Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging
Conditions: Spinal Cord, Epidural
Sponsor: Kenichi Ueda

Transesophageal echocardiography (TEE): A novel 
technique for spinal cord imaging 
NCT Number: 02415244 
Kenichi Ueda, MD 
Document Date: February 1, 2019 

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Transesophageal echocardiography (TEE): A novel technique for spinal cord imaging 
PI: 
Kenichi Ueda 
IRB ID #: 201206753 
Form Content 
I. Project Introduction 
I.1 
Project to be reviewed by: 
IRB-01 
I.2 
Project Title: 
Transesophageal echocardiography (TEE): A novel technique for spinal cord imaging 
I.3 
Short Title (optional): 
I.4 
Provide a short summary of the purpose and procedures of the study proposed in this IRB application. 
DO NOT include information on studies not proposed in this application. 
Use LAY terminology only. This must be easily understandable by IRB community members and 
nonscientists. 
DO NOT cut and paste technical abstracts from funding applications that may not be understood by 
a general audience. 
The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be 
used to identify the structures within the vertebral foramen of the spinal column and to determine the range of 
spinal segments which can be visualized. Data will be collected from both pediatric and adult patients undergoing 
cardiothoracic and interventional cardiac surgeries under general anesthesia. Because use of TEE is a standard 
surgical procedure and because TEE will already be in place to visualize the heart, no additional processes will be 
required to collect data, minimizing patient risk. TEE will be monitored and controlled by a trained anesthesiologist or 
TEE technician and visualization of the spinal cord will be confirmed. Real-time TEE images will then be captured and 
later graded by a trained sonographer as high, medium or low quality. Starting at the level of the tracheal 
bifurcation, corresponding to thoracic vertebral level T5 (Mirajalili 2012), the TEE probe will be advanced cranially to 
determine the spinal levels visualized above T5 and caudally in order to determine the spinal levels below T5 that 
can be seen on TEE. At each level seen on TEE, pictures will be taken for confirmation. 
I.5 
Specify your research question(s), study aims or hypotheses (do not indicate "see protocol") 
The primary outcome is to identify the spinal column and epidural space on real-time TEE image, as well as to 
determine the range of spinal segments that can be visually spanned by TEE. 
The secondary outcomes include classification of the captured TEE image as high, medium or low quality as 
determined by a trained sonographer. 
H0: The null hypothesis is that the spinal cord and epidural space will not be visualized on real-time TEE image. 
H1: The alternative hypothesis is that the spinal cord and epidural space will be successfully confirmed by real-time 
TEE image in all individuals. 
To test this hypothesis, both pediatric and adult patients undergoing cardiothoracic or interventional cardiac 
surgeries under general anesthesia will be included in the study population. 
I.6 
Background and significance and/or Preliminary studies related to this project. 
(do not indicate "see protocol") 
Transesophageal echocardiography is a semi-invasive, monitoring and analytic tool used to generate reproducible 
images of the heart and mediastinum. TEE is routinely used in cardiothoracic and interventional surgeries as well as 
in detecting thromboses, valvular defects and congenital heart disease. There has been expanding utilization of TEE 
outside of cardiac surgery as a potential haemodynamic monitor both intraoperatively and postoperatively (Pissarra 
2012). While TEE is not regularly used to visualize the spinal column, it can be done with relative ease when 
consciously attempted (Chitilian 2006). To our knowledge, this prospective observational study will be the first 
attempt to deliberately image the structures within the vertebral foramen, to scan the spinal segments identified by 
TEE and to classify the TEE image quality by a trained sonographer. Given the nearly universal use of TEE in cardiac 
surgical operating rooms, in combination with the low risk of complications(Daniel 1991), potential outcomes include 
the use of TEE in the placement of thoracic epidural catheters, in identification of spinal cord trauma or as a monitor 
of intraoperative perfusion and pressure surrounding the spinal cord (Godet 1994). This could lead to improved 
precision, success and safety of regional anesthesia. 
I.7 
Literature cited / references (if attaching a grant or protocol enter N/A). 
1. Pissarra F, Oliveira A, Marcelino P: Transoesophageal echocardiography for monitoring liver surgery: data from a 
pilot study. Cardiology research and practice 2012, 2012:723418. 
2. Chitilian HV, Alston TA, Avery EG: Transesophageal echocardiographic bull's eye. Journal of cardiothoracic and 
vascular anesthesia 2006, 20(6):894-895. 
3. Daniel WG, Erbel R, Kasper W, Visser CA, Engberding R, Sutherland GR, Grube E, Hanrath P, Maisch B, Dennig K 
et al: Safety of transesophageal echocardiography. A multicenter survey of 10,419 examinations. Circulation 1991, 
83(3):817-821. 
4. Godet G, Couture P, Ionanidis G, Gosgnach M, Kieffer E, Viars P: Another application of two-dimensional 

