Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
Conditions: Anesthesia
Sponsor: Ambu A/S

 
 
Protocol – Non-interventional study 
1/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
 
Prospective non-interventional evaluation of insertion and 
sealing performance of AuraOnce Disposable Laryngeal Mask 
US Version 
 
NCT04128527 
 
Version: 1.0 
 
Date: 07-OCT-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Protocol – Non-interventional study 
2/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
INTRODUCTION 
The AuraOnce is a class IIa disposable (single use, sterile) flexible supragottic airway device 
intended to maintain control of the airway during routine and emergency anaesthetic 
procedures in fasted patients. The AuraOnce was the first single moulded laryngeal mask with 
a curvature of the airway tube simulating the anatomy of the throat and was launched in 2004. 
This study is initiated to ensure that the device continues to perform as intended.  
The CIP was made according to the Council Directive 93/42 EEC of 14 June 1993 and 
amendment 2007/47/EC (1), the guidelines set out in ISO 14155 (2), ISO 14971 (3), the 
Helsinki Declaration (4) and the European Commissions General Data Protection Regulation 
(GDPR) (5).  
 
1. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
1.1 
Description 
 
The Ambu AuraOnce is intended for use as an alternative to a facemask for achieving and 
maintaining control of the airway during routine and emergency anaesthetic procedures. The 
Ambu AuraOnce may also be used where unexpected difficulties arise in connection with 
airway management. It is only intended for use by medical professionals trained in airway 
management.  
 
It is a laryngeal mask consisting of a tube with a specially shaped inflatable cuff distally, which 
conforms to the contours of the hypopharynx and with its lumen facing the laryngeal opening. 
The distal tip of the cuff presses against the upper esophageal sphincter and the proximal end 
of the cuff rests against the base of the tongue. 
 
The Ambu AuraOnce contains different versions of "U" and "EU". The only difference between 
"U" version and "EU" version is that "U" version of AuraOnce does not have an enforced tip on 
the top of the cuff while "EU" version of AuraOnce has the enforced tip.  
 
The product is single use and delivered sterile.   
 
The product concept comprises eight sizes of laryngeal masks. The correspondence between 
the product sizes and patient size is as stated in the table:  
Mask size 
Patient weight 
Maximum cuff inflation volume 
#1 / #1U 
<5 kg 
4ml 
#1½ / #1½U 
5-10 kg 
 7ml 
#2 /#2U 
10-20 kg 
10ml 
#2½ / #2½U 
20-30 kg 
14ml 
#3 / #3U 
30-50 kg 
20ml 

 
 
Protocol – Non-interventional study 
3/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
#4 / #4U 
50-70 kg 
30ml 
#5 / #5U 
70-100 kg 
40ml 
#6 / #6U 
>100 kg 
50 ml 
1.2 
Manufacturer 
Corporate Head Office & Manufacturer: 
Ambu A/S 
Baltorpbakken 13 
DK-2750 Ballerup 
Denmark 
Tel.: +45 7225 2000 
Fax: +45 7225 2050 
www.ambu.com 
1.3 
Models/type of the investigational device 
The product concept comprises eight sizes of laryngeal masks. The Ambu AuraOnce is a sterile 
and single use device. The product specifications are described in the table below. 
 
 
1.4 
Device traceability 
The site included in the study will make their daily used bronchoscopes available for the 
procedure.  

 
 
Protocol – Non-interventional study 
4/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
The site will free of charge receive 20 Ambu® AuraOnce devices in each adult size (size 3, 4 and 
5). Any devices remaining after the end of the study will be accounted for and shall be returned 
to Ambu®. 
There are no requirements regarding device accountability for CE marked devices. However, for 
logistical reasons the Sponsor will account for all devices delivered to and returned from the 
Investigators in a Device Accountability Form kept at Sponsor’s address.  
 
