Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit
Phase: NA
Conditions: Anesthetic Gas Consumption and Cost-Effectiveness
Sponsor: University of California, Irvine

SANTA BARBARA
SANTA CRUZ
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BERKELEY
DAVI S
IRVI NE
LOS ANGELES
RIVERSIDE
SAN DIEGO
SAN FRANCISCO
•
•
•
•
•
•
UNIVERSITY OF CALIFORNIA, IRVINE 
 
 
 
 
 
Study Protocol 
Title: Comparison of Different Ventilator and Vaporizer Technologies to Study Economic and 
Environmental Implications 
NCT#: 04851314 
Date: 10-05-2018 
 
 
 
R. Ryan Field, MD 
Clinical Director of Neuroanesthesiology 
Neuroanesthesiology Rotation Director 
Clinical Competency Committee 
Section Editor Engineering and Tech CSA 
Associate Professor 
Department of Anesthesiology 
Department of Neurosurgery 
Department of Neurocritical Care 
UC Irvine Health 
 

  
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PROTOCOL NARRATIVE FOR EXPEDITED OR FULL COMMITTEE RESEARCH 
 
University of California, Irvine 
Institutional Review Board 
Version: April 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HS#: 2014-1248 
For IRB Office Use Only 
 
Lead Researcher Name: Robert Ryan Field, MD 
Study Title:   Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a 
Comparison to Established Anesthesia Delivery Unit 
 
 
 
NON-TECHNICAL SUMMARY   
 
 
Provide a non-technical summary of the proposed research project that can be understood by 
IRB members with varied research backgrounds, including non-scientists and community 
members.  The summary should include a brief statement of the purpose of the research and 
related theory/data supporting the intent of the study as well as a brief description of the 
procedure(s) involving human subjects.  This summary should not exceed ½ page.  
 
 
During general surgery, patients receive a series of standard medications to induce and 
maintain anesthesia and pain control. The anesthesia machines help deliver these inhaled 
anesthetics, while at the same time breathing for the patients. Most anesthesia machines have 
large volume breathing circuits that needlessly waste inhaled gas anesthetics. An FDA-
approved FLOW-i C20 anesthesia machine uses a low volume system without large reservoirs.  
 
The primary aim of this research is to evaluate the cost-effectiveness of the MAQUET FLOW-i 
C20 machine. Reducing the circuit volume can have many benefits. Most anesthesia machines 
require higher fresh gas flows and deliver fresh gas flow throughout the entire respiratory cycle. 
The Maquet machine requires significantly less fresh gas flow and only delivers fresh gas flow 
during inspiration. The purpose of this study is to compare the MAQUET FLOW-i machine 
to high volume anesthetic machines.  
 
SECTION 1: PURPOSE AND BACKGROUND OF THE RESEARCH  
 
 
1. Describe the purpose of the research project and state the overall objectives, specific 
aims, hypotheses (or research question) and scientific or scholarly rationale for performing 
the study.   
2. Provide the relevant background information on the aims/hypotheses (or research 
question) to be tested and the procedures/products/techniques under investigation.   
3. Include a description of the primary outcome variable(s), secondary outcome variables, 
and predictors and/or comparison groups as appropriate for the stated study objectives.     
4. Include a critical evaluation of existing knowledge, and specifically identify the information 
gaps that the project intends to address.   
5. Describe previous research with animals and/or humans that provides a basis for the 
proposed research.  Include references/citations, as applicable. 
This section should not exceed 4 pages. 
 
The purpose of this study is to test whether or not the use of a low volume ventilator in an 
anesthesia machine reduces anesthetic costs significantly as compared to other high volume 
machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine 

 
 
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during routine elective general surgery in patients with ASA ratings of 1-2 under general 
anesthesia receiving standard care. 
 
 
General anesthesia based on the administration of inhaled anesthetics is common practice. The 
clinical use of sevoflurane is standard of care in the operating room. There are today a variety of 
anesthetic devices introducing the gas in somewhat different manners. The technical solution has 
an impact on entire gas consumption. Techniques providing safe and effective anesthesia but 
with a minimum of waste is sought in order to decrease direct drug related costs. 
 
1. Primary study variable: amount of gas vaporized anesthetic per minute anesthesia. 
2. Secondary study variables:  
a. Time to reach Aldrete > 8 
b. Time to extubation from weaning 
c.  Maquet firmware-based volatile anesthetic consumption data 
 
Sevoflurane an inhaled halogenated anesthetic has physiochemical properties promoting its use 
in low flow anesthesia. 
 
Low blood gas solubility promotes in theory the use of the third generation inhaled anesthetics for 
use during general anesthesia with low fresh gas flow. The benefits of low blood and tissue 
solubility during low and minimal flow are not yet studied. 
 
Reducing the fresh gas circuit volume has many benefits; it reduces the risk for unnecessary 
workplace contamination, environmental pollution and it is cost-effective. Intravenous (IV) 
propofol based anesthesia has become increasingly popular. The low volume inhaled anesthesia 
technique would assumingly also become cost-effective rivalling generic low price propofol. The 
simplicity to start and continuously monitor anesthetic depth which is difficult with IV anesthetics 
should also be recognized.  
 
The breathing circle should attain an adequate gas mixture of inhaled; oxygen and inhaled agent 
as well as the absence of carbon dioxide. The anesthetic machine provides the fresh gas 
entering the breathing circle. The delivery of fresh gas differs between machines. The feeding of 
fresh gas and subsequent anesthetic vapor in to the breathing circle differs between devices. The 
amount of vapor introduced to the breathing circle has a major impact on the gas kinetics and 
subsequent need for total gas delivered.  
 
Avramov MN, Griffin JD, White PF. The effect of fresh gas flow and anesthetic technique on the ability to control acute 
hemodynamic responses during surgery. Anesth Analg. 1998; 87: 666-70. 
 
Choi SU, Shin HW, Jung HI, Park JY, Yoon SZ, Lee YS, Kim WY, Chang SH. Control of the haemodynamic response 
to surgical stimuli in semi-closed circuit or closed circuit anaesthesia using a multifunctional anaesthesia system. J Int 
Med Res. 2010; 38: 1637-44. 
 
 
 
 
SECTION 2: ROLES AND EXPERTISE OF THE STUDY TEAM  
 
 
List all study team members below.  
 