HawkIRB 
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=26902851[9/24/2019 11:11:41 AM] 
Prsn COI COI 
transesophageal echocardiography: spinal cord imaging. A preliminary report. Journal of cardiothoracic and vascular 
anesthesia 1994, 8(1):14-18. 
II. Research Team 
II.2 
Team Members 
UI Team Members 
 
 
 
Key  UI VAMC 
Consent 
Name 
E-mail 
College Contact 
 
Process 
Involvement 
Deactivated 
Kenichi Ueda, MD 
Non-UI Team Members 
Name Institution Location FWA Role DHHS Contact 
 
 
Key 
 
 
UI VAMC Consent Process Email 
Nothing found to display. 
II.3 
The Principal Investigator of this study is: 
Faculty 
Prsn COI 
COI 
Involvement 
III. Funding/Other Support 
III.1 
Funding Sources 
Type 
Source Grant Title Name of PI on Grant 
Departmental / PI Discretionary 
* new source name 
III.3 
Does any member of the research team have a financial conflict of interest related to this project according to 
the Conflict of Interest in Research policy? If yes, please indicate which membersbelow. 
Name 
Has Conflict of Interest 
Kenichi Ueda, MD 
No 
Do you want the IRB to give this project 
Regular (expedited or full board) review 
 
 
 
IV. Project Type 
IV.1 
IV.2 
Enter the date you will be ready to begin screening subjects/collecting data for this project. (If you do 
not have a specified date, add "upon IRB approval") 
6/25/2012 
IV.3 
Are you requesting a waiver of informed consent/authorization (subjects will not be given any oral or 
written information about the study)? 
No 
V. Other Committee Review 

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V.1 
Does this project involve any substance ingested, injected, or applied to the body? 
Do not answer yes, if the involvement includes a device, wire, or instrument 
No 
V.2 
Are any contrast agents used for any purpose in this study? 
No 
V.9 
Will any subject be asked to undergo a diagnostic radiation procedure (including radiographic, nuclear 
medicine, DEXA)? 
No 
V.14 
Will any subject be asked to undergo a radiation therapy procedure (including external beam therapy, 
brachytherapy, or nuclear medicine therapy)? 
No 
V.20 
Does this project involve the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or 
RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human research 
participant? 
No 
V.21 
Will any portion of this project be conducted in the CRU, or does it use any CRU resources? 
No 
V.22 
Will this project use any resource/patients of the HCCC? 
No 
V.23 
Will any part of this project be conducted on VAMC premises? 
No 
V.24 
Does this project involve VAMC patients or records? 
No 
V.25 .a 
Will the study involve any of the following activity at UI Health Care, even if subjects or their insurance will 
not be billed for the item or service, and regardless of the study funding source (including studies with 
departmental or no funding)? 
Procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or 
clinical equipment, or any patient care services, including services conducted in the Clinical Research 
Unit; or 
Physician services or services provided by non-physicians who are credentialed to bill (ARNPs, Physician 
Assistants, etc.) 
Yes 
V.26 
The study involves nursing, nursing resources or evaluates nursing practices. 
No 
VI. Subjects 
VI.1 
How many adult subjects do you expect to consent or enroll for this project? 
50 
VI.2 
What is the age of the youngest adult subject? 
18.0 
VI.3 
What is the age of the oldest adult subject? 
90.0 
VI.4 
What is the percentage of adult male subjects? 
50 
VI.5 
What is the percentage of adult female subjects? 
50 
VI.6 
How many minor subjects do you expect to consent or enroll for this project? 
50 
VI.7 
What is the age of the youngest minor subject? 

