Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair
Phase: NA
Conditions: Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: LMA in Lap Hernia 
 
STUDY# 2580 
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PROTOCOL TITLE:  
Laryngeal mask airway versus endotracheal intubation for laparoscopic inguinal hernia repair 
(LMA in Lap Hernia) 
PRINCIPAL INVESTIGATOR: 
Emily Weisberg, MD 
Department of Anesthesiology 
816-234-3464 
eweisberg@cmh.edu 
 
IND/IDE NUMBER: N/A 
 
VERSION NUMBER/DATE: 
Version 3 
 
 
 
 
 
 
 
Date:02/12/23 
 
REVISION HISTORY 
 
This Revision History table is provided for the benefit of study team version control.  If 
this table will not be useful please delete it. 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
1/10/2023 
Initial IRB submission 
N/A 
1.1 
1/26/2023 
Addressed ORI clarifications 
N/A 
2 
7/3/2023 
Add Spanish speakers 
Translation  
3 
02/12/2024 
Sample size modification 
N/A 
 
 
 
 
 
 
 

SHORT TITLE: LMA in Lap Hernia 
 
STUDY# 2580 
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Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Endpoints 
5.0 Study Design 
6.0 Study Interventions 
PARTICIPANT MANAGEMENT 
7.0 Inclusion and Exclusion Criteria 
8.0 Local Number of Participants 
9.0 Screening and Recruitment Methods 
10.0 Surveys and Psychometric Testing 
11.0 Additional Study Activities 
12.0 Follow-Up 
13.0 Genetic Analysis Information 
14.0 Sharing of Results with Participants 
15.0 Risks to Participants 
16.0 Potential Benefits 
17.0 Investigator Assessment of Risk/Benefits Ratio 
18.0 Payment, Reimbursement and Tangible Property Provided to Participants 
19.0 Compensation for Research-Related Injury 
20.0 Economic Burden to Participants 
21.0 Parental Permission and Adult Consent Process 
22.0 Assent of Pediatric Participants 
23.0 HIPAA and Confidentiality 
24.0 Provisions to Protect the Privacy Interests of Participants 
25.0 Withdrawal of Participants 
DATA MANAGEMENT 
26.0 Data Collection 
27.0 Adverse Events and Unanticipated Problems 
28.0 Statistical Analysis 
29.0 Data and Specimen Management 

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30.0 Storage/Banking of Data and Specimens for Future Research 
31.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
DATA MANAGEMENT 
32.0 Settings and Locations 
33.0 Multi-Site Research 
34.0 International Research 
ADDENDUMS 
Addendum A: Waiver of Documentation of Permission/Consent 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
Addendum C: Non-English Speaking Participants 
Addendum D: Surrogate Decision Maker Consent 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
 

SHORT TITLE: LMA in Lap Hernia 
 
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STUDY INFORMATION 
1.0 Study Summary 
 
Study Title 
Laryngeal mask airway versus endotracheal intubation for 
laparoscopic inguinal hernia repair 
Study Design 
Prospective Randomized 
Primary Objective 
Evaluate the effectiveness of LMA versus ETT for patients 
undergoing laparoscopic inguinal hernia repair by 
measuring SpO2 at 3 standardized timepoints 
Secondary Objective(s) 1. Evaluate EtCO2 in both groups at three standardized 
timepoints 
2. Evaluate peak airway pressures in both groups at three 
standardized timepoints 
3. Documentation of laryngospasm occurrence in both 
groups  
Study Population 
12 mo- 8 yo patients undergoing laparoscopic inguinal 
hernia repair at CMH or CMK 
Study Duration for 
Individual Participants 
Single visit during which inguinal hernia repair is performed 
Study Specific 
Abbreviations/ 
Definitions  
LAR – Legally Authorized Representative 
LMA – Laryngeal Mask Airway 
ETT- Endotracheal tube 
 
 
2.0 
Objectives* 
2.1 
Purpose, specific aims or objectives:  Describe the purpose, specific aims, 
or objectives. If more than one objective be sure to list separately. 
 
This study aims to evaluate the effectiveness during general anesthesia of 
laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia 
repair. 
 
2.2 
Hypothesis:   Use of laryngeal mask airway is not inferior to the use of 
endotracheal intubation for patients undergoing laparoscopic inguinal hernia 
repair.   
 
 
3.0 
Background* 

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3.1 
Describe the relevant prior experience and gaps in current knowledge. 
Children undergoing laparoscopic inguinal hernia repair typically received 
general anesthesia with endotracheal intubation.  There are limited studies 
looking at the use of laryngeal mask airway for short laparoscopic procedures in 
pediatric patients.1,2  
3.2 
Describe any relevant preliminary data. 
There are limited pediatric literature evaluating the use of laryngeal mask airway 
for laparoscopic procedures compared with traditional endotracheal intubation.1  
This study aims to add to this literature in providing information comparing the 
two techniques.   
3.3 
Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how it will add to 
existing knowledge. 
The rationale for this study is to show that general anesthesia with laryngeal mask 
airway is an effective and non-inferior technique compared with general anesthesia 
with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal 
hernia repair and may offer benefits in terms of efficiency of care and respiratory 
complications.  
 
