 
• 
The UNM surgical suites are equipped with the personnel, supplies, and 
equipment necessary to respond to any eventuality that may arise as a result of 
participation in this study. 
10. Prior Approvals 
10.1. The completed Departmental Review Form is included with the initial application 
for review of this protocol 
10.2. This study does not involve ionizing radiation, biological specimens, or specific 
medications.  
11. Multi-Site Research 
11.1. This is not a multi-site study.  
12. Study Procedures  
12.1. 
Provide a thorough description of all study procedures, assessments and 
subject activities in a logical and sequential format. 

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After obtaining informed written consent, patients will be pre-medicated with 1–2 mg 
of midazolam prior to entry into the operating room.  Subjects will be transferred to the 
operating room table where they will lie in the supine position with the head and neck 
placed in the sniffing position.  Mask ventilation operators will be confined to 
anesthesiology residents, Clinical anesthesiologist assistants (C-AA), and C-AA 
students all of whom are familiar with bag mask ventilation.  Mask ventilation will 
occur using a two-handed Thenar-Eminence (TE) grip without the addition of an 
oropharyngeal airway.  All operators will be instructed on how to perform this 
technique prior to patient enrollment. We will use Pressure Control ventilation mode 
on Anesthesia Ventilator machine (Dräger Perseus A500) set at 10 breathes per minute, 
I:E time of 1:2 and peak inspiratory pressure of 20 Cm H2O.  An external 
pneumotachograph device and sensors (Phillips Respironics NM3™ respiratory profile 
monitor; Respironics CAPNOSTAT® Mainstream CO2 sensor) (figure1) will be used 
to measure ventilation parameters (Vtins; ml, VtExp; ml, PPins; cm H2O, Res; cm 
H2O/L/sec) with collected data electronically saved to a dedicated flash drive 
associated with the pneumotachograph.  
 
Prior to induction airway operators (Clinical Anesthesiologist Assistants, 
Anesthesiology Residents or Anesthesiologist attendings) will be trained to create an 
opening in the TegadermTM. The steps of TegadermTM modification are as follows: 1.) 
TegadermTM will be folded in half. 2.) Two 1” cuts will be made forming an Isosceles 
triangle. 3.) TegadermTM is opened up, placed on the patient with the adhesive side 
down. Once placed the covering’s structural backing is removed so not to create any 
creases, leaving a diamond shaped mouth hole allowing face mask perimeter to make 
contact with TegadermTM. 
 
1.) 
2.)
3.) 
 
 
 
Once standard ASA monitors are applied, an adult-
sized oxygen mask (MedlineTM Anesthesia Mask) will 
be placed over patient’s face for pre-oxygenation with 
100% O2 at a rate of 10 liters/minute until measured 
expired oxygen ≥80%.  Immediately prior to 
administration of induction medications we will open 
the randomization envelope denoting which technique 
we will apply first.  General anesthesia will be induced 
with 1–3 mcg/kg bolus of fentanyl, 1.5 mg/kg of 
lidocaine, 2–3 mg/kg propofol and 0.6-1mg/kg 
Rocuronium for ideal mask ventilation conditions. The 
study interval will be specified as the period beginning 
with apnea, anesthesia induction with neuromuscular 
Figure 1: https://www.zoll.com/medical-
products/defibrillators/r-series/etco2/ 
 

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blockade to completion of one minute of mask ventilation with and without 
Tegaderm™ use. Patients will act as their own controls. Anesthesia induction and 
apnea will be defined as no voluntary respiratory effort and the absence of the eyelid 
reflex. Complete Neuromuscular blockade will be defined as Train of Four Ratio of 0/4 
with neuromuscular monitoring at the Corrugator Supercilii muscle. 
 
