Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
Phase: NA
Conditions: Anesthesia, Surgery
Sponsor: University of Minnesota

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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Template Revised On: 02/28/2019 
INSTRUCTIONS: 
 
Protocol Title 
Comparison of Ambu Auragain and I-Gel Supraglottic Airways 
in adult patients at an Ambulatory Surgery Center 
Principal 
Investigator/Faculty 
Advisor 
Name: Jacob Hutchins 
Department: Anesthesiology 
Telephone Number: 612-624-9990 
Email Address: hutc0079@umn.edu 
Student 
Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
HRPP Scientific Assessment 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
4 3/8/2021 
 
PROTOCOL COVER PAGE 
 
 
 
 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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Template Revised On: 02/28/2019 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
2 2/12/2020 
HRPP Scientific Assessment added 
to cover page and combined 
consent/HIPPA form clarified in 
section 5.4 
No 
2 
3 6/3/2020 
Addition of e-consent process 
No 
3 
4 3/8/2021 
LMA cuff inflation adjustment 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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Table of Contents 
 
1.0 
Objectives 
5 
2.0 
Background 
5 
3.0 
Study Endpoints/Events/Outcomes 
5 
4.0 
Study Intervention(s)/Investigational Agent(s) 
5 
5.0 
Procedures Involved 
5 
6.0 
Data and Specimen Banking 
7 
7.0 
Sharing of Results with Participants 
7 
8.0 
Study Population 
7 
10.0 Local Number of Participants 
9 
11.0 Local Recruitment Methods 
9 
12.0 Withdrawal of Participants 
9 
13.0 Risks to Participants 
10 
14.0 Potential Benefits to Participants 
10 
15.0 Statistical Considerations 
10 
16.0 Confidentiality 
11 
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
11 
18.0 Provisions to Protect the Privacy Interests of Participants 
11 
19.0 Compensation for Research-Related Injury 
12 
20.0 Consent Process 
12 
21.0 Setting 
13 
22.0 Multi-Site Research 
13 
23.0 Resources Available 
13 
24.0 References 
13 
 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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ABBREVIATIONS/DEFINITIONS 
● LMA: laryngeal mask airway 
● OLP: oropharyngeal leak pressure 
 
 
 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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Template Revised On: 02/28/2019 
1.0 
Objectives 
1.1 Purpose: The purpose of this study is to determine if an I-gel LMA has a 
higher oropharyngeal leak pressure compared to an Ambu Auragain in 
adult patients in an ambulatory surgery center.  
2.0 
Background 
2.1 Significance of Research Question/Purpose: This study will help to 
determine if the use of I-gel LMA has a clinical advantage over the Ambu 
Auragain LMA.   
2.2 Preliminary Data: Existing Literature: A previous study in pediatric patients 
demonstrated that I-gel has a higher OLP compared to Ambu auragain.  A 
study performed in adult patients undergoing laparoscopic surgery 
demonstrated no significant difference between the two LMAs OLP.  No 
studies have compared the two in a multispecialty ambulatory surgery 
center in patients undergoing general non laparoscopic surgery.  
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: OLP immediately after placement 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): Time to placement, insertion 
attempts, first attempt success rate, ease of insertion, number of mid case 
adjustments, sore throat upon discharge from recovery room and at 24 
hours after surgery analyzed using NRS 0-10 scale, and blood staining of 
LMA. 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description: Patients who are scheduled for elective ambulatory surgery 
under general anesthesia will be randomized to one of two groups.  Group 
1 will receive an I-gel LMA and group 2 will receive an Ambu Auragain LMA. 
4.2 Drug/Device Handling: The I-gel and Ambu auragain will be stocked in the 
anesthesia carts as they currently are.    
4.3 Biosafety: N/A 
4.4 Stem Cells: N/A 
 