1. Identify each member’s position (e.g., Associate Professor, graduate or undergraduate 

 
 
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student) and department, and describe his or her qualifications, level of training and 
expertise. Include information about relevant licenses/medical privileges, as applicable. 
2. Describe each team member’s specific role and responsibility on the study.   
3. Faculty Sponsors - list as Co-Researchers and describe their role on the project; include 
oversight responsibilities for the research study.  
4. Explain who will have access to subject identifiable data. 
5. Indicate who will be involved in recruitment, informed consent process, research 
procedures/interventions, and analysis of data.  
 
 
Lead Researcher:   
 
Robert Ryan Field, MD is an Assistant Clinical Professor of the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center. Dr. Field is a practicing anesthesiologist 
that directs neuroanesthesiology services, and co-directs the CA3 curriculum. He is published 
in ICU delirium and ICU Sedation, has worked in multiple research laboratories ranging from 
work as a design engineer to FDA/TÜV documentation compliance officer for medical devices 
and processes.  Duties include: access to identifiable data, recruitment of patients, consenting 
of patients, and involvement in research, procedures, and data collection. 
 
Co-Researchers: 
 
 
 
 
 
Cameron Ricks, MD is an Associate Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
 
Coral Sun, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Corey Nelson, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Darren R. Raphael, MD, MBA is a Clinical Instructor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
 
Dmitry Portnoy, MD is an Associate Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Joseph B. Rinehart, MD is an Associate Clinical Professor in the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 

 
 
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Kimberly Gimenez, MD is a Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
 
Leslie Garson, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
 
Navid Alem, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Richard Kelly, MD, MPH is an Assistant Clinical Professor in the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
 
Shalini Shah, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Shermeen B. Vakharia, MD, MBA is a Clinical Professor in the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Trung Vu, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center.  Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection. 
 
Kyle Ahn, MD is an Associate Clinical Professor in Regional Anesthesia & Acute Pain 
Medicine, Interim Director for the Residency Program, and Fellowship Program Director in the 
Department of Anesthesiology and Perioperative Care at UC Irvine Medical Center. Duties 
include: access to identifiable data, recruitment of patients, consenting of patients, involvement 
in research, procedures, data collection.  
 
 
Jane Ahn, MD is an Associate Clinical Professor and Director of Acute Pain and Regional 
Service in the Department of Anesthesiology and Perioperative Care at UC Irvine Medical 
Center. Duties include: access to identifiable data, recruitment of patients, consenting of 
patients, involvement in research, procedures, data collection.  
 
 
Ho Joon Choi, MD is a Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection  
 

 
 
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Anna Harris, MD is a Clinical Professor, Associate Program Director for the Residency 
Program and the Director of the Perioperative Clinic in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Suzanne Strom, MD is an Associate Clinical Professor and Director of the Residency Program 
in the Department of Anesthesiology and Perioperative Care at UC Irvine Medical Center. 
Duties include: access to identifiable data, recruitment of patients, consenting of patients, 
involvement in research, procedures, data collection.  
 
 
Waylan Wong, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
 
Gregory Yoshikawa, MD is an Assistant Clinical Professor in the Department of 
Anesthesiology and Perioperative Care at UC Irvine Medical Center. Duties include: access to 
identifiable data, recruitment of patients, consenting of patients, involvement in research, 
procedures, data collection.  
Financial Interest: No  
 
Howard Schwid, MD is a Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Ramin Rahimian, MD, MBA is an Assistant Clinical Professor in the Department of 
Anesthesiology and Perioperative Care at UC Irvine Medical Center. Duties include: access to 
identifiable data, recruitment of patients, consenting of patients, involvement in research, 
procedures, data collection.  
 
 
Ariana Nelson, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Chinsui Chou, MD is an Assistant Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Kyle Paredes, MD, MBA is an Assistant Clinical Professor in the Department of 
Anesthesiology and Perioperative Care at UC Irvine Medical Center. Duties include: access to 
identifiable data, recruitment of patients, consenting of patients, involvement in research, 
procedures, data collection.  
 
Aaron Przybysz, MD, PhD is an Assistant Clinical Professor in the Department of 
Anesthesiology and Perioperative Care at UC Irvine Medical Center. Duties include: access to 
identifiable data, recruitment of patients, consenting of patients, involvement in research, 

 
 
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procedures, data collection.  
 
Taizoon Dhoon, MD is an Assistant Clinical Professor in the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Yashar Eshraghi, MD is an Assistant Clinical Professor in the Department of Anesthesiology 
and Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
collection.  
 
Rakhi Dayal, MD is an Associate Clinical Professor in the Department of Anesthesiology and 
Perioperative Care at UC Irvine Medical Center. Duties include: access to identifiable data, 
recruitment of patients, consenting of patients, involvement in research, procedures, data 
 
 
 
Research Personnel: 
 
Paulette Mensah, BA is a clinical researcher in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Michael Ma, BS is a clinical researcher in the Department of Anesthesiology and Perioperative 
Care at UCIMC. Duties include: access to identifiable data, consenting of subjects to confirm 
willingness to participating in research; however, he will not discuss the specifics of 
administering anesthesia or finalize the consent process as only a qualified, licensed physician 
is able to do so; involvement in collection of data. 
 
Michael-David Calderon, BS, is a clinical researcher in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, he will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
David Avila, BS is a volunteer research intern in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, he will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
 
Yousif Arif is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, he will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Elika Salimi is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 

 
 
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licensed physician is able to do so; involvement in collection of data. 
 
Nagi Alazani is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, he will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Bianca Abramian is an undergraduate research student in the Department of Anesthesiology 
and Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Alexis Carmona is an undergraduate research student in the Department of Anesthesiology 
and Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Hailey Maxwell is a research volunteer in the Department of Anesthesiology and Perioperative 
Care at UCIMC. Duties include: access to identifiable data, consenting of subjects to confirm 
willingness to participating in research; however, she will not discuss the specifics of 
administering anesthesia or finalize the consent process as only a qualified, licensed physician 
is able to do so; involvement in collection of data. 
 
Nikhil Crain is a research volunteer in the Department of Anesthesiology and Perioperative 
Care at UCIMC. Duties include: access to identifiable data, consenting of subjects to confirm 
willingness to participating in research; however, she will not discuss the specifics of 
administering anesthesia or finalize the consent process as only a qualified, licensed physician 
is able to do so; involvement in collection of data. 
 