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0.0 
VI.8 
What is the age of the oldest minor subject? 
17.0 
VI.9 
What is the percentage of minor male subjects? 
50 
VI.10 
What is the percentage of minor female subjects? 
50 
VI.11 
Will any of the minors enrolled be in foster care or Wards of the court? 
No 
VI.13 
Describe EACH of your subject populations 
Include description of any control group(s) 
Specify the Inclusion/Exclusion criteria for EACH group 
Studies under IRB-03 enrolling non veterans as part of the subject population must present a compelling 
argument to the IRB for the inclusion of non-Veterans (e.g., insufficient number of Veterans; survey of 
VA employees; study of active duty military; study involving Veterans’ family members), and the 
research is relevant to the care of Veterans or active duty military personnel. 
The study populations will include 50 pediatric patients and 50 adult patients scheduled for cardiothoracic or interventional 
cardiac surgeries under general anesthesia. We will exclude any patients with known esophageal abnormalities, lesions or 
disease that would disqualify the patient for the use of TEE as standard procedure. We will also exclude any patients that 
come to the catheter laboratory exclusively for TEE exam as our study will only occur in patients already scheduled to 
undergo TEE use in surgery or diagnostic procedure. This will ensure that our study occurs only as a part of standard 
procedure and will not lengthen time under anesthesia or time in the operating room. There is no control population 
needed. 
VI.14 
Provide an estimate of the total number of subjects that would be eligible for inclusion in each of your study 
populations (include your control population if applicable) 
50 pediatric patients and 50 adult patients. There is no control population needed. We expect to complete this study in one 
year. 
VI.15 
Describe how you will have access to each of your study populations in sufficient number to meet your 
recruitment goals. 
Outpatient pediatric and adult cardiac surgery patients will be recruited at the cardiology clinics when patients visit for the 
preoperative evaluation. Inpatient cardiac patients will be identified initially by using the EPIC operating room schedule on 
the day before surgery. We will have access to these populations by working within the Department of Anesthesiology, and 
by monitoring the OR schedule for patients scheduled to undergo cardiothoracic or interventional cardiac diagnosis and 
surgeries. The use of TEE is standard procedure for visualizing the heart in these procedures. A trained TEE operator will 
be available to control and capture images. Patients will be recruited until data has been collected in 50 pediatric patients 
and 50 adult patients. 
VI.16 
Do you plan to recruit/enroll non-English speaking people? 
No 
VI.18 
Do you propose to enroll any of the following in this study as subjects? 
Employee of the PI or employee of a research team member 
Individual supervised by PI or supervised by member of research team 
Individual subordinate to the PI or subordinate to any member of the research team 
Student or trainee under the direction of the PI or under the direction of a member of the research team 
No 
VI.20 
Will subjects provide any information about their relatives? 
No 
VI.23 
Will anyone (other than the subject) provide you with information about the subject (e.g. proxy interviews)? 
No 
VI.26 
Is this project about pregnant women? 
No 
VI.27 
Will this project involve fetuses? 
No 
VI.28 
Does this project involve adult subjects who may be incompetent or have limited decision-making capacity on 

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initial enrollment into the study? 
No 
VI.32 
Does this project involve subjects whose capacity to consent may change over the course of the study? 
No 
VI.37 
Does this project involve prisoners as subjects? 
No 
VII. A. Project Description (A) 
Where will project procedures take place (check all that apply)? 
UIHC - Main Operating Rooms, Pediatric Catheter Laboratory, Pediatric and Adult Cardiac Surgery Clinics 
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative 
project)? 
No 
VII.B. Project Description (B) 
VII.B.1 
Does this project involve any of the following: 
clinical intervention 
pharmacologic intervention 
therapeutic intervention 
physiology studies (e.g. studying the functions of organs, tissues, or cells) 
Yes 
VII.B.2 
Does this project involve a drug washout (asking subject to stop taking any drugs s/he is currently 
taking)? 
No 
VII.B.6 
Will any subjects receive a placebo in this study when, if they were not participating, they could be 
receiving an FDA-approved treatment for their condition? 
No 
VII.B.11 
Is there a separate, written protocol that will be submitted in addition to this IRB New Project form? (Note: a 
grant application is not considered to be a protocol) 
No 
VII.B.18 
Does this project involve testing the safety and/or efficacy of a medical device? 
Yes 
VII.B.19 
Describe in detail procedures in place for maintaining device shipment and receipt records: 
This device is already onsite being used in the UIHC Main Operating Room and Pediatric Catheter Laboratory of 
alternative purposes, thus, no device shipping or receipt will occur. 
VII.B.20 
Who will be responsible for maintaining these shipment and receipt records? 
N/A 
VII.B.21 
Describe in detail procedures in place for tracking use and disposition of devices described in this study: 
N/A 
VII.B.22 
Who will be responsible for maintaining these use and disposition tracking records? 
N/A 
VII.B.23 
Describe in detail procedures in place to limit access to authorized study personnel for the storage, 
control, and dispensing of the investigational devices. (For example, investigational devices are kept in a 
locked area away from approved devices or have a keyed interlock, and only study personnel authorized 
to dispense the device have the keys) 
N/A 
VII.B.24 
Is the device FDA-approved for the way it will be used in this study? 
No 
VII.B.25 
Is there an IDE (Investigational Device Exemption) for this device in this research project? 
No 