References 
1. Nevešćanin A, Vickov J, Elezović Baloević S, Pogorelić Z. Laryngeal Mask 
Airway Versus Tracheal Intubation for Laparoscopic Hernia Repair in 
Children: Analysis of Respiratory Complications. J Laparoendosc Adv Surg 
Tech A. 2020;30(1):76-80. doi:10.1089/lap.2019.0382 
2. Asida SM, Ahmed SS. Ease of Insertion of the Laryngeal Mask Airway in 
Pediatric Surgical Patients: Predictors of Failure and Outcome. Saudi Journal 
of Anesthesia. 2016;10(3):295-300. doi: 10.4103/1658-354X.174898 
 
4.0 
Study Endpoints 
4.1 
Describe the primary and secondary study endpoints. 
The primary endpoint of this study will be SpO2 measured at 3 standardized 
timepoints.  
 
 
 
Secondary endpoints will include: 
• SpO2 less than 90% 
• End tidal CO2 measurement at 3 standardized timepoints 
• Peak airway pressures measured at 3 standardized timepoints 

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• Occurrence of laryngospasm 
 
4.2 
 
The safety endpoint would be conversion to general endotracheal anesthesia. 
 
5.0 
Study Design* 
5.1 
Study Design:  This will be a single institution prospective randomized 
study.  Patients preparing for laparoscopic inguinal hernia repair (and meeting 
other inclusion criteria), whose parent or LAR provides permission to participate 
in the study, will be randomized to receive either general anesthesia with 
laryngeal mask airway placement or endotracheal tube placement and their data 
will be recorded.  Patients who choose not to participate will be given either 
standard treatment per their assigned anesthesiologist.   
  
5.2 
Table of Events: n/a 
 
6.0 
Study Interventions* 
6.1 
Description:  In this study, patients will undergo general anesthesia for 
laparoscopic inguinal hernia repair.  The study intervention being evaluated is 
the placement of laryngeal mask airway instead of endotracheal intubation.  
Both LMA and endotracheal intubation are standard care anesthesia practices at 
CMH for various procedures, including sometimes laparoscopic hernia repair.  
This study will randomize the airway, but all other anesthesia drugs and 
procedures remain the same in both groups.  
 
6.2 
Behavioral Intervention: N/A 
6.3 
Drugs, Biologics, or Devices:  No experimental drugs or devices will be 
used in this study.   
 
PARTICIPANT MANAGEMENT 
7.0 
Inclusion and Exclusion Criteria* 
7.1 
Eligibility Criteria:  
1. Inclusion Criteria 
1. Patients undergoing laparoscopic inguinal hernia repair.  
2. Ages 12 months to 8 years of age 

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3.  American Society of Anesthesiologists Physical Status Classification ASA 
1 or 2 
1. ASA 1- A normal, healthy patient 
2. ASA 2- A patient with mild systemic disease  
4. Elective with appropriate NPO status 
5. English speakers 
 
2. Exclusion Criteria 
 
1. Patients with current gastroesophageal reflux 
 
2. Obesity (CDC >= 95th %ile) 
 
3. Contraindications to study protocol medications 
 
 
7.2 
Equitable Selection:  Inclusion/exclusion criteria should be both fair and 
appropriate to the research question. If the study involves inclusion/exclusion 
criteria based on demographic characteristics such as sex, race/ethnicity, 
language, provide rationale for the criteria. For example, if excluding non-English 
speaking participants, provide rationale for why it is not possible to include non-
English speaking participants. 
Due to the limited sample size of patients enrolled, there is little to no anticipation of 
enrolling a non-English speaking patient. If a non-English speaking patient arises, the 
proper modifications will be put in place to present patient with translated consent 
forms and protocol, if need be. 
 
7.3 
Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☒ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☐ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity         

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☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
 
 
 
8.0 
Local Number of Participants 
8.1 
Indicate the total number of participants or charts to be enrolled 
locally as well as the accrual goal. If the study includes multiple groups or 
cohorts, be sure to describe the number of participants required for each 
cohort. If one of the groups includes a chart review, each chart is 
considered a participant and needs to be reflected in the numbers below.  
 
Group 1 
Group 2 
(if applicable) 
Totals 
Enrollment Goal: 
Number of participants to be enrolled = the 
number of participants to be consented or to 
be screened for chart reviews. 
25* 
25* 
50* 
*The total enrollment goal will remain 50 patients, but an additional 20 
patients will be enrolled to accommodate screening failures and 
withdrawals.  
 