1.5 
Investigational device procedures 
The laryngeal mask is introduced in the routine fashion by trained staff (anesthesiologist or 
anesthesia nurse). It will be used in already planned diagnostic flexible bronchoscopy 
procedures in general anesthesia. The flexible bronchoscope is introduced through the 
laryngeal mask and special attention is paid to the cuff area including the tip. 
2. 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
The clinical investigation is an observational study designed as quality control of the AuraOnce. 
Based on experience, the sample size has been judged to be adequate to provide the 
information necessary to show a representative picture of the product quality which is the 
objective of the study. 
3. 
OBJECTIVES AND HYPOTHESES 
The objective of this study is to observe the performance of the AuraOnce through clinical 
assessment and endoscopic imaging to ensure ongoing documentation on quality of the 
product in regards to correct placement remains high.  
This is an observational study with no hypothesis. However, a success criterion is set saying 
that in 90% of the cases the AuraOnce must be correctly centred above vocal cords with no 
clinical significant air leak and using maximum three placement attempts. 
3.1 
Primary 
Primary endpoint1: 
- 
Leakage (yes/no), if yes insert signs of leakage 
3.2 
Secondary 
 Secondary endpoints2: 
- 
Questionnaire – interview to anaesthesiologist/nurse 
o 
Ease of insertion (5-point scale, very difficult to very easy) 
o 
Ease of obtaining seal (5-point scale, very difficult to very easy) 
o 
Overall performance (5-point scale, very bad to excellent) 
- 
Opening placed just above vocal cords (yes/no) correct positioning is documented by 
endoscopic picture (including POGO score) 
 
1 Primary endpoint(s) is (are) principal indicator(s) used for assessing the primary hypothesis of a clinical 
investigation. It is also used to calculate sample size. 
2 Secondary endpoints are indicators used for assessing the secondary hypotheses of a clinical 
investigation. 

 
 
Protocol – Non-interventional study 
5/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
- 
Folding of tip (yes/no) - is documented by endoscopic picture 
3.3 
Claims and intended performance 
The claims to be observed in the study is: 
- 
Ease of insertion 
- 
Tip resists folding over during insertion and plugs the upper oesophageal sphincter 
- 
Sealing 
4. 
DESIGN OF THE CLINICAL INVESTIGATION 
4.1 
General 
This study is designed as a single-center, prospective observational, non-controlled, non-
interventional study with an investigation period lasting for one day (during one bronchoscopy 
procedure). The study will take place in Denmark. 
The study will include minimum 15 adult patients planned for a diagnostic flexible 
bronchoscopy procedure in general anaesthesia using a laryngeal mask. 
The involved site will include subjects during a one month period, October 2019. However, the 
study will not be initiated before the study protocol is duly approved, i.e. by site, Ambu and 
Ethics Committee if relevant (if EC approval is not needed a written opinion from the EC must 
be obtained). If the number of subjects cannot be included in time, the sponsor will decide 
whether the study period should be extended, or the study should be closed. 
The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to 
participate in this study as it is a quality study (see section 16) where the AuraOnce is used 
within its intended use and according to normal clinical procedure. 
4.2 
Investigational devices and comparators 
4.2.1 
Device exposure 
The subjects will be exposed to the device for less than an hour. The devices used for the 
study are all CE marked and used in normal clinical practice.  
4.2.2 
Choice of comparator 
Not applicable 
4.2.3 
Other investigational devices or medications 
Apart from the AuraOnce Laryngeal mask, the following devices can be used during the 
procedure: 
- 
Flexible bronchoscope normally used for the planned bronchoscopy procedure at site.  
- 
Syringes with saline for broncho-alveolar lavage (BAL) 
- 
Biopsy forceps for transbronchial biopsy (TBB). 