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VII.B.29 
Indicate the appropriate FDA status you and/or the sponsor are requesting for the use of this 
device in this study. 
Non-Significant Risk (NSR) device/software 
VII.B.31 
Provide a detailed rationale for why this device meets the FDA definition of a Non- 
Significant Risk Device (NSR) 
Because it is not intended as an implant nor is it to be used in supporting or sustaining human life. 
At this time it is not of substantial importance in diagnosing, curing, mitigating or treating disease. 
VII.B.32 
Provide a summary of prior investigations with this device. 
Transesophageal echocardiography is a semi-invasive, monitoring and analytic tool used to 
generate reproducible images of the heart and mediastinum. TEE is routinely used in 
cardiothoracic and interventional surgeries as well as in detecting thromboses, valvular defects 
and congenital heart disease. There has been expanding utilization of TEE outside of cardiac 
surgery as a potential haemodynamic monitor both intraoperatively and postoperatively (Pissarra 
2012). While TEE is not regularly used to visualize the spinal column, it can be done with relative 
ease when consciously attempted (Chitilian 2006). To our knowledge, this prospective 
observational study will be the first attempt to deliberately image the structures within the 
vertebral foramen, to scan the spinal segments identified by TEE and to classify the TEE image 
quality by a trained sonographer. Given the nearly universal use of TEE in cardiac surgical 
operating rooms, in combination with the low risk of complications(Daniel 1991), potential 
outcomes include the use of TEE in the placement of thoracic epidural catheters, in identification of 
spinal cord trauma or as a monitor of intraoperative perfusion and pressure surrounding the spinal 
cord (Godet 1994). This could lead to improved precision, success and safety of regional 
anesthesia. 
VII.B.33 
Have there been any prior IRB reviews (at UI or elsewhere) and/or determinations 
made with regard to this device? 
Yes 
VII.B.34 
Provide a discussion of these reviews/determinations. 
Yes, as TEE is a standard intraoperative monitor, multiple studies have demonstrated a low 
rate of complications associated with TEE, deeming it safe for use in surgery (Daniel 1991). 
VII.B.35 
Has the FDA made an assessment of risk with regard to this device? 
No 
VII.B.36 
Has this device/software been approved by the FDA for another indication or in another form 
from its use in this project? 
Yes 
VII.B.37 
Describe differences between approved device/software and its use in this study: 
TEE is routinely used in cardiothoracic and interventional surgeries as well as in detecting 
thromboses, valvular defects and congenital heart disease. In this study, TEE will not be used in a 
similar manner but to visualize the spinal column as can be done with relative ease when 
consciously attempted (Chitilian 2006). To our knowledge, this prospective observational study will 
be the first attempt to deliberately image the structures within the vertebral foramen, to scan the 
spinal segments identified by TEE and to classify the TEE image quality by a trained sonographer. 
Given the nearly universal use of TEE in cardiac surgical operating rooms, in combination with the 
low risk of complications(Daniel 1991). This could lead to improved precision, success and safety 
of regional anesthesia. 
VII.C. Project Description (C) 
VII.C.1 
Does this project involve any research on genes or genetic testing/research? 
No 
VII.D. Project Description (D) 
VII.D.1 
Check all materials/methods that will be used in recruiting subjects (you will need to attach copies of all 
materials at the end of the application): 
Use of any information available to the researchers or their colleagues because this person is a patient OR use of any 
information considered to be Protected Health Information (PHI) OR review of patient/clinic records - Operating room 
schedule 
Referral from colleague - Thoracic surgery physicians and nurses may identify potential patients. Also, some patients 
may be identified by Pre-Anesthesia Evaluation Clinic staff. 
VII.D.2 
List the individual data elements you will need to access/use from the patient or clinic records to 