9.0 
Identification and Recruitment of Potential Participants* 
9.1 
Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☒ Chart reviews  
 
☐ By their treating physician who will then provide the study team’s contact 
information to the potential participant/family 
☐ By their treating physician who will obtain patient/family permission to share 
contact information with the study team 
☐ Self-refer in response to IRB approved advertisements or websites  
☐ Through Cerner or other CM sources (e.g. databases, billing records, 
pathology reports, admission logs, etc.) May involve access of records by 
individuals not involved in the patient’s care. 
☐ List of candidates provided through the Data Report Request Form  

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☐ Registry of individuals interested in research opportunities   
☐ Past participant list 
☐ Participants will roll-over from another research study: Study # 
☒ Other: By treating provider, such as anesthesiologist or APRN, who is also a 
study team member, and who will discuss study with parent(s) and obtain 
informed consent (parental permission). 
 
9.2 
Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve 
access to Protected Health Information (PHI) prior to obtaining 
HIPAA Authorization? 
☐ Yes 
 
☒ No 
• If yes, a “Partial Waiver of HIPAA Authorization” is required.  Be sure to 
make this selection in the “HIPAA & Confidentiality” section below and 
complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
9.3 
Recruitment of Potential Participants:   
Parents of eligible patients presenting for laparoscopic inguinal 
hernia repair and being treated by a member of the study team, 
will be presented with information about the study prior to 
beginning anesthesia when completing the preoperative 
evaluation. Electronic medical records will be accessed to deem 
patients eligible. Parents will be given time to ask questions and 
consider whether to enroll their child in this study.  
 
10.0 Surveys and Psychometric Testing: 
• 
N/A 
11.0 Additional Study Activities 
• Additional study activities will include secondary data use – 
recording data from the medical record after the procedure is 
complete. 
11.1 
Blood and Other Specimen Collection: 

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1. N/A- no blood or other specimens will be collected for this 
study. 
 
 
12.0 Follow-up 
• N/A- no follow up is planned as part of this study. 
13.0 Genetic Analysis Information 
N/A- no genetic analysis is planned as part of this study. 
14.0 Sharing of Results with Participants 
14.1 
There are no plans to share results of the study with the 
participants, as their procedures will be complete before data is analyzed 
and results are available. 
 
15.0 Risks to Participants* 
15.1 
 
• This study involves no greater than minimal risk to 
participants, as the risks are similar to those that patients 
would encounter undergoing general anesthesia for a 
procedure.  Both LMA and ETT are commonly used standard 
anesthesia practices for various procedures.  
• There is also minimal risk to privacy associated with the chart 
review aspect of this study.  All data will be stored securely on 
the CMH network and in REDCap.  Only IRB-approved study 
team members will have access to the data. 
15.2 
This study involves no greater than minimal risk. 
15.3 
N/A 
15.4 
N/A 
15.5 
N/A 
 
16.0 Potential Benefits* 
16.1 
Potential benefits include: 
Potentially decreased time in operating room for LMA 
group. Potential benefit of avoiding ETT and possible 
decreased risk of respiratory complications. Possible 

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decrease in laryngospasm, bronchospasm, and 
postoperative respiratory complications. 
 
17.0 Investigator Assessment of Risk/Benefits Ratio*  
17.1 
Please provide an assessment of risk and benefits in the table below.  
Note, the IRB makes the final determination based upon responses in the two 
preceding sections. 
 
Select as applicable: 
Pediatric Risk Category: 
☒ 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual participants. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual participants, 
but 
likely to yield generalizable knowledge about the 
participant's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
☐ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
 
18.0 Payment, Reimbursement and Tangible Property provided to 
participants*  
Is payment, reimbursement, or tangible property part of the study?  
☐  Yes                 ☒  No (If No, delete the following subsections) 
 
19.0 Compensation for Research-Related Injury 
19.1 
This study is internally funded, involves no more than minimal risk 
and there is no planned compensation available in the event of research 
related injury. 
 

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20.0 Economic Burden to Participants 
20.1 
There are no costs to patients directly related to participation in 
this study.  Patients or their insurance will be billed for anesthesia 
received for their procedure whether enrolled in this study or not.  
 
21.0  Parental Permission and Adult Consent Process* 
 
21.1 
Indicate below all methods of Permission/Consent that will be used in 
this study.   
• If the study includes multiple study groups, be sure to indicate which 
method is being used with each group. 
• If requesting a Waiver of Documentation, a complete Waiver, or an 
Alteration, complete the required addendum at the end of  this 
document.   
 
Written Informed Permission/Consent 
☒ Written informed permission of parent/LAR for pediatric participants 
 
Study group(s) to which this method applies: Parent/LAR of participant 
☐ Written informed consent of adult participants 
 
Study group(s) to which this method applies: 
☐ Written informed consent of participants turning 18 
This includes the continued access to and use of their PHI by the study team. 
 