 
 
Protocol – Non-interventional study 
6/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
4.2.4 
Number of investigational devices to be used 
One AuraOnce is expected to be used for each procedure. In case of device deficiencies, the 
product must be replaced, and a device deficiency form must be completed. 
4.3 
Subjects 
The clinical investigation will be conducted on minimum 15 subjects and maximum 20 subjects 
enrolled in one clinical investigation site.  
4.3.1 
Inclusion criteria 
Subjects will be enrolled responding to the following criteria: 
- 
Subjects > 18 years 
- 
Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia 
using a laryngeal mask. 
4.3.2 
Exclusion criteria 
Subjects responding to the following criteria are excluded from participation: 
- 
Subjects where use of AuraOnce cannot be clinically justified 
4.3.3 
Subject withdrawal or discontinuation 
Patients not completing the clinical procedure as intended by the investigator are considered 
as drop-outs as the evaluation form will lack information of the device. In case of drop-outs 
the study will not be completed until the minimum number of subjects is included.  
Subjects will be withdrawn from the clinical investigation for the following reason: 
a. Withdrawal by investigator for e.g. safety reasons 
The reason for withdrawal will be investigated and carefully documented in the appropriate 
section of the case report form (CRF).  
If a subject is replaced the new subject is given a new subject number.  
4.3.4 
Recruitment and point of enrolment 
The subjects (patients) included in this study are scheduled for a diagnostic flexible 
bronchoscopy procedure in general anesthesia using a laryngeal mask.  
When a subject is included, the investigator assures that the subject meets all inclusion criteria 
and none of the exclusion criteria, by checking the relevant boxes in the CRF. 
The subjects will not receive information about the study, as no patient data are obtained, and 
the CE-marked AuraOnce laryngeal mask is used within intended use. The only data to be 
obtained are evaluation forms directly related to the performance of the device, the user’s 
perception of insertion of the laryngeal mask and pictures of the placement and sealing. 
4.3.5 
Duration of the clinical investigation 
The data collection is expected to last three days within a two months period. The subjects are 
included in the study when the investigator has ensured that they fulfill the in- and exclusion 
criteria and they are completed when the bronchoscopist have confirmed the laryngeal mask 
placement (by taking a picture) and starts the planned bronchoscopy procedure. The expected 
duration of each subject’s participation is estimated to be less than one hour. 

 
 
Protocol – Non-interventional study 
7/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
4.4 
Procedures 
The site will receive the protocol, AuraOnce and case report forms (CRFs). A total of 80 Aura 
once products will be provided, included 20 laryngeal masks in each size (size 3, 4, 5). Any 
remaining products after the study will be returned to Ambu A/S. 
During normal clinical bronchoscopy procedures where general anaesthesia with a laryngeal 
mask is needed AuraOnce will be used if the subjects fulfil the in- and exclusion criteria. The 
CRF must be filled in for each subject that is enrolled in the investigation. 
The investigation period for each subject is within one day. The anaesthesiologist decides 
which size of AuraOnce should be used for each subject and places the laryngeal mask 
according to normal clinical practice at the site. 
4.4.1 
Screening 
Patients planned for a diagnostic bronchoscopy procedure under general anaesthesia at the 
investigational site will be evaluated by the anaesthesiologist to determine if AuraOnce can be 
clinically justified for the procedure. If AuraOnce can be clinically justified and the subject 
fulfils the inclusion criteria for the study, he/she will be enrolled in the study. If AuraOnce 
cannot be clinically justified or if the patient does not fulfil the inclusion criteria, he/she will be 
excluded from the investigation and receive the standard treatment off this investigation.  
4.4.2 
Randomisation  
Not applicable 
4.4.3 
Investigational procedures 
4.4.4 
Pre-examination of the airway 
- 
Before inserting the AuraOnce a pre-examination will be performed to ensure that the 
anatomy is applicable for laryngeal mask placement.  
- 
An examination of the airway will be performed and include the following measures: 
o 
Airway cleaned (yes/no) 
o 
Inter-incisor distance (normal/reduced) 
o 
Sifnificant overbite (no/yes) 
o 
Mandibular space (normal/reduced) 
o 
Cervical motion (normal/restrictede)  
o 
Short thick neck (no/yes) 
4.4.5 
Preparation for use 
- 
The device will be prepared, and size will be chosen according to users’ standard clinical 
procedure. 
4.4.6 
Insertion of AuraOnce 
- 
All participants are experienced in placement of laryngeal masks and placement will be 
performed according to standard clinical practice. 
- 
Number of attempts for correct placement will be noted in the CRF 
- 
After insertion the following information is noted in the CRF: 
o 
Leakage (yes/no) – if yes: signs of leakage are noted 
- 
After insertion the user perception of the AuraOnce placement is obtained regarding: 
o 
Ease of insertion 
o 
Ease of obtaining seal 