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identify potential subjects for recruitment 
We will need to access patient records to check the patient's eligibility for the study by checking their surgical 
procedure, past medical history, counter indications for TEE use intra-operatively (esophageal trauma, lesion or 
disease) and age. 
VII.D.3 
Describe why you could not practicably recruit subjects without access to and use of the information 
described above 
Many patients may be unaware that they are eligible for the study because they do not understand the routine use 
of TEE in the operating room. Also, patients coming to UIHC for this type of surgery come from all over Iowa and 
surrounding states. Recruitment of eligible patients outside of Iowa City for such a specific study population would be 
extremely difficult. 
VII.D.4 
Describe why you could not practicably obtain authorization from potential subjects to review their 
patient or clinic records for recruitment purposes. 
We could not practicably obtain authorization from potential subjects to review their patient or clinic records because 
the population being studied is very specific. We would have to ask all patients who arrive in the thoracic surgery 
clinic for permission to review their charts in order to identify the possible participants needed. 
VII.D.5 
Describe plans to protect the identifiers from improper use or disclosure 
The only people who will have access to the data collected for this study will be members of the research team. After 
data collection, the data will be immediately transferred electronically to a password protected file on a password 
protected computer and paper files will be kept in a locked filing cabinet in a locked office. 
VII.D.6 
Describe plans to destroy identifiers at the earliest opportunity consistent with conduct of the research 
Paper identifiers will be shredded and electronic identifiers will be completely cleared from computers at the earliest 
opportunity consistent with the conduct of this project. 
VII.D.7 
Does the research team agree that the requested information will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the study, or for other 
research for which the use or disclosure of the requested information would be permitted by the HIPAA 
Privacy Rule 
Yes 
VII.D.8 
Will a member of the research team discuss the study with the subject in person prior to the subject agreeing 
to participate? 
Yes 
VII.D.9 
Describe the physical location where the consent process will take place: 
In most cases the patients will be approached in the Thoracic Surgery Clinic, Pediatric Intensive Care Unit or 
Anesthesia Pre-Surgical Evaluation Clinic approximately 24 hours before surgery. Patients approached in the Thoracic 
Surgery Clinic will recieve a copy of the consent form to take home with them. Those patients who are consented the 
day of surgery will have 1-5 hours before the surgery begins. Patients will be consented before they receive any 
sedation. 
VII.D.10 
Will a member of the research team discuss the study with the subject by phone prior to the subject agreeing 
to participate? 
Yes 
VII.D.11 
Describe: 
If subjects have questions for the research team they are able to contact team members by phone as provided on 
the consent. 
VII.D.12 
Who will be involved in the consent process (including review of consent document, answering subjects' 
questions)? 
Name 
Consent Process Involvement 
Kenichi Ueda, MD 
Yes 
VII.D.15 
Check all materials that will be used to obtain/document informed consent: 
Consent Document 
VII.D.16 
Are you requesting a waiver of documentation of consent (either no subject signature or no written 
document)? 
No 
VII.D.19 
Before the subject gives consent to participate are there any screening questions that you need to directly ask 

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the potential subject to determine eligibility for the study? 
Yes 
VII.D.20 
List any screening questions you will directly ask the potential subject to determine eligibility. 
We will ask if the subject has any known esophageal abnormalities, lesions, disease or other issues that would 
increase risks associated with transesophageal echocardiographic imaging. 
We will ask the subject if they are pregnant or incarcerated. 
VII.D.21 
Will you keep a screening log or other record that would include information on people who do not enroll 
in the study? 
No 
VII.D.25 
After the subject agrees to participate (signs consent), are there any screening procedures, tests, or studies 
that need to be done to determine if the subject is eligible to continueparticipating? 
No 
VII.D.27 
Discuss how much time a potential subject will have to agree to consider participation and whether or not 
they will be able to discuss the study with family/friends before deciding on participation. 
Use of TEE is standard in cardiac surgeries. Patients who are approached in the Thoracic Surgery Clinic will have at least 
24 hours to agree to consider participation in our study. These patients will recieve a consent form to take home for 
further discussion. Patients who are approached on the day of surgery will have 1-5 hours to agree to consider 
participation in the study. All patients will have the opportunity to discuss with family/friends before deciding on 
participation. 
VII.D.28 
How long after the subject agrees to participate do study procedures begin? 
Patients who are consented in the pre-operative clinic will have at least 24 hours between agreeing to participate and their 
surgery. Patients who are consented the morning of surgery will have between one and five hours from the time of consent 
until their surgery. Patients will be consented before they receive any sedation. 
VII.D.29 
Provide a description of the enrollment and consent process for adult subjects 
Describe each study population separately including control population 
Include when recruitment and consent materials are used 
Use 3rd person active voice “The Principal Investigator will identify subjects. For example, the principal 
investigator will identify potential subjects, the study coordinator will discuss the study with subjects 
over the telephone and schedule the first study visit, etc...” 
Describe the steps that will be taken by the research team to minimize the possibility of coercion or 
undue influence during the consent process 
We will identify patients who meet the inclusion criteria by reviewing the pre-operative clinic patient list and operating 
room schedule. All patients will be consented in the same manner. 
In most cases we will approach the patients in the Thoracic Surgery Clinic, Pediatric Intensive Care Clinic or Anesthesia 
Pre-Surgical Evaluation Clinic at least 24 hours before surgery. We will introduce ourselves as members of the anesthesia 
team. We will explain the study and standard TEE procedure, including benefits and risks to the the patient and provide 
them a copy of the consent document. The patients will have the opportunity to ask questions and discuss their 
participation with family or friends. Patients will also recieve a copy of the consent form to take home with them. Patients 
who agree to participate will sign the consent document and will be provided with a copy of the consent. The consent 
document will contain contact information that the patient may use to contact the research team with any questions or 
concerns. 
Those patients who are consented the day of surgery will be approached by a nurse and handed a card which states that 
the patient is elibible to participate in a research study. If they are interested in participating, a member of the research 
team will explain the study to the patient. We will explain the study, including benefits and risks, to the the patient and 
provide them with a copy of the consent document. The patients will have the opportunity to ask questions and discuss 
their participation with family or friends. Patients who agree to participate will sign the consent document and will be 
provided with a copy of the consent. The consent document will contain contact information that the patient may use to 
contact the research team with any questions or concerns. Patients will have between one and five hours after consent is 
obtained before their surgery. No sedation will be given before the consent is obtained. 
Further, in order to minimize the possibility of coercion or undue influence during the consent process, potential subjects 
will be reminded that participation is voluntary and choosing not participate will not affect their surgery/care when they 
discuss the consent for with the research team. 
VII.D.30 
Describe how you will obtain the consent of the parents or legal guardians for child/minor subjects in this 
study 
Describe each study population separately including control population 
Include when recruitment and consent materials are used 
Use FIRST person, and provide detail as to order of events 
Describe the steps that will be taken by the research team to minimize the possibility of coercion or 
undue influence during the consent process 
For children/minors who are too young to assent or consent on their own: 