Frank Major is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Kendrick Bai is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Yuhan Li is an undergraduate research student in the Department of Anesthesiology and 
Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
Rita Khechumyan is an undergraduate research student in the Department of Anesthesiology 
and Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 

 
 
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licensed physician is able to do so; involvement in collection of data. 
 
Salama Sheren is an undergraduate research student in the Department of Anesthesiology 
and Perioperative Care at UCIMC. Duties include: access to identifiable data, consenting of 
subjects to confirm willingness to participating in research; however, she will not discuss the 
specifics of administering anesthesia or finalize the consent process as only a qualified, 
licensed physician is able to do so; involvement in collection of data. 
 
 
 
 
SECTION 3: RESEARCH METHODOLOGY/STUDY PROCEDURES 
 
A. Study Design and Procedures 
 
 
1. Provide a detailed chronological description of all study activities (e.g., pilot testing, 
screening, intervention/interaction/data collection, and follow-up) and procedures.  
a. Include an explanation of the study design (e.g., randomized placebo-controlled, cross-
over, cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification, 
randomization, and blinding scheme.  
b. Provide precise definitions of the study endpoints and criteria for evaluation; if the 
primary outcomes are derived from several measurements (i.e., composite variables) 
or if endpoints are based on composite variables, describe precisely how the 
composite variables are derived. 
c. Indicate how much time will be required of the subjects, per visit and in total for the 
study.  
d. Indicate the setting where each procedure will take place/be administered (e.g. via 
telephone, clinic setting, classroom, via email). Note: If any of the procedures will take 
place at off-campus locations (e.g., educational institutions, businesses, organizations, 
etc.) Letters of Permission are required.  
e. If a procedure will be completed more than once (e.g., multiple visits, pre and post 
survey), indicate how many times and the time span between administrations. 
2. For studies that involve routine (standard of care) medical procedures: 
Make clear whether procedures are being done for clinical reasons or for study purposes, 
including whether the procedures are being done more often because of the study. Use the 
following guidelines to determine the extent to which standard procedures and their 
associated risks need to be described in protocol:  
a. If the standard procedure is not explicitly required by the study protocol, the protocol 
need not describe that procedure or its risks.  
b. If the standard procedure is a main focus of the study (e.g., one or more arms of a 
randomized study is standard) or is explicitly required by the study protocol, the protocol 
must include a full description of the procedure and its risks.] 
3. It is strongly recommended that you include a table of visits, tests and procedures. Tables 
are easier to understand and may help to shorten long repeated paragraphs throughout the 
narrative. 
4. If study procedures include collecting photographs, or audio/video recording, specify 
whether any subject identifiable information will be collected and describe which identifiers 
will be collected, if any.  
5. Describe how the subject’s privacy will be protected during the research procedures. 
Note: This is not the same as confidentiality (see the Privacy and Confidentiality web 
page). 
6. Be sure to submit data collection instruments for review with your e-IRB Application 
(e.g., measures, questionnaires, interview questions, observational tool, etc.).   

 
 
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The study member will screen for potential subjects using the UCIMC surgical schedule. If a 
subject is deemed ineligible based on the inclusion and exclusion criteria after reviewing the 
medical history, his/her record will be discarded. No records will be retained from ineligible 
subjects. After discussing with the patient’s surgeon, study team member will initiate the 
informed consent process by approaching each eligible subject to explain the study and what it 
entails. The Lead Researcher will address all questions and concerns from the subject before 
asking the subject to sign the research consent form.   
 
The GE anesthesia machines currently owned by the operating room will be used to serve as the 
comparator to the Flow-i machine. The high volume anesthesia machines do not use a low 
volume system. Subjects will be randomized by recruitment day. On a given recruitment day, all 
consented subjects will receive anesthesia from one of two groups:  
 
(1) MAQUET FLOW-i device 
(2) GE anesthetic device  
 
 
Time points for both groups include: 
 
T0: Time of intubation, when volatile anesthetic are typically first delivered to the patient. We will 
use 15L/min fresh gas flow, while dictating tidal volumes of 6-8 mL/kg ideal body weight and a 
PEEP of 6 centimeters of water (cm H2O) in accordance with current best practices.  
  
 
T1: Time of incision, which typically represents the time of reaching steady state conditions of 
volatile anesthetic delivery. We will reduce fresh gas flow to 2 L/min in accordance with local 
practice and weigh the vaporizer at this point, allowing us to measure comparative anesthetic 
consumption during this wash-in time period (T0-T1). 
 
T2: Time of anesthetic weaning, typically the time when preparing for patient emergence begins 
by discontinuing the delivery of volatile anesthetics to the patient. The vaporizer will be re-
weighed at this point, allowing us to measure comparative anesthetic consumption at steady 
state maintenance of anesthetic depth (T1-T2) 
 
Logically, we will also be able to use T0-T2 in order to understand total comparative anesthetic 
consumption.  
 
Aside from the randomization to either Group 1 or Group 2, there will be no changes in the 
surgical or anesthetic procedure, including the medication or treatments given to the subjects as 
determined by the treating physician. All subjects will receive general anesthesia in accordance 
to local practice. 
 
For this study, the vaporizer(s) will be weighed on a tared scale before research procedures 
commence, after induction, and when the gas is shut off during weaning of anesthesia in 
preparation for extubation to calculate the amount consumed during this time (grams/minute).  In 
addition, the following variables will be recorded: 
 
 
Subject weight (kg) 
 
Tidal Volume (TV) 
 
Respiratory Rate (RR) 

 
 
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 
Positive end-expiratory pressure (PEEP) 
 
Fresh Gas Flow 
 
Volume % gas  
 
End Tidal (%) 
 
Time of extubation 
 
Time when Aldrete score > 8 
 
This is not a physician-blinded study being that the physical characteristics of the standard 
delivery units are distinguishable from the MAQUET FLOW-i machine. 
 
All MAC concentrations are standard of care: After the surgical procedure, patient will be 
assessed for time to reach Aldrete score greater than 8, level of pain and time to extubation.  
Their medical records will be reviewed to determine need for times and adverse events.  
Patients will not be contacted for study-related follow-up after they are discharged from 
recovery. 
 
No photographs or audio/video recording will be collected for this study. 
 