 
 
Protocol – Non-interventional study 
8/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
o 
Overall performance of the product 
4.4.7 
Bronchoscopy procedure 
Prior to the bronchoscopy procedure, which the patient is scheduled for, an assessment of the 
AuraOnce will be performed. 
- 
The head of the patient is placed in neutral position. 
- 
A lubricated flexible video bronchoscope is inserted through the AuraOnce. 
- 
A picture is taken of the vocal cords to assess the placement of AuraOnce 
o 
The picture is kept with the CRF 
- 
The percentage of glottic opening (POGO), defined on a scale from 0-100 (see figure 
below) is used to confirm correct placement (6). The percentage of opening seen 
indicates whether AuraOnce is able to adapt to the anatomy. 
 
           10%                      50%                      100% 
- 
A picture of the AuraOnce cuff is taken, specially focussing on the tip 
o 
The picture is printed and kept with the CRF 
o 
If any issues with the cuff is observed (especially folding) it must be described in 
the CRF. 
 
After assessing the AuraOnce the diagnostic flexible bronchoscopy procedure is performed as 
planned and the AuraOnce is removed after the procedure. The bronchoscopic procedure and 
removal of AuraOnce is not part of this investigation, and the study ends as the bronchoscope 
passes the vocal cords. 
4.4.8 
Follow-up procedures 
Not applicable 
4.4.9 
Missed follow-up 
Not applicable as no follow up is done 
4.4.10 
Lost to follow-up  
Not applicable as no follow up is done 
4.4.11 
Procedures performed by sponsor representatives 
Not applicable 
4.4.12 
Subject Identification and Confidentiality 
Each subject will be given a subject number, however all data collected will be anonymized and 
it will not be possible to identify the subject after completion of the procedure. No patient 
registration list will be created to ensure patient confidentiality. 
Data entered on the CRF are confidential and will only be available to the sponsor (including 
sponsor delegates), members of data management teams, the statistician, data monitoring 

 
 
Protocol – Non-interventional study 
9/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
board members or clinical event committee members if involved, and if requested to 
regulatory authorities. 
4.5 
Monitoring plan 
The sponsor is responsible for ensuring appropriate monitoring of the clinical investigation 
activities. 
During the period of the investigation a representative of the sponsor, Annette Bitz, +45 2080 
1620 or Anna Charlotte Lundgaard, +45 2964 3748, will act as monitor/s of the investigation. 
The investigator may contact Annette Bitz or Anna Charlotte Lundgaard at any time. The 
monitor will be the primary contact for the principal investigator and clinical investigation site 
personnel. 
Monitoring activities are mandatory as per good clinical practice, however the extend and 
depth of these activities depend on the criticality of the clinical investigation, speed of 
enrolment, the experience of the clinical investigation site personnel in carrying out clinical 
investigations and specific study designs. 
For the purpose of this clinical investigation the below described monitoring procedures have 
been determined. 
4.5.1 
Monitoring visits 
The monitor/s is responsible for planning the monitoring visit including initiation visit, routine 
visit and close-out visit. 
4.5.2 
Initiation visit:  
The initiation visit will be performed before the study is initiated. The aim of this meeting is to 
train the investigator(s) on the investigation procedure, perform a page-by-page revision of 
the CIP with emphasis on reporting of deviations, adverse events and how to complete the 
CRF. Moreover, contract signature and written EC opinion will be verified, and monitoring 
arrangements will be discussed. It is required that all investigators participating are present in 
this meeting.  
4.5.3 
 Routine Visit 
Monitoring of the CRFs will be performed after the first day of data collection (4-7 subjects are 
expected to be completed at this point). Ongoing monitoring will be performed by the observer 
who will be presented during all data collections. The aim of these routine visits is to 
corroborate the clinical investigation progress. CRF will be monitored for completeness and 
correctness of the data. It is required that at least one investigator is available during 
monitoring visits. 
4.5.4 
Close-out visit:  
The close-out visit will be performed when the data collection has been completed. The aim of 
this meeting is to close financial aspects, check that all essential documents are complete and 
up to date, all outstanding queries are resolved, current state of all adverse events is 
documented, arrangement for achieving all clinical investigation documentation, device 
accountability and collection of the original CFR. 