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We will identify patients who meet the inclusion criteria by reviewing the pre-operative clinic patient list and operating 
room schedule. All patients or their guardians will be consented in the same manner. 
In most cases we will approach the patient's guardian in the Thoracic Surgery Clinic, Pediatric Intensive Care Clinic or 
Anesthesia Pre-Surgical Evaluation Clinic at least 24 hours before surgery. We will introduce ourselves as members of the 
research study team. We will explain the study, including benefits and risks, to the the patient's guardian and provide 
them a copy of the consent document. Guardians will have the opportunity to ask questions and discuss the subject's 
participation with family or friends. Guardians will also receive a copy of the consent form to take home with them. 
Guardians who agree to patient participation will sign the consent document and will be provided with a copy of the 
consent. The consent document will contain contact information that the patient or guardian may use to contact the 
research team with any questions or concerns. 
Those patients who are consented the day of surgery will have their guardian approached by a nurse and handed a card 
which states that the patients is eligible to participate in a research study. If they are interested in participating, a member 
of the research team will explain the study to the patient. We will explain the study, including benefits and risks, to the the 
patient and provide them with a copy of the consent document. The guardian will have the opportunity to ask questions 
and discuss their participation with family or friends. Guardians who agree to patient participation will sign the consent 
document and will be provided with a copy of the consent. The consent document will contain contact information that the 
patient may use to contact the research team with any questions or concerns. Patients will have between one and five 
hours after consent is obtained before their surgery. No sedation will be given before the consent is obtained. 
For children/minors who will sign an assent document or are old enough to sign a consent document: 
We will identify patients who meet the inclusion criteria by reviewing the pre-operative clinic patient list and operating 
room schedule. All patients will be consented in the same manner. 
In most cases we will approach the patient and their guardian in the Thoracic Surgery Clinic, Pediatric Intensive Care Clinic 
or Anesthesia Pre-Surgical Evaluation Clinic at least 24 hours before surgery. We will introduce ourselves as members of 
the research study team. We will explain the study, including benefits and risks, to the the patient and their guardian and 
provide them a copy of the assent document. The patients will have the opportunity to ask questions and discuss their 
participation with family or friends. Patients will also receive a copy of the assent form to take home with them. Patients 
who agree to participate will sign the assent document and will be provided with a copy of the assent. The assent 
document will contain contact information that the patient may use to contact the research team with any questions or 
concerns. 
Those patients who are assented the day of surgery will be approached by a nurse and handed a card which states that the 
patients is eligible to participate in a research study. If they are interested in participating, a member of the research team 
will explain the study to the patient. We will explain the study, including benefits and risks, to the the patient and provide 
them with a copy of the assent document. The patients will have the opportunity to ask questions and discuss their 
participation with family or friends. Patients who agree to participate will sign the assent document and will be provided 
with a copy of the assent form. The assent document will contain contact information that the patient may use to contact 
the research team with any questions or concerns. Patients will have between one and five hours after consent is obtained 
before their surgery. No sedation will be given before the assent is obtained. 
VII.D.31 
What are the plans for the assent process for children/minors in this study? (You may choose more than one 
procedure if you have different child populations in your study) 
Children/minors will sign an assent or consent document - 
No assent procedure because some or all of the children/minors do not have the capability to assent or their 
capability is so limited that they cannot reasonably be consulted to provide assent - 
VII.D.36 
Provide a detailed description and rationale for each of the procedures chosen above and describe the 
child/minor populations to which they apply in your study. 
For those children/minors who are too young (younger than 7 years old) to assent on their own or their capability is so 
limited they cannot reasonably do so, their parent or guardian will consent on their behalf. All procedures and information 
will be explained by a member of the research team and all questions will be answered before consent is obtained. 
For those children/minors that are old enough to sign an assent (7-12 years old) or consent (>12 years old) document, 
they will also have all procedures and information explained by a member of the research team and will be given the 
opportunity to ask questions before assent/consent is obtained. 
VII.D.37 
Does the study include any form of deception (e.g., providing participants with false information, misleading 
information, or withholding information about certain study procedures)? 
Examples: 
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the 
research. 
Participants will be provided with false information regarding the particular behaviors of interest in the 
research. 
Procedures include a confederate pretending to be another participant in the study. 
Participants will be told that the research includes completion of a particular task, when in fact, that task 
will not be administered. 
Study is designed to introduce a new procedure (or task) that participants are not initially told about. 
If yes, a waiver of informed consent must be requested under question IV.3. 
No 
VII.E. Project Description (E) 