Study group(s) to which this method applies: 
 
Waiver or Alteration of Permission/Consent 
Parent/LAR permission/adult consent will NOT be obtained, or an alteration to an element(s) of 
consent. 
Must complete Addendum B: Waiver of Permission/Assent/Consent 
 
☐ Waiver/Alteration of permission of parent/LAR for pediatric participants 
 
Study group(s) to which this method applies: 
☐ Waiver/Alteration of consent of adult participants 
 
Study group(s) to which this method applies: 

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☒ Waiver/Alteration of consent of participants turning 18 
 
Study group(s) to which this method applies: 
 
 
21.2  Permission/Consent/Consent at 18 Discussion: If selected options for 
“Written” or “Waiver of Documentation” above, describe below how the 
informed permission/consent discussion will be conducted. Describe: 
• Where and when the discussion will take place.  The informed permission 
discussion will take place at CMH on the day of surgery.  A study team 
member, likely an Anesthesia APRN, will meet with the family prior to the 
child starting anesthesia, and will discuss the study with the parents. 
• To reduce coercion and undue influence, parents will be informed that 
their decision whether to participate in this study will not impact their 
child’s care at CMH.  If they choose not to participate, their child will 
receive standard care general anesthesia for their hernia repair. 
• eConsent will be used as an option for obtaining consent, which could 
reduce the possibility of clerical errors on consent forms while also 
helping to provide access to consent records between study teams in 
both Surgery and Anesthesia departments involved in this study  
• Study staff will try to meet with parents early enough before the 
procedure to allow time for parents to ask questions and consider 
enrollment decisions before needing to proceed with anesthesia and 
surgery procedures. 
• Study staff will ensure that parents understand what the study involves 
by incorporating techniques such as the teach-back method (asking 
parents to explain their understanding of the study before signing the 
consent form). 
• N/A- telephone permission/consent will not be used. 
 
21.3  Documentation of Permission/Consent/Consent at 18:  If selected 
“Written” options above, explain how informed permission will be documented.  
Describe: 
• Informed permission will be documented in the medical record according 
to CM Research Policy “10.04 Obtaining Permission/ Assent/ Consent” 
and “Research Documentation in the Electronic Health Record.” 
 
21.4  Identification of participants turning 18:  We are requesting a Waiver of 
Consent at 18 (see Addendum B).  This study will only enroll patients up to age 8.  
We do not anticipate that this study will continue for 10 years or more, until the 
time the oldest potential participants could turn 18.  Although the study will be 
closed by then, we are requesting a Waiver of Consent at age 18 to be able to 

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continue to retain data from this study in our Department of Surgery Data 
Repository (DSDR) after participants turn 18. 
 
22.0 Assent of Pediatric Participants 
 
22.1 
Select the option(s) that apply to the study: 
 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of 
ability to assent. 
Study group(s) to which this method applies: Participants aged 7 and 
above/deemed able and willing to understand in order to assent 
 
☒ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☒  The capability of the participants (considering the ages, maturity, physical 
and/or psychological state) is so limited that they cannot reasonably be 
consulted. 
☐  The intervention or procedure involved in the research holds out a prospect 
of direct benefit that is important to the health or well-being of the 
participants and is available only in the context of the research. 
Study group(s) to which this method applies: Participants under the age of 
7/deemed unable to understand in order to assent.   
 
☐ Obtaining assent of pediatric participants is NOT PRACTICLE given the 
context of this study (e.g., minimal risk, no direct contact with participants). 
Must complete Addendum B: Waiver/Alteration of 
Permission/Assent/Consent 
 
☐ 
 
22.2  Assessment of Ability to Assent:  The study team member conducting the 
consent discussion will also discuss the study with patients age 7 or older and 
will check their understanding of the study.   
 
22.3  Assent Discussion: If seeking assent from pediatric participants, explain 
how the assent discussion will be conducted. Describe: 
• The assent discussion will take place in conjunction with the informed 
consent discussion with parents prior to surgery. 
• Study team members will inform and reassure patients that they can 
decide not to participate in the study, and this decision will be respected. 
• Patients will be given the opportunity to ask any questions they might 
have, in addition to any other questions asked by parents. 

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• Study team members will verify understanding using techniques such as 
“teach back.” 
 
22.4  Documentation of Assent or Inability to Assent:  If seeking assent from 
pediatric participants, explain how assent, or a determination of inability to 
assent, will be documented.  Describe: 
• CM Research Policy “10.04 Obtaining Permission/ Assent/ Consent” and 
“Research Documentation in the Electronic Health Record” will be 
followed. 
• E-Consent will be used to document assent. 
 