Once subjects are apneic and induced, 3 mask ventilation breaths will be administered 
in order to ‘acclimate’ the user to the mask and insure a proper thenar-eminence (TE) 
grip is being used.  The randomized crossover trial will be started once complete 
neuromuscular blockade is verified. Every consecutive trial will alternate between 
starting with TegadermTM use and no alteration with patients acting as their own 
controls.  Both no alteration and TegadermTM portion of exam will use the Respironics 
NM3 ™ (Respironics Deutschland, Herrsching, Germany) and CAPNOSTAT® 5 
(Phillips Healthcare corporation, Eindhoven, The Netherlands) sensors to measure 
primary outcomes: Inspired tidal volumes ( Vtins; ml ), expired Tidal Volumes of End 
Tidal CO2 (VtExp; ml) which will be used to determine predefined adequate BMV 
(Inspired Tidal Volume- Expired Tidal Volume difference of <15% defined as 
adequate) and secondary outcomes: within-patient differences between TegadermTM 
and no-alteration conditions for peak inspiratory pressures (PPins; cm H2O) and airway 
resistance (Res; cm H2O/l/sec) for 60 seconds, and facial hair grouping comparisons. 
The anesthesia machine will be set to deliver standardized pressure-controlled 
ventilation using common parameters: peak inspiratory pressure of 20 cm H2O, 10 
breaths per minute, and an inspiratory-expiratory ratio of 1:2.  These values are within 
common ranges used in standard practice, but may be modified during surgery as 
determined to be clinically appropriate by the attending anesthesiologist.  General 
anesthesia will be maintained with sevoflurane 4-6% with 100% O2 at a rate of 6 liters 
per minute.  Once data is gathered for the first part of the trial (no alteration or 
TegadermTM), we will change our technique and collect data for second 60 seconds 
component of the trial in similar fashion to initial data collection.   
 
If during the “no alteration” portion of the study we fail to establish a seal after 3 
attempts at ventilation, an Attending Anesthesiologist would assess the stability of the 
patient and, if needed, attempt bag mask ventilation, incorporate airway adjuncts, and 
follow the difficult airway algorithm. If the patient is deemed stable a TegadermTM will 
be immediately applied over the patient’s face with a hole over the mouth. The same 
operator will perform TE grip MV technique in order to establish a seal and to collect 
our data. If a subject could not be rescue ventilated after application of TegadermTM 
placement, an Attending Anesthesiologist would follow the same rescue techniques as 
described above. Once the mask ventilation trial is completed, subjects will be 
intubated and maintained under general anesthesia as usual for their anticipated 
surgery. 
 
In a hemodynamically unstable event the protocol will be halted in order to address the 
medical needs of the patient, the Attending Anesthesiologist would treat the event 
accordingly with the appropriate pharmacologic interventions.  Once the patient is 
deemed medically stable the Attending Anesthesiologist would make the decision to 

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abort or proceed with the protocol. In the event of a cardiac event or equivalent the 
protocol will be aborted and the patient will be excluded from the trial. 
 
12.2. 
Study data will be derived from the research interaction with the patient, 
and the electronic medical record (EMR). These data will be recorded on a data 
collection form that will be deidentified and associated with a unique study code.  
Data to be collected are as follows. 
12.2..1. 
Patient background information 
12.2..1.1. 
Past medical history 
12.2..1.2. 
Surgery Type 
12.2..1.3. 
Race 
12.2..1.4. 
Obstructive Sleep Apnea History 
12.2..1.5. 
Mallampati score 
12.2..1.6. 
Age 
12.2..1.7. 
Weight 
12.2..1.8. 
Height 
12.2..1.9. 
Body Mass Index 
12.2..2. 
Study information 
12.2..2.1. 
Level of the provider 
12.2..2.2. 
Paralytic 
12.2..2.3. 
Beard length (perioral) 
12.2..2.4. 
Randomization result 
12.2..2.5. 
Respiratory parameters  
 
13. Data Analysis 
13.1. Describe the data analysis plan, including any statistical procedures. 
 
Paired data (within patient differences in leakage, PPins, and airway resistance) will be 
assessed with paired t-test or Wilcoxon rank-sum test, depending on distribution 
normality. Beard condition groups will be compared on the primary outcome (leakage 
difference > 15% significant) with ANOVA or Kruskal-Wallis test, also depending on 
distribution normality. Sensitivity analysis will provide percentage of observed 
standard deviation for detection of leakage difference and a traditional power analysis 
to provide the sample size required to detect significant outcome with our intervention. 
 