5.0 
Procedures Involved 
5.1 Study Design: This is a level I randomized prospective outcomes study 
comparing two groups of patients.  All patients scheduled for general 
anesthesia at the M Health Ambulatory Surgery Center who are 
appropriate for an LMA will be approached for the study. Once enrolled 
patients will be randomized 1:1 between the groups based on a 
randomization schedule generated before study initiation using permuted 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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block randomization with blocks of sizes 2, 4, and 6 used in equal 
proportion (i.e., 1:1:1) to ensure approximate balance at any point in the 
study between the two groups.  Patients in group 1 will receive an I-gel 
LMA.  Those in group 2 will receive an Ambu Auragain LMA.  A standard 
anesthetic induction will take place using propofol, lidocaine, 
dexamethasone, and ondansetron.  The LMA will be placed by an 
experienced anesthesia provider.  Once absence of lid reflex is confirmed, 
the LMA will be placed according to instructions from the LMA such that 
the patient is supine with head in sniffing position.  A water-based 
lubricant will be used on the LMA to ease insertion.  The ambu auragain 
will be inflated to a pressure of 60cmH20.  Muscle relaxant will not be used 
in any patient and maintenance of anesthesia will be with propofol 
infusion.  A research assistant or another anesthesia provider will be in the 
room to capture all data points. OLP will be measured immediately after 
insertion.  This will be accomplished by closing the expiratory valve while 
keeping fresh gas flow at 3 liters/minute until equilibrium is reached.    
5.2 
Study Procedures: Patients will be approached on the day of surgery about 
participating in the trial.  This will be done as soon as they arrive at the ASC 
to allow adequate time for them to review the study procedures and 
consent forms.  All questions will be answered and patients will be ensured 
that they have adequate time to review and understand all study 
procedures.  Patients undergoing all surgical procedures with general 
anesthesia appropriate for an LMA will be eligible to participate.   Once 
enrolled patients will be randomized to one of two groups.  Patients in 
group 1 will receive an I-gel LMA.  Those in group 2 will receive an Ambu 
Auragain LMA.  A standard anesthetic induction will take place using 
propofol, lidocaine, dexamethasone, and ondansetron.  The LMA will be 
placed by an experienced anesthesia provider.  Once absence of lid reflex is 
confirmed, the LMA will be placed according to instructions from the LMA 
such that the patient is supine with head in sniffing position.  A water-
based lubricant will be used on the LMA to ease insertion.  The ambu 
auragain will be inflated to a pressure of 60cmH20.  Muscle relaxant will 
not be used in any patient and maintenance of anesthesia will be with 
propofol infusion.  A research assistant or another anesthesia provider will 
be in the room to capture all data points. OLP will be measured 
immediately after insertion.  This will be accomplished by closing the 
expiratory valve while keeping fresh gas flow at 3 liters/minute until 
equilibrium is reached.  Once in the recovery room the patient will be 
asked about a sore throat immediately prior to discharge.  Patient will also 
be called 24 hours after surgery to evaluate sore throat analyzed using NRS 
0-10 scale.  
Baseline demographics such as surgical procedure, intraoperative opioids, 
surgical procedure length, BMI, weight, age, and sex will be recorded.   

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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5.3 Study Duration: Once ready to discharge from PACU the patient will end 
study participation with one follow up call on the day after surgery.  The 
study should take 1 month to enroll and another 2 months for study 
analysis. 
5.4 Individually Identifiable Health Information: This study does involve PHI, 
please see combined consent/HIPAA form. 
5.5 Use of radiation: N/A 
5.6 Use of Center for Magnetic Resonance Research: N/A 
6.0 
Data and Specimen Banking 
6.1 Storage and Access: All study data will be stored on excel spreadsheets 
stored in Box. Only the PI and members of the research team will have 
access to the data. 
6.2 Data: The data from this study will be collected both from Epic and directly 
from the patient. The data collected includes: demographic data, age, 
weight, ASA class, duration of surgery, length of stay in recovery room both 
phase 1 and 2, time to place LMA, number of attempts, ease of LMA 
insertion, blood staining, sore throat prior to discharge and at 24 hours 
post surgically, and any adverse events. 
7.0 
Sharing of Results with Participants 
7.1 Study results will not be shared with participants.  De-identified study data 
may be shared with the peer-reviewed journal.  
8.0 
Study Population 
8.1 Inclusion Criteria: Adult patients aged 18-80 undergoing outpatient 
ambulatory surgery under general anesthesia that is amenable to LMA. 
8.2 Exclusion Criteria: Patients under the age of 18, non-English speaking 
patients, patients with abnormal airway anatomy 
8.3 Screening: Patients will be screened by looking at the surgical schedule.  
They will be contacted by the research team ahead of time and have the 
study introduced on the morning of surgery.  They will have adequate time 
to evaluate the study and read through the consent and ask questions.   
9.0 
Vulnerable Populations 
9.1 
Vulnerable Populations:  
 