 
 
Protocol – Non-interventional study 
10/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
4.5.5 
Source data verification 
No source data verification will be performed for this study, as there will be no access to the 
patient file. Name, address/contact information and personal identification number (CPR) will 
not be collected for this study. To ensure correct data collection and high-quality data, an 
observer dedicated for the study will be available during the entire data collection to double 
check that all data is noted correct. It will be the same observer during the entire data 
collection.   
5. 
AUDIT 
Audit of the clinical investigation may be conducted by the sponsor or third parties designated 
by the sponsor to evaluate compliance with the CIP, written procedures and international 
standards (2). These audits may cover all involved parties, systems and facilities and are 
independent from routine monitoring. The aims of the audit are: 
• 
to assess the effectiveness of the monitoring,  
• 
whenever there are repetitive deviations from the CIP,  
• 
to prepare the investigation for a regulatory inspection,  
• 
when requested by a regulatory authority, etc. 
Audits may be performed during the investigation. All parties will be informed in advance of 
the date and objective of the audit. 
6. 
STATISTICAL CONSIDERATIONS 
6.1 
Sample size 
No sample size calculations have been performed for this study as the data obtained only will 
form basis for quality control of the performance of the Ambu AuraOnce disposable Laryngeal 
Mask. 
 
The study will include a minimum of 15 and a maximum of 20 adult patients already scheduled 
for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. 
6.2 
Pass/fail criteria 
In 90% of the cases the AuraOnce must be correctly centred above vocal cords with no clinical 
significant air leak and using maximum 3 placement attempts. 
6.3 
Statistical analyses 
6.3.1 
General aspects  
Descriptive statistics of all measured outcomes are provided (median and range or mean and 
standard deviation as appropriate). The study is not sufficiently powered to explore patient 
characteristics related to unsuccessful placement of laryngeal mask.  
6.3.2 
Handling of dropouts and missing data 
Patients not completing the clinical procedure as intended by the investigator are considered 
as drop-outs as the evaluation form will lack information of the device. Drop-outs are 

 
 