13.2. Provide a power analysis, if applicable 

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The data and statistics that would be required for a formal sample-size calculation with 
a reliable power estimate are not available.  For that reason, the investigators plan a 2-
phase process.  In the first (external pilot) phase, the investigators plan to enroll 25 
participants following a published guideline (Whitehead AL, et al. Statistical Methods 
in Medical Research 2016; 25:1057-73) and use the generated data to obtain effect-size 
and standard deviation information.  Those statistics will permit a valid sample size 
calculation for the second phase, i.e. the main trial.  The investigators will submit a 
modification to HRRC with sample size justification for the main trial prior to enrolling 
any patients for it. 
 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
This section is required when research involves more than Minimal Risk to subjects. 
Describe: 
 
14.1. The PI will perform data and safety monitoring every 2 months, but the PI works 
closely with all study team members and will be kept apprised of study progress, 
including any adverse events. 
14.2. The PI will review the collected data and the Electronic Anesthesia Record which 
already includes relevant safety outcomes and patient participant EMR. Relevant 
data includes oxygenation and ventilation parameters, airway pressures, and other 
information relevant to airway management.  The data will be reviewed for 
desaturation events, elevated airway pressures, and any other adverse clinical 
outcomes related to airway management during the study.  Any such adverse 
events would be immediately apparent in the stated records.  The PI will obtain 
statistical advice as appropriate, but adverse events are expected to be sufficiently 
uncommon that they are likely to be addressed on a case-by-case basis. 
14.3. The PI will refer to the EMR as appropriate to obtain relevant context on any 
adverse events. 
14.4. Mask ventilations are routine prior to intubation and safety profiles are well 
established.  It is not anticipated that the medical literature will report new 
findings that call the safety of this study into question. 
14.5. The PI will review the incidence of adverse events related to Tegaderm use in 
this study to determine whether they exceed the incidence that would be expected 
without the use of the intervention.  If, in the PI’s opinion, adverse events occur 
and are related to the study, the PI will suspend the study and notify HRRC as 
noted in 14.6 below. 
14.6. In accordance with HRRC policy, the PI will suspend the study in the event of 
any adverse outcome that is both significant and likely due to the procedure under 
investigation, in the PI’s opinion, and report the event to HRRC for its review 
and subsequent recommendation.  
14.7. The PI will notify HRRC in the event of study termination under 14.6 above. 

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15. Withdrawal of Subjects 
15.1. The investigators have not identified any likely circumstances under which 
subjects may be withdrawn without their consent, as most study procedures occur 
after induction of general anesthesia.  However, a patient who is unable to follow 
instructions after consent but before anesthesia induction may be withdrawn 
without their consent. 
15.2. This study does not involve procedures or treatments that would require orderly 
termination plans.  The interim between consent and commencement of study 
procedures is brief, which makes voluntary patient withdrawal before surgery 
unlikely.  The investigators also believe that voluntary patient withdrawal after 
surgery is also unlikely, because all study procedures will have been completed 
by that point.  In the unlikely event of a post-surgery withdrawal, the data 
collected on that patient will not be analyzed, but the patient’s entry into the study 
will be recorded and reported as usual. 
15.3. The investigators have not identified any circumstances for partial withdrawal.  
15.4. The consent document contains information about withdrawal procedures and 
limitations. 
 