Subject’s Privacy: 
The study team member will screen for potential subjects using the UCIMC surgical schedule. 
If a subject is deemed ineligible based on the inclusion and exclusion criteria after reviewing 
the medical history, his/her record will be discarded. No records will be retained from ineligible 
subjects.  
 
Study team member will approach each eligible patient to explain the study and what it entails. 
The study team member will address all questions and concerns from the subjects before 
asking the patient to sign the research consent form.  
 
 
B. Statistical Considerations  
 
 
1. Statistical Analysis Plan: Describe the statistical method(s) for the stated specific aims 
and hypotheses described in Section 1. Note: Required for scientific review. 
2. Explain how the overall target sample size was determined (Provide power / sample 
size justification for the study).  
 
If a statistical analysis plan is not appropriate for your study design, please describe a 
plan for assessing your study results. 
 
The primary purpose of this study is to evaluate the Maquet anesthesia workstation in regards to 
savings of volatile agent compared to conventional machines.  As the Maquet workstation is more 
expensive than conventional machines, there must be a substantial cost-savings in terms of 
volatile agent to offset the additional up-front cost.  The typical service life of an anesthesia 
workstation is around 5 years. For powering this study we decided that to be cost-effective the 
Maquet machines must save enough volatile agent in 1.5 years to offset the cost-difference, 
leaving the remaining service lifetime as profit over conventional machines. 
 
 
 
Since volatile agent use is not recorded on a per-case basis, nor is it possible to determine from 
the anesthesia intra-op record, we also needed to estimate the approximate volatile use per case.  
Volatile use increases with length of case, fresh gas flow rate, and vaporizer percent-saturation 
setting.  From pharmacy purchase records, we know that the average monthly Sevoflurane 
purchase over the past two years at UCI is $11,700 ± $6,200.  Averaged out over approximately 
20 OR locations using Sevoflurane daily and about 30.5 days in a month, this gives us $19.2 ± 

 
 
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10.2 per OR per day cost.  Finally, assuming 40 cases per day in the main OR spread over those 
20 rooms gives us two cases per day on average per room, or $9.6 ± 5.0. 
 
The cost difference in the Maquet machines is approximately $50,000 over conventional 
machines, meaning the total Sevoflurane reduction must amount to $50,000 over 1.5 years.  With 
$11,700 per month average over 1.5 years totaling $210,000, a $50,000 reduction represents 
about a 25% reduction in total use. 
 
So, assuming we will have two groups (Maquet and conventional) for which we will measure 
Sevoflurane use during cases, the Maquet machine must use 25% less Sevoflurane to be cost-
effective.  With a per-case cost of $9.6 ± 5.0 for the conventional group, we must have sufficient 
power to differentiate whether the Maquet group has a cost of $7.2 ± 5.0 per case (assuming 
equal case variance for this group).   
 
 
With a power of 0.8 (20% type II risk), a significance level of 0.05 (type I risk of 5%), and using a 
one-sided t-test to compare groups, we require two groups of 55 patients (n=110 total) in each 
group – Group 1: Maquet Anesthesia Machine, Group 2: GE Anesthesia Machine– to detect a 
25% change in cost. An additional 11 subjects (10% attrition rate) will be included to the target 
sample size to account for unforeseen circumstances leading to an exclusion i.e. mechanical 
failure, incomplete data, different anesthetic device etc. 
 
 
 
 
 
SECTION 4: SUBJECTS (PERSONS/CHARTS/RECORDS/SPECIMENS) 
 
A. Number of Subjects (Charts/Records/Biospecimens) 
 
 
1. Indicate the maximum number of subjects to be recruited/consented on this UCI 
protocol. This is the number of potential subjects you may need to recruit to obtain your 
target sample size. This number should include projected screen failures and early 
withdrawals.  Note: The IRB considers individuals who sign the consent form to be 
“enrolled” in the research. 
2. For Mail/Internet surveys include the number of people directly solicited. 
3. If the study involves use of existing charts, records, biospecimens, specify the maximum 
number that will be reviewed/tested to compile the data or the sample population necessary 
to address the research question. 
 
 
1. The maximal sample size is 128 subjects. The target sample size at UCI is 110 
subjects. 55 patients for Group 1 (Maquet), 55 patients for Group 2  (GE machine)  
2. N/A 
3. N/A 
 
 
4. Of the maximum number of subjects listed above, indicate the target sample size for the 
study. This is the number of subjects expected to complete the study or the number 
necessary to address the research question. 
5. For social/behavioral research, the maximum sample size is often similar to the target 
sample size.  If the maximum sample size is significantly greater (i.e., ≥ 1.5x) than the 
target sample size provide a justification. 
6. For studies where multiple groups of subjects will be evaluated, provide a breakdown per 
group (e.g. controls vs. experimental subjects; children vs. adults; by age group).  

 
 
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4. The maximal sample size is 128. To achieve statistical significance, the target sample 
size is 110 subjects with 55 subjects in Group 1 (Maquet) and 55 subjects in Group 2 
(GE Aisys). An additional 11 subjects (10% attrition rate) were included to the target 
sample size to account for unforeseen circumstances leading to an exclusion i.e. 
mechanical failure, incomplete data, different anesthetic device etc. 
5. N/A 
6. N/A 
 
 
7. For multi-center research, indicate the overall sample size for the entire study (across all 
sites).  
 
[ X ] Not applicable - This study is not a multi-center research study. 
 
 
8. Demonstrate that the target sample size will be sufficient to achieve the study goal and 
should coincide with the statistical approach described in Section 3B.  Note: Required for 
scientific review. 
9. Sources and information of assumed group effects and variability should be supplied (e.g., 
pilot data; data from related literature). Note: Required for scientific review. 
 
 
Please reference the Statistical Plan in Section 3.B. for information pertaining to the sufficiency 
of the target sample size. 
 
 
B. Inclusion and Exclusion Criteria 
 
 
1. Describe the characteristics and provide justification for inclusion of the proposed 
subject population. At a minimum include information about the age and gender of the 
study population.  
2. Describe different subject groups (e.g., students and teachers; control group and 
treatment group(s), children and adults) separately. 
 
 
Adult subjects undergoing surgery and scheduled for elective general anesthesia, with ASA 1-
2, will be recruited to participate in this study. 
 
 
3. Provide the inclusion and/or exclusion criteria for the proposed subject population, as 
applicable.  
 
 
[   ] Not applicable – This is not a clinical investigation and/or the characteristics of the 
population sufficiently describe the proposed subject population. 
 