23.0 HIPAA and Confidentiality 
HIPAA regulations apply to this study if the data used or accessed relates to: 
• The past, present or future physical or mental health or condition of an 
individual; 
• The provision of health care to an individual; OR 
• The payment for the provision of health care, AND 
identifies the individual or for which there is a reasonable basis to believe it can 
be used to identify the individual. 
 
23.1 
HIPAA Authorization  
Select all applicable methods of HIPAA Authorization that apply to this 
study.   
☒  Full Written HIPAA Authorization will be obtained (within the p/a/c form or 
standalone form) 
 
☒ Partial Waiver of HIPAA Authorization (e.g. waiver for recruitment and pre-
screening purposes only) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
☐ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g. signature will not be obtained) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
a) Describe which proposed elements to be altered. 
 
☐ Waiver of HIPAA Authorization (authorization will NOT be obtained) 
 
☒ If Other, explain:  We are requesting a Waiver of HIPAA Authorization at age 
18 to allow data to continue to be retained in the DSDR without reconsenting 
former participants who have since turned 18.  See Addendum E. 

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23.2 Specify the PHI for which accessing (“viewing”) or recording 
(“writing down”) is necessary for the purpose of this research: 
To minimize risks, only the minimum necessary identifiable data should be 
accessed and/or recorded.  
 
1. Name/Initials 
☐ Accessed only 
☒ Recorded 
2. All elements of date (except year) directly 
related to an individual (e.g. date of birth, 
admission date, discharge date, date of 
death) 
☐ Accessed only 
☒ Recorded 
3. Medical record number 
☐ Accessed only 
☒ Recorded 
4. Account number 
☐ Accessed only 
☒ Recorded 
5. Health plan identification number 
☐ Accessed only 
☐ Recorded 
6. Social Security Number 
☐ Accessed only 
☐ Recorded 
7. Device identifiers and serial number 
☐ Accessed only 
☐ Recorded 
8. Certificate/License number 
☐ Accessed only 
☐ Recorded 
9. Telephone number 
☐ Accessed only 
☐ Recorded 
10. Fax number 
☐ Accessed only 
☐ Recorded 
11. Email addresses 
☐ Accessed only 
☐ Recorded 
12. Web addresses (URLs); Internet IP addresses 
☐ Accessed only 
☐ Recorded 
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐ Accessed only 
☐ Recorded 
14. Full face photographic images and any 
comparable images 
☐ Accessed only 
☐ Recorded 
15. Biometric identifiers, including finger and 
voice print 
☐ Accessed only 
☐ Recorded 
16. Vehicle identifiers and serial numbers, 
including license plate number 
☐ Accessed only 
☐ Recorded 
17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g. student or employee ID number) 
☐ Accessed only 
☐ Recorded 
18. Elements of date, including year, for persons 
90 years or older 
☐ Accessed only 
☐ Recorded 
19. Other: 
☐ Accessed only 
☐ Recorded 
 
23.3 
 

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The confidentiality of data will be protected by recording data in REDCap 
securely on the CMH network servers, by allowing access only to study 
personnel approved by the IRB to work on the study, and by storing 
Master List identifiers (Name and MRN) on a separate form than the 
study data. 
 
 
23.4 
 
No Certificate of Confidentiality will be issued for this study. 
 
24.0 Provisions to Protect the Privacy Interests of Participants* 
24.1 
 
The Permission/Assent/Consent discussion will take place in a private room with 
only the parent(s) and study team members present, to ensure privacy during 
the P/A/C process. 
24.2 
Study team members conducting the Permission/Assent/Consent 
discussion with families will be trained to ensure parents that participation in the 
study is completely voluntary and not required for their treatment, and to 
encourage parents to ask questions about the study to help them feel at ease. 
24.3 
The study team members conducting P/A/C discussions will have access 
to information about these patients, as they will be encountering them as part of 
the standard clinical treatment planned for these patients.  They will ensure 
privacy of this information as required for any other clinical information about 
patients. 
 
25.0 Withdrawal of Participants* 
25.1 
We do not anticipate any circumstances under which participants 
would be withdrawn from the study without their consent, however the 
procedure may change after consenting, either due to surgeon 
preference of unforeseen circumstances, that would therefore exclude 
your child from research. 
25.2 
If a parent chooses to withdraw their child from the study, any 
data collected about the child will be retained in the study unless the 
parent requests to have the data excluded from the study. 
 
 
DATA MANAGEMENT 

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26.0 Data Collection* 
26.1 
Data collected during the study will include data about the hernia 
repair procedure outcome and about the encounter in general (e.g., 
length of stay, comorbidities impacting length of stay). 
26.2 
Data will be obtained from the medical record after the hernia 
repair procedure is completed. 
26.3 
N/A 
☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐
☐☐☐☐☐☐☐☐☐☐☐ 
 
27.0 Adverse Events and Unanticipated Problems* 
27.1 
Monitoring:   
27.2 
There are no Adverse Events or Unanticipated Problems associated with 
this study, as the LMA and ETT techniques being evaluated are already used in 
current standard care.  As when these techniques are used in current standard 
care, the Anesthesia team will closely monitor patients during the procedure and 
will modify anesthesia if clinically warranted. 
 