16. Data Management/Confidentiality 
16.1. Most members of the research team are physicians who interact with these and 
similarly-situated patients on a daily basis. 
16.2. The research does require the use of direct identifiers (e.g. MRN) in order to 
accurately obtain complication data and link it to procedural data. 
16.3. The research requires the use of Private Health Information (PHI), but the 
investigators will not disclose any identifiable information except as required by 
law. 
16.4. The data do not include information that is typically considered to be sensitive, 
such as HIV status, substance abuse, or criminal behavior. 
16.5. The investigators do not plan to pursue a Certificate of Confidentiality. 
16.6. All investigators have completed routine UNM Health Sciences Center (HSC) 
training on the secure management and use of patient data.  Identifiable data on 
paper forms will be maintained in a locked cabinet in a study team member’s 
Anesthesiology Department office, which is a patient-restricted area; and in 
electronic format will be stored on HSC secure servers, which are password-
protected. 
16.7. Data will be deidentified upon completion of data collection and entry into a 
spreadsheet stored on UNM HSC secure servers, but will be identifiable (via a 
linking document containing study ID numbers and MRNs) until that point in 
order to permit accurate linkage of procedural and outcome data. 

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16.8. Any questionable entries in the paper data sheets will be verified by reference to 
the EMR, as appropriate.   
16.9. Identifiable data will not be transmitted to outside entities, except as required by 
law. 
16.10. 
Identifiable data will not be collected or transported by the internet; only on 
UNM HSC secure servers. 
16.11. 
Study records will be maintained for 3 years after closure as required by 
federal regulations. 
16.12. 
Recordings of audio/video will not be used. Any photographs obtained will 
be deidentified. 
16.13. 
Data from this trial will not be shared with an external institution.  
17. Data and Specimen Banking 
17.1. Identifiable data will not be banked.  Deidentified data will be maintained as part 
of routine study records for 3 years after closure, as noted in §16.11 above. 
 
18. Risks to Subjects 
18.1. The only identified risks are of allergy to the Tegaderm™ adhesive, which is rare; 
and mild irritation, which is uncommon. The risk of bag mask ventilation causing 
aspiration of stomach contents and barotrauma are theoretical and highly unlikely 
in this study population. The risk of these events occurring do not increase with 
our protocol (addition of 2 minutes of bag mask ventilation) versus an elective 
general anesthetic as we have excluded all patients that would incur this added 
risk. All research involves risks of loss of confidentiality, inconvenience, stress, 
and emotional upset.   
18.2. The risk of allergic reaction is mitigated by performance of study procedures in 
UNMH operating rooms, which are furnished with the personnel, facilities, 
equipment, and supplies necessary to respond to any such eventuality.  It is also 
mitigated by exclusion of patients with known allergy to the product.  Risks 
associated with multiple iterations of bag/mask ventilation are mitigated by the 
presence of attending anesthesiologists, who are experts in all aspects of airway 
management. The remaining listed risks are mitigated by adherence to procedures 
as described in this document as well as routine HRRC policies/procedures. 
18.3. The investigators have not identified any aspects of this study that may carry 
unforeseeable additional substantial risks. 
19. Potential Benefits to Subjects 
19.1. Investigators have not identified any direct benefits for participants.  
20. Recruitment Methods 
20.1. Potential subjects will be recruited from among UNM Hospital surgical patients, 
who are regular patients of the investigators, in the pre-operative holding areas 

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during the routine pre-surgical consultation between the anesthesia provider and 
patient.  An investigator, who is also one of the potential participant’s treating 
physicians, will first ask whether the patient is interested in participating in 
research about airway management in bearded patients.  If the patient expresses 
interest, the study will be explained in more detail and the consent process will 
commence. 
20.2. Clinician investigators will review patients’ charts prior to surgery in the context 
of their own scheduled treatment of the patient.  Patient characteristics in the 
inclusion/exclusion criteria will be screened for to identify patients that meet such 
criteria with perioral facial hair greater than 5mm in length. 
20.3. Recruitment will be verbal only; no advertisements will be used. 
 