Inclusion criteria: 
 
Age 18-65 years 
 
Undergo surgery under general anesthesia in UCI Medical Center 
 
Agree to sign the consent and HIPAA forms 

 
 
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 
Subjects who are able to receive sevoflurane 
 
 
Exclusion criteria: 
 
 
Subjects under the age of 18 
 
Chronic Obstructive Pulmonary Disease (COPD) 
 
Body Mass Index (BMI) > 30 
 
ASA > 2 
 
Pregnant females 
 
Procedures less than 2 hours 
 
Those with known sensitivity to sevoflurane or other halogenated agents; those with 
known or suspected susceptibility to malignant hyperthermia 
 
Severe Cardiovascular Disease: Left Ventricular Ejection Fraction (LVEF) < 30% 
 
 
4. If exclusion is based on age, gender, pregnancy/childbearing potential, social/ethnic group, 
or language spoken (e.g., Non-English Speakers), provide a scientific rationale.  
 
 
Subjects who are younger than 18 years of age are physiologically different compared to 
the general population and hence, their data will create unnecessary skew when we 
perform statistical tests. Pregnant women have a significantly different respiration 
physiology which would skew data significantly. 
 
 
 
SECTION 5: RECRUITMENT METHODS AND PROCESS 
 
A.  Recruitment Methods 
 
 
Please check all applicable recruitment methods that apply to the study.  Place an “X” in the 
bracket [   ] next to the recruitment method.  
 
 
[   ] This study involves no direct contact with subjects (i.e., use of existing records, charts, 
specimens) 
 
Skip to Section 6. 
 
 
[   ] UCI IRB approved advertisements, flyers, notices, and/or media will be used to recruit 
subjects.  Submit advertisements for IRB approval. 
 
Passive Recruitment - Potential subjects initiate contact with the study team.  
 
Complete Question 5B - Explain where recruitment materials will be posted. 
 
 
[   ] The study team will recruit potential subjects who are unknown to them (e.g., convenience 
sampling, use of social networks, direct approach in public situations, random digit dialing, 
etc.)  
 
Active Recruitment – Researchers contact potential subjects.  
 
Complete Question 5B. 
 
 
[   ] The UCIMC Clinical Trials web page will be used. Submit the UCIMC Standard Research 

 
 
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Recruitment Advertisement for IRB approval.   
 
Passive Recruitment - Potential subjects initiate contact with the study team. 
 
Skip to Section 6. 
 
 
[ X ] The study will be listed on Clinicaltrials.gov. Note: This is required for all clinical trials. 
 
Passive Recruitment - Potential subjects initiate contact with the study team. 
 
Skip to Section 6. 
 
 
[   ] The UCI Social Sciences human subject pool will be used.  Submit the Social Science 
Human Subject Pool Recruitment Advertisement for IRB approval. 
 
Passive Recruitment - Potential subjects initiate contact with the study team. 
 
Skip to Section 6. 
 
 
[   ] Study team members will contact potential subjects who have provided permission to be 
contacted for participation in future research studies.   
 
Active Recruitment – Researchers contact potential subjects.  
 
Complete Question 5B – Explain when and how these individuals granted 
permission for future contact; provide the IRB protocol numbers, if applicable. 
 
 
[ X ] Study team members will approach their own patients, students, employees for 
participation in the study. 
 
Active Recruitment – Researchers contact potential subjects.  
 
Complete Question 5B. 
 
 
[   ] Study team members will send UCI IRB approved recruitment materials (e.g., recruitment 
flyer, introductory letter) to colleagues asking for referral of eligible participants.* 
 
Passive Recruitment – Potential subjects initiate contact with the study team or  
 
Active Recruitment – Colleagues get permission from interested individuals to 
release contact information to researchers. Researchers contact potential subjects. 
 
For Active Recruitment, complete Question 5B. 
 
 *Note: Additional requirements for using this recruitment method are included in the Protocol 
Narrative instructions. 
  
 
[   ]  Study team members will provide their colleagues with a UCI IRB approved introductory 
letter. The letter will be signed by the treating physician and sent to his/her patients to 
inform them about how to contact study team members.  
 
Passive Recruitment - Potential subjects initiate contact with the study team.  
 
The IRB approved letter must be sent by the treating physician. 
 
The study team does not have access to patient names and addresses for mailing.  
 
Skip to Section 6. 
 
 
[ X ] UCI study team members will screen UCIMC medical records to determine subject eligibility 
and approach patients directly about study participation.*  
 
Active Recruitment – Researchers contact potential subjects.  
 
Complete Appendix T to request a partial waiver of HIPAA Authorization.  

 
 
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 
Complete Question 5B. 
 
* Note Additional requirements for using this recruitment method are included in the Protocol 
Narrative instructions.  
 
 
[   ] Other Methods: <indicate the recruitment method(s) here> 
 
Complete Question 5B, as applicable.  
 
 
B. Recruitment Process 
 
 
1. Based on the methods checked above, describe and provide details of the recruitment 
process (i.e. when, where, by whom and how potential subjects will be approached, e.g. 
screening medical charts, findings subjects during routine patient visits, etc.).  
2. If you will recruit by mail, e-mail, or phone, explain how potential subjects’ contact 
information will be obtained. 
3. If active recruitment methods will be used (i.e., researchers will make direct contact with 
subjects for the purpose of recruitment), explain how the individual’s privacy will be 
protected. Note: This is not the same as confidentiality (see the Privacy and 
Confidentiality web page). 
 
 
1. The surgical and interventional schedule at UCI Medical Center’s Main OR will be 
screened by the research team to identify the potential candidate(s). The Lead 
Researcher or Co-Researchers listed in the approved Protocol Narrative will initiate 
study consent, and provide the subject with the consent form during their consultation. 
On the day of the surgery, a study-team member will approach the potential subject to 
confirm the patient’s willingness to participate in research. The Lead Researcher will 
then review the consent form with the patient, answer any questions the subject has 
and will finalize consent. The subject will be asked to sign the research consent form. In 
addition to the full disclosure of the risks and benefits of participating in the study, 
subjects will be informed that their participation is voluntary and their decision will not 
impact their standard of care.  
            