Population / Group 
  
Children 
Excluded from Participation 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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Pregnant women/fetuses/neonates 
Excluded from Participation 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent and/or 
adults with diminished capacity to 
consent, including, but not limited to, 
those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, and 
behavioral disorders 
Excluded from Participation 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Excluded from Participation 
Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised social 
group 
Excluded from Participation 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
Excluded from Participation 
Individual or group that is approached for 
participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is disadvantaged 
in the distribution of social goods and 
services such as income, housing, or 
healthcare. 
Excluded from Participation 
Individual or group with a serious health 
condition for which there are no 
satisfactory standard treatments. 
Excluded from Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded from Participation 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
Excluded from Participation 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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consent to research or decision to 
continue in research. 
9.2 
Additional safeguards: N/A 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: 165 
11.0 Local Recruitment Methods 
11.1 Recruitment Process: Patients will be recruited from the group of adult 
patients undergoing surgery at the University of Minnesota Ambulatory 
Surgery Center.  On the day of surgery as soon as they are checked in, 
patients will be informed of a research opportunity by a member of the 
clinical care staff, including the check-in staff, nursing staff, or member of 
the anesthesiology team, and asked if they are interested in talking with a 
member of the research team.  A research team member will then explain 
the study and present the consent form.  All patients will have sufficient 
time to review the consent and ask questions and go over the potential 
risks of the study with the research team as they arrive several hours prior 
to the procedure.  If they decide to participate they will be consented and 
given a copy of the consent form for their records. 
11.2 Identification of Potential Participants: Patients will be identified by 
members of the research team by evaluating the surgical schedule.  
Patients who have opted out of research will not be approached.  Patients 
who agree to participate will sign a consent and HIPAA authorization form.   
11.3 Recruitment Materials: N/A 
11.4 Payment: No payment will be provided to patients.  
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances: Subjects who have consented and for some 
reason choose not to participate will be withdrawn and a notation will be 
made in the study records and these people will be considered screen 
failures.  The surgeon may choose to withdraw the patient from the study 
prior to surgery for any medical reason or if they suffer a major life-
threatening adverse event. 
12.2 Withdrawal Procedures: If the patient is withdrawn from study prior to the 
procedure, they will be noted in study records as screen failures. If they 
undergo the procedure and they decide they no longer want to be a part of 
the study or withdrawn by the physician, they will be withdrawn and no 
further data will be collected.  This will also be noted in the study 
documentation. 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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12.3 Termination Procedures: If the study is terminated for any reason, or there 
are more than 5% major adverse events the data that is already collected 
will be stored in a secure location only accessible to research personnel on 
this study.  No further data will be collected if the study is terminated.  
13.0 Risks to Participants 
13.1 Foreseeable Risks: This study has the following risks: None as both are FDA 
approved LMA devices and routinely used in clinical practice. 
13.2 Reproduction Risks: N/A 
13.3 Risks to Others: N/A 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: None.  
15.0 Statistical Considerations 
15.1 Data Analysis Plan: We plan to collect our data using excel which will be 
maintained in the box.  When the study is completed and ready for 
statistical analysis the data will be shared with our staff statistician. 
15.2 Power Analysis: Previous studies on OLP have shown that there was a 
mean difference between i-gel and AuraGain in OLP immediately after 
insertion in pediatrics of -5.9 cmH2O (95% CI: -8.5 to -3.3) [Mihara EJA 2019 
with estimated SD of 4.00 for AuraGel and 8.20 for i-gel] or an estimated 
mean difference of -1.8 cmH2O (95% CI: -3.6 to 0.01) [Sabuncu SMJ 2018 
with estimate SD of 3.56 for AuraGel and 4.20 for i-gel]. The table below 
shows the total sample size needed based upon the reported standard 
deviations from each study to detect a difference of at least 3 cmH2O in 
OLP between AuraGel and i-gel: 
Power 
AuraGel SD 
i-gel SD 
Total Sample Size 
80% 
3.56 
4.20 
56 
4.00 
8.20 
148 
90% 
3.56 
4.20 
74 
4.00 
8.20 
198 
15.3 Statistical Analysis: This study data will be de-identified and shared with 
our staff biostatistician to be analyzed.  The statistician will be provided the 
protocol so they are able to analyze for primary and secondary objectives.  
Continuous data will be summarized with mean (standard deviation) or 
median (interquartile range) and categorical data will be summarize by 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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count (percent). Normality will be evaluated with both the Shapiro-Wilk 
test and graphical evaluation. Univariate comparisons between groups will 
use t-tests or Mann-Whitney U-tests, as appropriate for normality, to 
compare continuous variables and chi-squared or Fisher’s exact tests to 
compare categorical variables between groups. Linear regression models 
will be explored to adjust for variables that are imbalanced after 
randomization or other covariates that may be clinically relevant. 
15.4 Data Integrity: All patients will be assigned a unique patient identifier.  The 
data that will be sent to the statistician will be de-identified.  
16.0 Confidentiality 
16.1 Data Security: All paper documents and consent forms will be stored in a 
locked cabinet in the anesthesia research office in B573 Mayo.  All study 