Protocol – Non-interventional study 
11/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
compensated in the sample size estimation to ensure that a complete data set is collected for 
minimum 15 patients. Missing data will not be imputed. 
7. 
DATA MANAGEMENT 
A database will be set up, and two individuals at Ambu A/S will perform double data entry. Any 
unclear data points will be highlighted in a data clarification form that will be sent to the 
responsible investigator for clarification. An error list will be generated, and errors corrected by 
Ambu A/S staff.  
7.1 
Data review and cleaning 
The CRF must be filled in for each subject that is included in the investigation. 
The CRF is in English and should be filled in English when possible.  
Missing data not recorded on the day of the procedure should be filled in later accompanied by 
date and signature. Data that are evaluated as incorrect by investigator should be crossed 
over with ink allowing the “old data” to be seen (example). The investigator shall then write 
the corrected data, signed and dated. 
The principal investigator at the clinical site will perform primary data collection by entering 
the data into the CRF. Only the principal investigator or other pre-designated clinical 
investigation site personnel will be authorized to enter data. 
The sponsor’s designated monitor shall ensure appropriate training on data entry is provided 
prior to the start of the clinical investigation to all site personnel involved. 
The principal investigator can delegate tasks to his/her collaborators, however the roles and 
responsibilities as time period of involvement for each clinical site personnel must be 
documented on the site personnel log as well as training received before getting involved with 
the clinical investigation. 
Clinical site personnel not trained and not officially identified by his/her name and signature 
cannot enter data in the CRFs. 
The principal investigator shall approve and date each CRF. 
The monitor shall verify all critical data points and issue queries for the authorized clinical site 
personnel to answer. 
A CRF section shall be considered complete when all data are completed, verified by the 
monitor, outstanding queries resolved and signed off by the principal investigator. 
A critical quality control will be performed continuously by the designated observer at the site. 
7.2 
Data retention 
The sponsor and principal investigator shall maintain the clinical investigation documents as 
required by the applicable regulatory requirements. For non-implants the investigator binder, 
including CIP, CIR and copies of CRF’s, , must be kept on site for at least 5 years after the 
clinical investigation report has been signed. 
The sponsor will file original CRFs for rest of the products’ lifetime + 10 years. Moreover, 
adverse event forms, statistical analysis, agreements, approvals, investigators’ CVs, CIP, and 
CIR will also be filed. 
 
 

 
 
Protocol – Non-interventional study 
12/13 
Project/Product Name: 
Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
8. 
DEVICE ACCOUNTABILITY  
The site included in the study will make their daily used bronchoscopes available for the 
procedure.  
The site will free of charge receive 20 Ambu® AuraOnce devices in each of the sizes used for 
adults (size 3, 4, 5 and 6). Any devices remaining after the end of the study will be accounted 
for and shall be returned to Ambu®. 
There are no requirements regarding device accountability for CE marked devices. However, for 
logistical reasons the Sponsor will account for all devices delivered to and returned from the 
Investigators in a Device Accountability Form kept at Sponsor’s address.  
9. 
STATEMENTS OF COMPLIANCE 
The clinical investigation will be conducted according to the guidelines established in the 
Declaration of Helsinki (4). Good clinical practice 
The clinical investigation processes will comply with good clinical practice as outlined in ISO 
14155 (2). 
9.1 
Regulatory compliance 
The clinical investigation processes shall be performed in compliance with all applicable 
regulatory requirements in addition to the above defined requirements for good clinical 
practices. Where regulatory requirements are less or more stringent than the requirements 
outlined in ISO 14155 (2) the most stringent requirements will need to be complied with. 
This includes the Council Directive 93/42 EEC of 14 June 1993 and amendment 2007/47/EC 
(1). 
9.2 
Patient information 
Not applicable for this study. 
9.3 
Informed consent 
Not applicable for this study. 
10. 
LIST OF REFERENCES 
1.  
European Council. Council Directive 93/42 EEC of June 1993 concerning Medical Devices. 
Vol. L 169, Council Directive 93/42/EEC. 1993.  
2.  
Dansk Standard. Clinical investigation of medical devices for human subjects – Good 
clinical practice. Vol. 3. 2012.  
3.  
Dansk Standard. Medical devices – Application of risk management to medical devices. 
Vol. 6. 2012.  
4.  
The World Medical Association. Wma Declaration of Helsinki – Ethical Principles for 
Medical Research Involving Human Subjects. 2013.  
5.  
The European Parliment and The Council of the European. Regulation (EU) 2016/679 of 
the European Parliament and of the Council of 27 April 2016 on the protection of natural 

 
 
Protocol – Non-interventional study 
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Study ID: 
AuraOnce performance observation 
CIS-016 
  07-OCT-2019 
 
 
 
 
persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (General Da. Off J Eur Union. 
2016;(April):88.  
6.  
Levitan, RM; Ochroch, EA; Kush, S; Shofer, FS; Hollander J. Assessment of airway 
visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg 
Med. 1998;5(9):919–23.