2. N/A 
 
3. The patient’s privacy will be protected. Only the information relevant to the study will be 
obtained. UCIMC study team members will approach eligible subjects (based on prior 
screening of the UCIMC surgical record and patient medical history) and ask for 
consent in a private room. The subjects may choose to have their relatives be in the 
room during this consent process. Study team will make sure that the patient is 
comfortable and have all their questions/concerns answered prior to signing the 
consent form.  
 
 
The patient’s information will be kept confidential; of data is written on paper, the paper 
will be either kept in the research folder which is kept in the hospital or shredded when 
it is not needed. If patient data is kept on a computer, the data will only be stored on 
hospital computers. 
 
 
 
SECTION 6:  INFORMED CONSENT PROCESS  

 
 
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1. Specify how consent will be obtained and describe the specific steps for obtaining 
informed consent.  
2. Include information about when and where consent will take place and the length of time 
subjects will be given to decide whether they wish to participate.  
3. If study team members will approach their own patients, students, or employees for 
participation in the study, explain what precautions will be taken to minimize potential 
undue influence or coercion, and how compromised objectivity will be avoided. 
4. If children are involved in this study, please describe the parental permission process and 
the child assent process.   
5. Be sure to submit the consent/assent document(s) with your e-IRB Application (i.e. Study 
Information Sheet, Recruitment script, Consent Form, etc.).  
6. If this study involves the creation, use, or disclosure of Protected Health Information (PHI), 
specify the process for obtaining HIPAA Authorization. Be sure to submit the HIPAA 
Research Authorization form with your e-IRB Application. 
 
 
Check all that apply: 
 
[ X ] Written (signed) informed consent will be obtained from subjects.  Signed informed 
consent, parental permission, and/or child assent will be obtained from subjects, as 
applicable.  Describe the informed consent process.  
 
[   ] Requesting a waiver of written (signed) informed consent (i.e., signed consent will not 
be obtained). Informed consent, parental permission and/or child assent will be obtained 
from subjects, as applicable.  Explain how informed consent will be obtained.  
Complete Appendix P.   
 
[   ] Requesting a waiver of informed consent (i.e., consent will not be obtained). Complete 
Appendix O.  Skip to Section 7.  
 
 
The Lead Researcher or Co-Researchers listed in the approved Protocol Narrative will initiate 
study consent, and provide the subject with the consent form during their consultation. The 
subjects will have ample time prior to the day of their scheduled procedure to make their 
decision. A written consent form and HIPAA will be required from all subjects.  
 
 
All signed consent and HIPAA forms will be kept at the UCIMC and are only accessible to 
study team members at UCIMC. If the subject refuses to participate, we will immediately 
destroy all screening data related to the subjects and will not enroll the subject in this study. 
 
 
7. Non-English Speaking Participants:  In order to consent subjects who are unable to read 
and speak English, the English version of the consent form must be translated into 
appropriate languages once IRB approval is granted.  
 
 
Check all that apply: 
 
[   ] Not applicable - Only individuals who can read and speak English are eligible for this study. 
 
[ X ] The English version of the consent form will be translated into appropriate languages for 
non-English speaking subjects once IRB approval is granted. An interpreter will be 

 
 
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involved in the consenting process. Note: The IRB must officially stamp the translated 
consent forms.   
 
[   ] Requesting a short form consent process. Complete Appendix Q.  
The short form process will be used for the following languages:  
[   ] All non-English languages  
[   ] All non-English languages except Spanish  
[   ] Other languages (specify): <Type here>  
 
 
 
SECTION 7: RISK ASSESSMENT AND POSSIBLE BENEFITS 
Note: Review of the instructions for this section is strongly recommended. 
 
A. Risk Assessment 
 
 
Place an “X” in the bracket [   ] next to the level of review (based upon the investigator’s risk 
assessment). 
 
 
[ X ] This study involves greater than minimal risk to subjects and requires Full Committee 
review. 
 
[  ] This study involves no more than minimal risk and qualifies as Expedited research.  
Provide justification below for the level of review and for the applicable Expedited 
Category(ies) that you have chosen: 1B. 
 
 
  
 
B. Risks and Discomforts 
 
 
1. Describe the risks/potential discomforts (e.g., physical, psychological, social, economic) 
associated with each intervention or research procedure.   
2. Describe the expected frequency (i.e., probability) of a given side effect or harm and its 
severity (e.g., mild, moderate, severe).   
3. If subjects are restricted from receiving standard therapies during the study, describe the 
risks of those restrictions. 
4. If collecting identifiable private information, address the risk of a potential breach of 
confidentiality. 
 
 
1. All risks are the same as standard of care. 
2. The frequency is no different than standard of care 
3. N/A 
4. The possibility of breach of confidentiality is the same as any standard research. 
 
 
5. Discuss what steps have been taken and/or will be taken to prevent and minimize any 
risks/ potential discomforts to subjects (address physical risks as well as other risks such as 

 
 
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the potential for a breach of confidentiality).  Examples include: designing the study to make 
use of procedures involving less risk when appropriate; minimizing study procedures by 
taking advantage of clinical procedures conducted on the subjects; mitigating risks by 
planning special monitoring or conducting supportive inventions for the study. 
 
Active routine monitoring and other measures will be taken to prevent and minimize any risks 
to the subjects. Subjects will be approached for consent in a private room, given sufficient time 
to sign the consent forms and have their questions answered by the principle investigator. We 
are minimizing study procedures by only recruiting subjects who would already be receiving 
sevoflurane in their surgery as standard of care. To prevent potential breach in confidentiality, 
all study data will be saved on a secure password protected server. All paper recorded data will 
be stored in a locked facility at UCIMC. 
 
 
The MAQUET Flow-i Anesthesia system utilizes an FDA approved low flow system that is also 
being and thus the device meets their standard of care practice. In the event that the MAQUET 
Flow-i does not induce appropriate anesthesia, it will follow the UCIMC standard procedures to 
fix any anesthetic system whether it be MAQUET or a conventional device 
 
 
C. Potential Benefits 
 
 
1. Discuss the potential benefits that may accrue directly to subjects.  Note: Compensation 
is not a benefit. Do not include it in this section. 
 
 
[ X ] There is no direct benefit anticipated for the subjects. 
 