data will be stored electronically in Box and only the PI and members of the 
research team will have access to the data.  
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
17.1 Data Integrity Monitoring: The PI, co-investigators, and research assistants 
will all have access to the study data stored in the University’s Box storage 
system. All the research assistants have experience collecting study 
information. The PI of the study will periodically review the study data to 
ensure accuracy and completeness of study data. 
17.2 Data Safety Monitoring: The Department of Anesthesiology has established 
a Data and Safety Monitoring Committee consisting of several staff 
anesthesiologists which include persons who are board certified as pain 
specialists. Data will be transmitted in box to persons on the board on a 
monthly basis for review.  If there are patterns of adverse events, the 
board will meet as needed and provide recommendations. 
All safety data will be collected on a case report form and transferred into 
an excel spread sheet that will be stored in box. 
The data will be reviewed on a regular basis (weekly) by the PI and 
research staff.  If there are consistent complications noted a meeting will 
be convened by the DSMB for recommendations. 
The statistician uses R or SAS for analysis of safety data to determine 
whether harm is occurring.  Most likely a regression analysis will be 
performed to see which event is most likely the contributor for the 
complications.  Also, a chi-square analysis may be performed; all 
dependent on data variability. 
18.0 Provisions to Protect the Privacy Interests of Participants 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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18.1 Protecting Privacy: Patients will be asked if this is a good time to answer 
questions.  All patients will have the right to refuse to answer questions 
when asked.  All data will stored using a unique study identifier.  
18.2 Access to Participants: All patients will be required to sign a consent that 
states their privacy of the data being collected.  In addition, they are 
required to sign a HIPAA consent that further describes the data being 
collected.  They will be informed that data is stored and reviewed in box 
which is HIPAA compliant and that only study personnel have access.  
19.0 Compensation for Research-Related Injury 
19.1 Compensation for Research-Related Injury: In the event that this research 
activity results in an injury, treatment will be available, including first aid, 
emergency treatment, and follow-up care as needed.  Care for such injuries 
will be billed in the ordinary manner, to the patient and/or insurance 
company.  
19.2 Contract Language: N/A 
20.0 Consent Process 
20.1 Consent Process (when consent will be obtained): Patients will be 
identified in the pre-operative time period by the research team on the day 
of surgery. As soon as they enter the pre-operative room, an 
anesthesiologist will mention the study and ask permission for a research 
team member to discuss it further if they are interested. If an 
anesthesiologist is not available when they are roomed, check-in or nursing 
staff will mention the study and ask the patient if a research member can 
discuss it with them further. If they are interested they will meet a research 
member and be presented with a combined Health and Insurance 
Portability and Accountability Act (HIPAA) and study consent form. The 
patient will review the forms with the surgeon, research staff, or 
anesthesiologist, with the REDCap e-consent process being 
preferentially used. They will be reminded that participation is completely 
voluntary, and that they may stop participation at any time without 
question or penalty. The research team will answer any questions that they 
may have about the study. If the patient decides to participate, they will be 
asked to sign the consent and HIPAA form. One copy will be saved for study 
records, and the subject will be provided with a copy of the forms for their 
own records.  
20.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained): N/A 
20.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained): N/A 
20.4 Non-English Speaking Participants: N/A 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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20.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): N/A 
20.6 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: N/A 
20.7 Adults Unable to Consent: 
● 
Permission: N/A 
● 
Assent: N/A 
● 
Dissent: N/A  
21.0 Setting 
21.1 Research Sites: Patients will be consented and care will take place at the M 
Health ASC.   
21.2 International Research: N/A 
22.0 Multi-Site Research 
● 
N/A 
23.0 Resources Available 
23.1 Resources Available: Research assistants are available to aid in consent and 
data acquisition. All research assistants will be familiar with the study 
protocol and have experience working with similar studies. 
We plan to enroll 148 patients and consent 165, assuming around 10% 
drop out. This center performs approximately 100 surgical procedures 
weekly. 
We plan to conduct this study over 4 weeks.  Enrollment and data 
collection will be completed at this time.  Statistical Analysis will take 
approximately one month to complete. 
All procedures will be performed in the clinical facilities at the MHealth 
Clinics and Surgery Center.  Data storage and analysis will be done using 
desktop equipment which is available at the Research Office B573 Mayo. 
In the event that this research activity results in an injury, treatment will be 
available, including first aid, emergency treatment and follow-up care as 
needed. Care for such injuries will be billed in the ordinary manner, to the 
patient and/or insurance company. All study personnel will be adequately 
trained by the Principle Investigator on the study protocol and study 
conduct.  A log will be maintained to track which personnel are trained.  A 
delegation of authority log will also be maintained to track which personnel 
are responsible for specific duties. 
24.0 References 
1. Mihara T et al. Comparison of the clinical performance of i-gel and Ambu 
Auragain in children. Eur J Anaesthesiol 2019;36:411-417 

PROTOCOL TITLE: Comparison of Ambu Auragain and I-Gel Supraglottic Airways in 
Adult Patients at an Ambulatory Surgery Center 
VERSION DATE: 4 3/8/2021 
 
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2. Sabuncu U et al. Auragain and i-Gel laryngeal masks in general anesthesia for 
laparoscopic cholecystectomy. Saudi Med J. 2018;39:1082-1089