27.3 
Reporting:  We will follow Policy 5.11 Reportable Events of the CM 
Research Program Policies and Procedures in regards to reporting adverse 
events and other unanticipated problems to the CM IRB.  
 
28.0 Statistical Analysis* 
28.1 
The data analysis will be a simple calculation of demographics and 
incidence of complications. Comparison between groups will be 
completed using chi square for categorical variables and t-test for 
continuous variables. Statistical significance will be set at p-value <0.05 
We determined the targeted sample size of 50 patients using a power 
calculation using the following parameters: 90% power, 2.5% Type I error 
rate, non-inferiority limit of 5% point of SP02, no difference between 
treatments, and standard deviations of 1, 2, 5, and 10. 
 
29.0 Data and Specimen Management* 
29.1 
Data Management:  Describe how data will be handled, including: 
Data will be collected by reviewing the participant’s medical record 
after the circumcision procedure is complete.  Data will be recorded 
in REDCap, securely stored on the CMH servers, and only accessible to 
IRB-approved study team members.  Data will be rolled into the 

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Department of Surgery Data Repository (DSDR, IRB#18020079) at the 
time of data collection, and will remain stored in the DSDR under the 
approved provisions of the repository for potential use in future 
research studies. 
29.2 
Specimen Management: Describe how specimens will be handled, 
including: 
1. N/A 
 
29.3 
Biosafety Information 
Will this study involve handling, transporting, or shipping any 
potentially hazardous biological material at/from a Children’s 
Mercy location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 
☒ No 
Will this study involve processing any potentially hazardous 
biological material at a Children’s Mercy location (e.g., blood, 
stool, saliva, tissue)? 
☐ Yes 
☒ No 
If processing potentially hazardous biological materials, where will 
this work be conducted? 
☐ Pediatric Clinical Research Unit (PCRU) 
☐ Children's Mercy Research Institute Biorepository (CRIB) 
☐ Children’s Mercy Research Institute labs (mySafety 
ID#:__________) 
☐ Other location 
If “Other location,” identify the location and mySafety ID# of the 
corresponding IBC protocol: 
Location: ____________________ 

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mySafety ID#: ___________________________  
 
30.0 Storing of Data and/or Banking of Specimens for Future Research 
30.1 
If this study involves storing of data or banking of leftover 
specimens for future research, indicate how the use will be managed: 
☒  Contributing data and/or leftover specimens to an existing CM 
repository protocol (myIRB#18020079, Department of Surgery Data 
Repository (DSDR)) 
☐  Contributing data and/or leftover specimens to an existing non-CM 
repository (Institution/Repository Name: _________________________) 
☐  Not contributing to an existing repository for the management of 
data/specimens for future research use.   
☐  Other: 
 
31.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
This section is required when research involves more than Minimal Risk to 
participants. 
31.1 
In addition to the Principal Investigator, which individual or group 
will be responsible for monitoring the data and safety for this study? 
 
☐ Sponsor or Sponsor Designee (including the Sponsor CRO) 
☐ Data and Safety Monitoring Board (DSMB) or Data Safety Monitoring 
Committee (DSMC)  
☐ Independent Monitor (s) 
☐ Internal Committee at CM 
☒ Other: ____N/A________ 
 
31.2 
Data Safety Monitoring Plan: If a DSMB charter or other external 
monitoring plan is available, upload in the myIRB application, Other 
Attachments section. If such a charter/plan is not available, describe: 
1. There are no plans for a DSMB for this study. 
 
STUDY MANAGEMENT 
32.0 Setting & Locations* 

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32.1 
Describe the sites or locations where the research will be 
conducted. 
1. Participants will be recruited when present for hernia 
repair procedures at CMH or CMK.  Data collection and 
study coordination will also take place in the offices of 
the General Surgery department at CMH. 
 
33.0 Multi-Site Research- N/A 
Choose ALL relationship types that apply:  
☐    Multi-Site Research: Multiple sites will be engaged in this human research 
project. Sites will use the same protocol to conduct the same human research 
activities (except for minor variations due to local context considerations).   
☐    Collaborative Research: Multiple sites will be engaged in this human 
research project. Sites will not be performing the same research activities. The 
Site submission will specify the specific research activities each site will perform.  
REQUIRED: Enter summary of site-specific activities that differ from the 
overall protocol: Click or tap here to enter text.  
☐    Student(s):  Student(s) will help with this project and will be engaging their 
home institution.  
☐    Visiting Resident(s) / Visiting Fellow(s):  Visiting Resident(s) / Visiting 
Fellow(s) will help with this project and will be engaging their home institution.  
 