2. Describe the potential societal/scientific benefit(s) that may be expected from this study.   
 
 
Due to the rising cost of healthcare, an accompanying rising concern is the cost of anesthesia 
care delivery. The low volume system has the ability to reduce the usage of anesthetic gas in 
surgical procedures, therefore reducing overall hospital expenditures, and enabling the hospital 
to provide quality patient care at reduced costs.  
 
D. Risk/Benefit Assessment 
 
 
Explain why the study risks are reasonable in relation to the potential benefits to subjects and 
society. 
 
This study does not deviate from the standard of care in use on an already FDA approved 
device. What it does present in risk is in the collection of personally identifiable information, 
consistent with normal scientific collection that will be handled in a standard fashion and as 
described here within. The benefits of the knowledge yielded from this study have the potential 
to transform the industry and deliver justification for adoption of this system and others like it in 
the future to achieve goals.  
 
 
SECTION 8: ALTERNATIVES TO PARTICIPATION 

 
 
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1. Describe the standard or usual care activities at UCI (or study site) that are available to 
prospective subjects who do not enroll in this study, as applicable.  
2. Describe other appropriate alternative procedures to study participation that are 
available to prospective subjects. 
3. If no alternatives exist, indicate that the only alternative is non-participation 
 
 
[ X ] No alternatives exist. The only alternative to subjects is not to participate in the study. 
 
       Subjects will receive standard of care treatment with an FDA approved anesthetic machine 
regardless of participation of this research. 
 
 
SECTION 9: ADVERSE EVENT REPORTING/MANAGEMENT AND COMPENSATION FOR INJURY  
 
A. Adverse Events and Unanticipated Problems 
 
 
1. Indicate that you are familiar with UCI’s Adverse Events/Unanticipated Problems reporting 
policy and procedures.  See http://www.research.uci.edu/ora/hrpp/adverseexperiences.htm 
for details. 
 
 
[   ] Although this study involves no interaction/intervention with research subjects (i.e., 
involves the use of records, charts, biospecimens) an unanticipated problem may still 
occur (e.g., a breach in confidentiality),  the researchers are aware of UCI’s Unanticipated 
Problems involving Risk to Participants or Others reporting policy and procedures and will 
comply with this policy.  
 
[ X ] This study involves interaction/intervention with research subjects. The researchers 
are aware of UCI’s Unanticipated Problems involving Risk to Participants or Others 
reporting policy and procedures and will comply with this policy. 
 
 
2. If this study involves interaction/intervention with research subjects, explain how the 
research team will manage adverse events and unanticipated problems that may occur 
during the study or after completion of the study (i.e., provide a plan).   
 
 
[   ] Not applicable - This study involves no interaction/intervention with research subjects 
(i.e., involves the use of records, charts, and/or biospecimens). 
 
Adverse events and unanticipated problems will be immediately reported to the IRB and the 
sponsor.  If an adverse event occurs during the study, the medical team treating the patient will 
treat and manage the adverse event.  If an adverse event occurs after completion of the study, 
depending on the severity, the patient will be asked to either call 911 or return to UC Irvine for 
treatment. 
 
 
B. Compensation for Injury 
 

 
 
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For Full Committee protocols, explain how costs of treatment for research related injury will 
be covered.  
  
 
[  ]  Not applicable - This study involves no more than minimum risk and qualifies as Expedited 
research. 
 
[ X ]  Researchers are familiar with and will follow UC policy regarding treatment and 
compensation for injury. If subjects are injured as a result of being in the study, UCI will 
provide necessary medical treatment. The costs of the treatment may be covered by the 
University of California, the study sponsor, or billed to subject or the subject’s insurer just 
like other medical costs, depending on a number of factors. The University and the study 
sponsor do not normally provide any other form of compensation for injury.  
 
[   ]  Other:   
 
 
SECTION 10: PARTICIPANT COSTS  
 
 
1. If subjects or their insurers will be charged for study procedures, identify and describe 
those costs.   
2. Explain why it is appropriate to charge those cost to the subjects or their insurers.  
Provide supporting documentation as applicable (e.g., FDA Device letter supporting 
charges). 
 
 
[   ] Not applicable - This study involves no interaction/intervention with research subjects (i.e., 
involves the use of records, charts, biospecimens). 
 
[ X ] There are no costs to subjects/insurers. Subjects will be billed as usual for all related costs 
of their surgical procedure. 
 
 
 
SECTION 11: PARTICIPANT COMPENSATION AND REIMBURSEMENT  
 
 
1. If subjects will be compensated for their participation, explain the method/terms of payment 
(e.g., money; check; extra credit; gift certificate).   
2. Describe the schedule and amounts of compensation (e.g., at end of study; after each 
session/visit) including the total amount subjects can receive for completing the study. 
3. Specify whether subjects will be reimbursed for out-of pocket expenses. If so, describe 
any requirements for reimbursement (e.g., receipt). 
 
Note:  Compensation should be offered on a prorated basis when the research involves multiple 
sessions.  
 
 
[   ] Not applicable - This study involves no interaction/intervention with research subjects (i.e., 
involves the use of records, charts, biospecimens). 
 
[ X ] No compensation will be provided to subjects. 

 
 
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[ X ] No reimbursement will be provided to subjects. 
 
 
 
SECTION 12: CONFIDENTIALITY OF RESEARCH DATA 
 
 
1. Indicate all identifiers that may be included in the research records for the study. Check all 
that apply: 
 
Note: If this information is being derived from a medical record; added to a medical record; 
created or collected as part of health care, or used to make health care decisions it qualifies 
as PHI under HIPAA.  The subject’s HIPAA Research Authorization is required or a waiver of 
HIPAA Authorization must be requested (Appendix T). 
 
[   ] No subject identifiers are obtained (i.e., researchers will not collect information that can link 
the subjects to their data) 
 
OR 
 
 
[ X ] Names  
[   ] Social Security Numbers  
[   ] Device identifiers/Serial numbers 
[ X ] Dates* 
[ X ] Medical record numbers  
[   ] Web URLs 
[   ] Postal address 
[   ] Health plan numbers   
[   ] IP address numbers 
[   ] Phone numbers 
[   ] Account numbers  
 
[   ] Biometric identifiers 
[   ] Fax numbers 
[   ] License/Certificate numbers  [   ] Facial Photos/Images 
[   ] Email address 
[   ] Vehicle id numbers  
 
[   ] Any other unique identifier 
 
[   ] Other (Specify all):  
<Type here> 
 
* birth date, treatment/hospitalization dates 
 
2. Explain how data will be recorded.  
 
 
Check all that apply: 
 
[ X ] Paper documents/records  
[ X ] Electronic records/database  
[   ] Audio recording  
[   ] Video recording    
[   ] Photographs  
[   ] Biological specimens  
[   ] Other(s) (specify):  
 
 
3. Indicate how data will be stored, secured including paper records, electronic files, 
audio/video tapes, biospecimens, etc.  
 