HawkIRB 
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VII.E.1 
Will subjects be randomized? 
No 
VII.E.3 
Will any questionnaires, surveys, or written assessments be used to obtain data directly from subjects in this 
study? 
No 
VII.E.5 
Does this project involve creating any audiotapes, videotapes, or photographs? 
No 
VII.E.6 
Provide a detailed description in sequential order of the study procedures following the consent process - DO 
NOT cut and paste from the Consent Document. 
Describe study populations separately if they will be participating in different procedures - include CONTROL 
population if applicable. 
DESCRIBE: 
What subjects will be asked to do/what happens in the study (in sequential order) 
The time period over which procedures will occur 
The time commitment for the subject for individual visits/procedures 
Long-term followup and how it occurs 
The subjects of the study, scheduled to undergo cardiothoracic or interventional cardiac surgeries, will only be asked to 
come to their surgery. The day of surgery the patients will not be required to do anything different from standard 
anesthesia and surgical practice at the hospital. Subjects will come to the operating room suite and the usual monitors 
(electrocardiogram, non-invasive blood pressure, and oxygen saturation) will be placed. 
Following the routine induction of anesthesia, the Mini-Multi TEE probe (Model T6207 (21381A), Philips, Bothell, WA, USA) 
will be advanced to mid esophageal level in order to visualize the heart, this is standard surgical procedure in these cases. 
Rotation of the probe by approximately 180 degrees toward the descending aorta, with an increased gain and depth 
decreased to 2-3 cm, will attempt to allow for appreciation of the spinal cord and epidural space. Upon confirmation of the 
structures within the vertebral foramen by a trained TEE operator, an images of the spine will be captured to be later 
graded as high, medium or low quality by a trained sonographer. The TEE probe will then be advanced caudally and 
intervertebral disc spaces will be counted in order to determine the number of spinal segments that can be spanned until 
an image can no longer be generated. This will take approximately ten minutes, but will occur while the patient is being 
prepared for surgery so no additional time in the operating room will be necessary. At this point, the TEE probe will be 
returned to mid esophageal level to visualize the heart and the operation will proceed as usual. When looking at patient 
medical records, we will only collect the following data: height, weight, age, any known history of esophageal 
abnormalities, lesions or disease and current procedure. Ten minutes is the approximate additional time that may be 
required intraoperatively to observe the spinal cord on TEE but this will not extend the time in the operating room and thus 
no additional billing is required. No additional visits or extra time is required of the subject. There will be no necessary 
long-term follow up or data collection. When the patient leaves the operating room, nothing additional is required. 
VII.E.7 
Will you attempt to recontact subjects who are lost to follow-up? 
No - followup is not required in this study 
VII.E.9 
Will subjects be provided any compensation for participating in this study? 
No 
VIII. Risks 
VIII.1 
What are the risks to subjects including 
- emotional or psychological 
- financial 
- legal or social 
- physical? 
The care the patient will receive is standard practice at UIHC for thoracic or interventional cardiac surgeries and are 
necessary procedures regardless of this research study. Thus, no additional physical risk is involved. Patients may be 
under slightly elevated emotional stress knowing that they are part of a research study. There is a very low risk of loss of 
confidentiality of the patient's medical information, yet this is unlikely as patients will be given identification numbers at 
the earliest date possible and these will only be accessed by members of the research team. Only the data necessary to 
answer the research question will be collected upon reviewing patient information. There are no other known financial, 
physical or legal risks to the patient. 
VIII.2 
What have you done to minimize the risks? 
If applicable to this study ALSO include: 
How you (members of your research team at Iowa) will monitor the safety of individual subjects. 
Include a description of the availability of medical or psychological resources that subjects might 
require as a consequence of participating in this research and how referral will occur if necessary 
(e.g. availability of emergency medical care, psychological counseling, etc.) 