Is Children’s Mercy (CM) acting as the single IRB of Record (sIRB)? 
☐    No, each site is getting their own IRB approval.  
☐    Yes, some or all sites will rely on the CM as the sIRB.  
• Reliance is required for non-Exempt NIH or other Federally 
Funded research where: 
o The institution's employees or agents intervene or 
interact with human subjects for research purposes;     
o The institution's employees or agents obtain 
individually identifiable private information or 
identifiable biospecimens about human subjects for 
research purposes; or     
o The institution receives a direct HHS award to conduct 
human subjects research, even where all activities 
involving human subjects are carried out by a 
subcontractor or collaborator.  

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If CM is sIRB for another site, complete the chart for that site(s) (Add a new row 
for each site relying on the CM IRB, delete chart if not acting as sIRB): 
Site Name 
Enrollment Goal for 
Site(s) 
Choose One 
Relying on CM IRB?  
Insert Site Name 
☐  Site Enrollment 
Goal: Insert # 
 
☐  Site will not 
enroll  
☐  External Site will rely on the CM IRB as 
the IRB of Record using a reliance 
agreement. () 
☐  Not Applicable. Site will not interact or 
intervene with human participants or their 
identifiable data / identifiable biospecimens. 
Site is also not a primary NIH or federal 
grant recipient.   
 
 
 
 
 
34.0 International Research 
34.1 
N/A- no international research is part of this study. 
 
 

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Addendum B: Waiver/Alteration of Permission/Assent/Consent 
 
NOTE: If requesting a waiver of parental/LAR permission because parental permission is 
not a reasonable requirement to protect the participants [e.g. research on neglected or 
abused children], contact irb@cmh.edu to discuss additional regulatory requirements. 
 
Regulatory Criteria: To qualify for a waiver or alteration of parental permission or adult 
consent, ALL of the following must apply.  Explain how the study meets each of the 
regulatory criteria below.   
 
Criteria 
Explain how the study meets the criteria 
The research involves no more 
than minimal risk to the 
participants 
We are requesting a Waiver of Consent at age 18 to allow 
data to continue to be retained in the DSDR without 
reconsenting participants when they turn 18.  This study 
involves no more than minimal risk in comparing two 
standard anesthesia methods and collecting data from 
patients’ medical records.  Continuing to keep the data in 
the repository after patients turn 18 does not increase the 
risk of the study, as parents and patients will have been 
informed at the time of Permission/Assent that the data 
being contributed to the DSDR for use in future studies. 
The research could not 
practicably be carried out 
without the requested 
waiver/alteration (i.e., explain 
why the study could not be 
done if 
permission/assent/consent 
were required) 
Reconsenting patients at age 18 would not be practicable 
for several reasons.  This study only enrolls patients up to 
age 8.  Most of these patients will not have ongoing 
treatment or contact with CMH for 10 years or more until 
they potentially turn 18, and many would likely be lost to 
contact.  Retaining all of the data from the initial data set 
will be necessary to ensure usefulness of this data for any 
future studies. 
If the research involves using 
identifiable private 
information or identifiable 
biospecimens, the research 
could not practicably be 
carried out without using such 
information or biospecimens 
in an identifiable format 
Just as identifiers are necessary in the initial study to verify 
data accuracy and compare time points and intervals during 
treatment, these identifiers need to be retained in the data 
repository to allow this data to be useful in future studies. 
The waiver/alteration will not 
adversely affect the rights and 
welfare of the participants 
A Waiver of Consent at age 18 does not adversely affect the 
rights or welfare of participants, as their parents will have 
already given their permission to include this data in the 
repository, where it will have already been stored for 10 
years or more before participants turn 18. 

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Whenever appropriate, the 
participants or legally 
authorized representatives 
will be provided with 
additional pertinent 
information after participation 
This is not applicable to a Waiver of Consent at age 18.  If 
any pertinent information for parents or participants were 
to be discovered, parents and/or participants would be 
informed no matter the age of participants at that time.  It is 
unlikely that any pertinent information would be discovered 
though after patients turn 18, as the study will have been 
concluded for several years by that time. 
 