21. Provisions to Protect the Privacy Interests of Subjects 
Recruitment will occur in the pre-operative holding areas, which are already 
sufficiently private for confidential doctor/patient conversations.  Recruitment 
will be handled by clinicians already authorized and expected to contact 
relevant patients.  Recruitment and consent will not require the disclosure of 
information beyond routine medical information.  The patient experience will 
not be greatly modified by participation in this study; the only change is the 
additional use of Tegaderm during mask ventilation for a duration of 60 
seconds prior to intubation and the use of the pneumotachograph device in the 
preexisting anesthesia circuit to measure airflow. Participants will not be 
observed by atypical personnel. 
 
22. Economic Burden to Subjects 
22.1. Patients (or their 3rd-party payers) will be responsible for routine costs of surgery, 
but not placement of the Tegaderm.  It is not anticipated that this additional 
intervention will change the patient cost as a result of study participation. 
 
Research Procedures 
Number 
of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Tegaderm placement 
All 
 
 
      
      
 
 
      
      
 
 
Standard of Care Procedures 
Number 
of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Surgery 
All 
 
 
Anesthesia 
All 
 
 
Hospitalization (as appropriate) 
All 
 
 
Medications and supplies 
All 
 
 
      
      
 
 
 

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22.2. Patients (or third-party payers) will be responsible for any costs related to adverse 
outcomes; this is discussed in the consent form. 
23. Compensation 
23.1. Participants will not be compensated.  
24. Compensation for Research-Related Injury 
24.1. Subjects will be responsible for any costs of research-related-injury. This is 
communicated in the consent documentation. 
25. Consent Process 
25.1. Consent will be obtained prior to commencement of research activities. 
• 
An investigator will obtain consent.  All investigators have completed 
appropriate HIPAA, CITI, and related training as required by UNM HSC and 
by HRRC. 
• 
The consent process will take place in the pre-operative holding areas 
immediately after recruitment.  These areas are sufficiently private for 
confidential doctor-patient conversations.  
• 
The possibility of coercion or undue influence is reduced in several ways. All 
participants are drawn from a population that require mask ventilation.  There 
is no compensation for participation.  All prospective participants will be 
assured that there is no consequence for declining participation; participation 
is strictly voluntary. 
• 
Participation in this entails the use of and previously described intervention 
for bearded patients and one that is routinely used when complicated airways 
are encountered.  The consent decision is thus comparably complex to the 
decisions surrounding anesthesia management that are already routinely 
handled entirely within the preoperative anesthesia consultation.  The 
appropriateness of day-of-surgery consent for anesthesia studies has also been 
the topic of scientific investigation, and the results clearly indicated that 
longer intervals in which to consider participation do not automatically 
benefit participants.  This recent study (Murphy et al., “Consent for 
Anesthesia Clinical Trials on the Day of Surgery,” Anesthesiology 2016; 
124:1246-55) showed that patients approached for consent to participate in 
anesthesia-related research on the day of surgery tend to be satisfied with the 
consent process, feel that the protocol was well explained and comprehended, 
and that the setting was appropriate.  Conversely, these patients strongly 
disagreed that they were anxious at the time of consent, felt obligated to 
participate, or regretted participating.  Importantly, the use of a preadmission 
telephone call to describe the research protocol and provide extended time for 
patients to consider their participation did not change these results. 
• 
Investigators do not anticipate that ongoing consent will be at issue during 
this study, because patients’ active participation will only occur prior to 
anesthesia.  