HawkIRB 
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Healthcare professionals will monitor the subject at all times during the operation. The patient will be reassured that 
although they are participating in the study, everything that happens during the case is already standard practice at UIHC 
for thoracic and cardiac surgery patients. All patients will be given an identification number and be referred to by such. To 
prevent loss of confidentiality of the patient's medical information, we will keep all records used for this study in a locked 
office or on password protected computer system. Only members of the research team will have access to the records 
used in this study. No key will be kept as patients will not need to be contacted in the future. 
VIII.3 
Does this study have a plan to have an individual or committee review combined data from all subjects on a 
periodic basis (such as summary or aggregate safety and/or efficacy data)? 
No 
IX. Benefits 
IX.1 
What are the direct benefits to the subject (do not include compensation or hypothesized results)? 
There are no direct benefits to the subject. 
IX.2 
What are the potential benefits to society in terms of knowledge to be gained as a result of this project? 
This novel confirmation method of visualizing the spinal cord and epidural space could be utilized in the future to detect 
spinal trauma, vascular events surrounding the spinal cord or detect hematoma. It could also be used in thoracic epidural 
catheter placement to improve the safety and success rate of epidural analgesia and potentially improve future patient 
care. 
X. Privacy & Confidentiality 
X.1 
What are you doing to protect the privacy interests of the subjects? 
To protect patient privacy, researchers will be conducting the consent and study procedures in a private setting. Further, 
the research team will only be collecting the information necessary to complete the study. 
X.2 
Are you collecting the Social Security Number of any subjects for any purpose? 
No 
X.4 
How will information/data be collected and stored for this study (check all that apply): 
Electronic records (computer files, electronic databases, etc.) - Electronic records will be kept on the password 
protected Anesthesia department server. The members of the research team will be the only people with access to 
the files. No records will be kept on personal computers. Further, patients will be assigned a unique identification 
number. They will always be referred to by this number. The patient's hospital number and day of surgery will be 
recorded, but will not be disclosed to anyone outside the research team. We will record the hospital number only to 
access the patients' chart later if needed. The database that contains the identifiers will be password protected so 
that the only the investigators needing it can access it. No unnecessary patient identifiers will be recorded, and those 
that are needed will be deleted at the earliest possible time. Only data necessary to collect for the study will be 
recorded. 
Name - Dave Griffiths 
Title - System Administrator and System Programmer II 
University Job Classification - IT Security Officer 
Paper/hard copy records (hard copy surveys, questionnaires, case report forms, pictures, etc.) - Paper/hard copy 
records, including consent documents and any other material printed for the study, will be stored in the primary 
invetigator's office in a locked file cabinet. Further, patients will be assigned a unique identification number. They will 
always be referred to by this number. The patient's hospital number and day of surgery will be recorded, but will not 
be disclosed to anyone outside the research team. We will record the hospital number only to access the patients' 
chart later if needed. The database that contains the identifiers will be password protected so that the only the 
investigators needing it can access it. No unnecessary patient identifiers will be recorded, and those that are needed 
will be deleted at the earliest possible time. Only data necessary to collect for the study will be recorded. 
X.5 
Do the confidentiality protections indicated above allow only members of the research team to access the 
data/specimens? 
Yes 
XI. Data Analysis 
XI.1 
Describe the analysis methods you will use, including, if applicable, the variables you will analyze 
We are not planning to compare pediatric vs adult rates, we just want to observe the ability to image the spinal cord using 
TEE in this observational study. Thus, we will only use exploratory descriptive statistics for analysis. 
XI.2 
Provide the rationale or power analysis to support the number of subjects proposed to complete this study. 
Because this is a novel technique, we have no base for the ability to visualize the spinal cord via TEE. We assume that fifty 
pediatric patients and fifty adult patients will provide adequate power to confirm that the spinal cord can adequately be 
observed on TEE image. 

HawkIRB 
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XII. Future Research 
XII.1 
Do you wish to keep any information about subjects involved with this research project so that members of 
the current research team may contact them in the future for your own research projects? 
No 
XII.2 
Do you wish to keep any information about subjects involved with this research project so that other 
researchers may contact them for future research? 
No 
XII.4 
Does this project involve storing any data, tissues or specimens for future research? 
Yes – contribution for future use is mandatory for participation in the study 
New Project Form Attachments 
Attachment Name 
Category 
Ver 
Size 
Attached 
Assent_Ueda.rtf 
Consent & Assent 
Forms 
3 
47 k E 
07/19/12 
Recordofconsent_Final.rtf 
Consent & Assent 
Forms 
2 
57 k E 
06/21/12 
Ueda_Prospectiveconsent_Final722012.rtf 
Consent & Assent 
Forms 
4 
171 k E 
07/19/12 
Ueda reviewer questions.pdf 
Miscellaneous 
1 
71 k E 
07/13/12 
AssuranceUedaTEE18Jun12.pdf 
Assurance 
Document 
1 
74 k E 
06/18/12