Note: If the research data includes subject identifiable private information and/or Protected 
Health Information, the storage devices or the electronic research files must be encrypted.   
 
 
Electronic Data (check all that apply): 

 
 
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[ X ]  Coded data; code key is kept separate from data in secure location. 
[   ]  Data includes subject identifiable information.  Note: Encryption software is     
       required. (Provide rationale for maintaining subject identifiable info):  
[ X ]  Data will be stored on secure network server.  
[   ]  Data will be stored on stand alone desktop computer (not connected to  
       network/internet) 
[   ] Other (specify here):  
 
Hardcopy Data, Recordings and Biospecimens (check all that apply): 
[ X ] Coded data; code key is kept separate from data in secure location. 
[ X ] Data includes subject identifiable information (Provide rationale for maintaining subject 
identifiable info):  
         
        We will only maintain subject identifiable for organization purposes only. Access to this 
information is limited to only study team members at UCIMC and must be approved by the 
lead researcher. All data will be de-identified before study team conducts any statistical 
tests, sharing data with MAQUET for research purposes. 
 
[ X ] Data will be stored in locked file cabinet or locked room at UCI/UCIMC.  
[   ] Data will be stored locked lab/refrigerator/freezer at UCI/UCIMC. 
[   ] Other (specify here):  
 
 
Data on Portable Devices:  
4. Describe the portable device(s) to be used (e.g. laptop, PDA, iPod, portable hard drive 
including flash drives).  
5. Specify whether subject identifiable data will be stored on the device. If so, justify why it is 
necessary to store subject identifiers on the device.  
 
Note: Only the “minimum data necessary” should be stored on portable devices as these 
devices are particularly susceptible to loss or theft. If there is a necessity to use portable devices 
for initial collection of identifiable private information, the portable storage devices or the 
research files MUST BE ENCRYPTED, and subject identifiers transferred to a secure system as 
soon as possible.   
 
 
[ X ] Not applicable – No study data will be maintained on portable devices. 
 
 
Data Access: 
6. Specify who, besides the entities listed below, will have access to subject identifiable 
private data and records.   
7. If there is a code key, specify who on the research team will hold the key, and who will have 
access to the key. 
8. If publications and/or presentations will include subject identifiable information, specify 
where the data will be published and/or presented and address how the study team will 
obtain permission from subjects. 
 
Note:  Authorized UCI personnel such as the research team and the IRB, the study sponsor (if 
applicable), and regulatory entities such as the Food and Drug Administration (FDA) and the 
Office of Human Research Protections (OHRP), may have access to study records to protect 
subject safety and welfare.  Any study data that identifies the subjects should not be voluntarily 
released or disclosed without the subjects’ separate consent, except as specifically required by 
law.  Publications and/or presentations that result from this study should not include subject 

 
 
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identifiable information; unless the subject’s separate consent has been obtained. 
 
 
[   ] Not applicable – No subject identifiers will be collected.   
[ X ] Not applicable – Only the entities listed above will have access to subject identifiable   
      private data and records.   
 
Only approved study team members at UCIMC will have access to identifiable information for 
research purposes only. The lead investigator will hold the code key and will only distribute to 
study team members when deemed appropriate. 
 
 
Data Retention: 
9. Explain how long subject identifiable research data will be retained. The data may 
include a code with a separate code key or the data may include subject identifiers.   
 
Notes:   
 If more than one of the options below is applicable [e.g., the study involves children], 
records should be kept for the longer period. 
 Research documentation involving Protected Health Information (PHI) should be retained for 
six years (e.g., IRB documentation, consent/assent forms – NOT the actual PHI).  Investigators 
must destroy PHI at the earliest opportunity, consistent with the conduct of this study, unless 
there is an appropriate justification for retaining the identifiers or as required by law. 
 
[   ] Not applicable. No subject identifiable research data will be retained.  
 
[   ] Destroy once data collection is completed 
 
[   ] Destroy at the earliest opportunity, consistent with the conduct of this research. Specify   
       timeframe:  <Type here> 
 
[  ] Destroy after publication/presentation 
 
[ X ] Maintain for approximately <six> years. (e.g., 3 months, etc.)    
 
[   ] Maintain in a repository indefinitely. Other researchers may have access to the data for future 
research. Any data shared with other researchers, will not include name or other personal 
identifying information. Note: Appendix M is required. 
 
[   ] Research records will be retained for seven years after all children enrolled in the study 
reach the age of majority [age 18 in California] as this study includes children . 
 [   ] Research records will be retained 25 years after study closure as this study involves in vitro 
fertilization studies or research involving pregnant women.  
 [ X] As this is a FDA regulated study, research records will be retained for two years after an 
approved marketing application. If approval is not received, the research records will be kept 
for 2 years after the investigation is discontinued and the FDA is notified.  
 [   ] Other: <Type here> 
 
Data Destruction: 
10. If audio or video recordings will be taken, specify the timeframe for the transcription 
and/or destruction of the audio and video recordings.   
11. If photographs will be collected, specify the timeframe destruction of photographs. 

 
 
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[ X ] Not applicable – No audio/video recordings or photographs will be collected. 
[   ] Audio or video recordings transcribed; specify time frame:  <Type here> 
[   ] Audio or video recordings destroyed; specify time frame:  <Type here> 
[   ] Audio or video recordings maintained indefinitely 
[   ] Photographs destroyed; specify time frame:  <Type here> 
[   ] Photographs maintained indefinitely 
 
 
Certificate of Confidentiality: 
12. Specify whether a Certificate of Confidentiality (COC) has been or will be requested from the 
NIH. If yes, explain in what situations personally identifiable information protected by a COC 
will be disclosed by the UCI study team.  
 
Note: If the COC has been secured a copy of the COC Approval Letter should accompany the 
IRB application or be provided to the IRB upon receipt.   
 
 
 
[ X ] Not applicable – No COC has been requested for this study.