Proposed Alteration (if applicable):  
Select which required elements of permission are to be omitted. 
☐ A statement that the study involves research, an explanation of the purposes of 
the research and the expected duration of the participant's participation, a 
description of the procedures to be followed, and identification of any 
procedures that are experimental; 
 
☐ A description of any reasonably foreseeable risks or discomforts to the 
participant; 
 
☐ A description of any benefits to the participant or to others that may reasonably 
be expected from the research; 
 
☐ A disclosure of appropriate alternative procedures or courses of treatment, if any, 
that might be advantageous to the participant; 
 
☐ A statement describing the extent, if any, to which confidentiality of records 
identifying the participant will be maintained; 
 
☐  For research involving more than minimal risk, an explanation as to whether any 
compensation and an explanation as to whether any medical treatments are 
available if injury occurs and, if so, what they consist of, or where further 
information may be obtained; 
 
☐  An explanation of whom to contact for answers to pertinent questions about the 
research and research participants' rights, and whom to contact in the event of a 
research-related injury to the participant; 
 
☐  A statement that participation is voluntary, refusal to participate will involve no 
penalty or loss of benefits to which the participant is otherwise entitled, and the 
participant may discontinue participation at any time without penalty or loss of 
benefits to which the participant is otherwise entitled; and 
 
☐  One of the following statements about any research that involves the collection 
of identifiable private information or identifiable biospecimens: 

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☐  A statement that identifiers might be removed from the identifiable private 
information or identifiable biospecimens and that, after such removal, the 
information or biospecimens could be used for future research studies or 
distributed to another investigator for future research studies without 
additional informed consent from the participant or the legally authorized 
representative, if this might be a possibility; or 
 
☐  A statement that the participant's information or biospecimens collected as 
part of the research, even if identifiers are removed, will not be used or 
distributed for future research studies. 
 
Provide the rationale for omitting the item(s) selected: 
 
 

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Addendum E: Waiver/Alteration of HIPAA Authorization** 
** For 18 + reauthorization 
 
Regulatory Criteria: To qualify for a waiver/alteration of HIPAA Authorization, ALL of the 
following must apply to a study. Explain how the study meets each of the regulatory 
criteria below.   
 
 
 
 
Criteria 
Explain how the study meets the 
criteria 
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
a. Plan to protect PHI from 
improper use and disclosure: 
b. Plan to destroy PHI at the 
earliest opportunity, unless 
there is a health or research 
justification for retaining the 
PHI: 
c. Assurance that PHI will not be 
reused or disclosed to any 
other person or entity: 
 
We are requesting a Waiver of 
HIPAA Authorization at age 18 to 
be able to continue to retain PHI. 
PHI will be retained in the 
repository to allow this data to be 
useful for potential future 
research studies involving LMA or 
hernia repair.  PHI will only be 
disclosed if a future study has IRB 
approval to request the data from 
the DSDR and meets any other 
requirements of the DSDR for 
data use. 
The research cannot practicably 
be conducted without the 
waiver/alteration, i.e. explain why 
a signature for HIPAA 
Authorization cannot be obtained. 
Requiring reauthorization of 
HIPAA when patients turn 18 
would be impracticable.  This 
study only enrolls patients up to 
age 8.  Most of these patients will 
not have ongoing treatment or 
contact with CMH for 10 years or 
more until they potentially turn 
18, and many would likely be lost 
to contact.   
The research cannot practicably 
be conducted without access to 
and use of the PHI, i.e. explain 
why access to PHI is needed for 
this study. 
Retaining all the PHI from the 
initial data set will be necessary to 
ensure usefulness of this data for 
any future studies. 

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Addendum E: Waiver/Alteration of HIPAA Authorization** 
** For Pre-Screening 
 
Regulatory Criteria: To qualify for a waiver/alteration of HIPAA Authorization, ALL of the 
following must apply to a study. Explain how the study meets each of the regulatory 
criteria below.   
 
 
Criteria 
Explain how the study meets the 
criteria 
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
d. Plan to protect PHI from 
improper use and disclosure: 
e. Plan to destroy PHI at the 
earliest opportunity, unless 
there is a health or research 
justification for retaining the 
PHI: 
f. Assurance that PHI will not be 
reused or disclosed to any 
other person or entity: 
 
PHI will only be available to and 
accessed by IRB approved study 
staff. 
 
Health or research justification for 
keeping PHI:  
PHI will be reused, disclosed, or 
transferred outside of the study 
team: Contributing data to an 
existing CM repository protocol 
(myIRB#18020079)  
 
PHI will only be available to and 
accessed by IRB approved study 
staff. 
The research cannot practicably 
be conducted without the 
waiver/alteration, i.e. explain why 
a signature for HIPAA 
Authorization cannot be obtained. 
Partial Waiver of HIPAA 
Authorization for Recruitment 
only: It is necessary to access PHI 
prior to speaking with patients 
and families, to determine if 
patients are eligible for the study.   
It is not practical to obtain written 
HIPAA authorization for any 
patient that may meet the 
inclusion criteria as the study 
team will not know who may be 
eligible for screening.  
The research cannot practicably 
be conducted without access to 
and use of the PHI, i.e. explain 
why access to PHI is needed for 
this study. 
PHI is necessary to ascertain 
whether the participant meets the 
inclusion criteria, and all collected 
data is needed to meet the study 
aims.