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• 
Consenting investigators will ask prospective participants to describe the 
study briefly in their own words in order to ensure understanding. 
• 
Subjects will be given a copy of the signed consent. 
Subjects not fluent in English 
• 
The investigators will primarily enroll patients who speak English but will 
include occasional Spanish speakers as well.  A majority of UNM Hospital 
surgical patients do speak English, so relatively few patients with 
insufficient English fluency to understand the consent materials would be 
encountered during the enrollment period. The investigators anticipate that 
most non-English speakers would speak Spanish, so we will use the hospital 
translation service and the Spanish Short Form Consent document.  Patients 
who do not speak English or Spanish will not be enrolled. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative 
• 
Patients in this category will not be enrolled. 
Subjects who are not yet adults (infants, children, teenagers) 
• 
Patients in this category will not be enrolled. 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered)  
• As noted elsewhere in this protocol, the investigators will use their already-
authorized review of patient records (as part of routine clinical care; these are 
their patients) to screen for eligibility, and therefore request HIPAA waiver 
for screening purposes.  The investigators are not seeking other waiver or 
alteration of the consent process. 
26. Documentation of Consent 
26.1. A proposed consent form is included with this application. 
27. Study Test Results/Incidental Findings 
27.1. Individual Results: This study does not involve laboratory tests or other findings 
outside routine medical care.  Relevant routine information is already shared with 
patients as appropriate, and this study does not change the delivery of information 
to patients. 
27.2. Incidental Findings: The investigators do not anticipate any incidental findings 
to be generated by this study.  
28. Sharing Study Progress or Results with Subjects 
28.1. Investigators do not plan to share in-progress study results with patients. 
28.2. Investigators do not plan to share final study results with patients. 
29. Inclusion of Vulnerable Populations 

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29.1. This research does not target any of the populations typically identified as 
vulnerable. 
30. Community-Based Participatory Research 
30.1. NA. 
31. Research Involving American Indian/Native Populations 
31.1. NA 
32. Transnational Research 
32.1. NA 
33. Drugs or Devices 
33.1. This study includes the use of Tegaderm™ bandage.  In consultation with UNM 
HSC HRPO staff, the investigators believe that this study is IDE exempt. 
34. Principal Investigator’s Assurance 
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that: 
☒ The information supplied in this form and attachments are complete and correct.   
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements.  
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including: 
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap. 
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include if 
the data is entered or stored using an untrusted device or storage. 
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of 
following safeguards: access logs, encryption keys, backups, business continuity 
and disaster recovery capabilities. 
4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards. 
 
 

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Checklist Section 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
 
I. Waivers or Alterations of Consent, Assent, and HIPAA Authorization 
A. Partial Waiver of Consent for Screening/Recruitment 
NA; the primary screening criterion for inclusion is the presence of a beard, which does 
not constitute PHI.  Other inclusion/exclusion criteria are already part of the routine 
review of records conducted prior to surgery. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment 
The investigators already review relevant patients’ records for treatment purposes; these are their 
patients and this review is part of routine care.  The investigators are requesting partial waiver of 
HIPAA authorization for screening purposes.  The reviewed criteria are quite straightforward 
and do not require recording at the screening phase. 
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility? 
            
 Yes. Describe:       
            
 No 
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained: 
      
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule. 
 
      
 True 
            
 False 
 
B. Waiver of Documentation of Consent 
NA; this waiver is not being sought. 
C. Alteration of Consent 
NA; no alteration is being sought.  
D. Full Waiver of Consent/Parental Permission 

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NA  
E. Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs) 
NA  
F. Full Waiver of HIPAA Authorization 
NA  
G. Other Waiver Types 
NA 
 
II. Vulnerable Populations 
 
 
NA; vulnerable populations are not included.  
 
III. Medical Devices 
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  If 
more than one medical device is being evaluated, provide the requested information for each. 
A. Device Name:  Tegaderm dressing 
B. Manufacturer:  3M 
C. Does the research involve a Significant Risk Device under an IDE? 
 Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number and 
approval status; (2) Industry sponsor letter noting IDE number and FDA approval 
status; or (3) FDA-approved industry sponsor protocol with IDE number noted  
 No 
D. Is the research IDE-exempt? 
 Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) justifying 
why they believe the research is IDE-exempt*.   
 No 
E. Does the research involve a Non-Significant Risk (NSR) Device? 
 Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.   

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 No 
* This FDA guidance includes a description for when a device study is exempt from the 
IDE 
requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf  
**This FDA guidance includes information on how to differentiate between Significant 
Risk 
and 
Non-Significant 
Risk 
device 
studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf  
IV. Export Control: 
NA