A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries
Phase: NA
Conditions: Normothermia
Sponsor: Northwestern University

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 1 of 19 
Revised Template: December 12, 2017 
PROTOCOL TITLE: 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques in Maintenance of Normothermia in Colorectal Surgeries 
PRINCIPAL INVESTIGATOR: 
Meltem Yilmaz, M.D. 
Department of Anesthesiology 
312-695-4310 
yilmaz.meltem@gmail.com 
CO-INVESTIGATOR 
Ljuba Stojiljkovic, M.D. 
Department of Anesthesiology 
312-695-3152 l-
stojiljkovic@northwestern.edu 
VERSION NUMBER: 1.1 
VERSION DATE: 12.12.2017 
Industry Clinical Trial:  VitaHeat Medical, Inc. 
Table of Contents 
 
1.0 
Objectives .................................................................................................................3 
 
2.0 
Background...............................................................................................................3 
 
3.0 
Inclusion and Exclusion Criteria ..............................................................................3 
 
4.0 
Study-Wide Number of Subjects..............................................................................3 
 
5.0 
Study-Wide Recruitment Methods ...........................................................................3 
 
6.0 
Multi-Site Research ..................................................................................................4 
7.0 Study Timelines........................................................................................................4 
8.0 Study Endpoints........................................................................................................4 
 
9.0 
Procedures Involved .................................................................................................4 
 
10.0 
Data and Specimen Banking.....................................................................................5 
 
11.0 Data and Specimen Management .............................................................................5 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects.............................6 
 
13.0 Withdrawal of Subjects*...........................................................................................6 
 
14.0 
Risks to Subjects*.....................................................................................................6 
 
15.0 
Potential Benefits to Subjects...................................................................................7 
 
16.0 
Vulnerable Populations.............................................................................................7 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 2 of 19 
Revised Template: December 12, 2017 
 
17.0 
Community-Based Participatory Research...............................................................7 
 
18.0 
Sharing of Results with Subjects..............................................................................8 
 
19.0 
Setting.......................................................................................................................8 
 
20.0 Resources Available .................................................................................................8 
 
21.0 
Prior Approvals.........................................................................................................9 
 
22.0 Recruitment Methods................................................................................................9 
 
23.0 Local Number of Subjects ........................................................................................9 
 
24.0 
Confidentiality........................................................................................................10 
 
25.0 Provisions to Protect the Privacy Interests of Subjects ..........................................10 
 
26.0 Compensation for Research-Related Injury............................................................10 
 
27.0 
Economic Burden to Subjects.................................................................................10 
 
28.0 
Consent Process......................................................................................................10 
 
29.0 
Process to Document Consent in Writing...............................................................13 
 
30.0 
Budget.....................................................................................................................14 
31.0    Drugs or Devices………………………………………………………………….14 
32.0    Financial Disclosure………………………………………………………………14 
 
1.0 
Objectives 
We propose a study in which we compare two intraoperative active warming 
devices for maintenance of normothermia in patients undergoing colorectal surgery. 
A novel underbody resistive warming mattress (VitaHeat Medical) will be 
compared to the forced air warming blanket (3M Bair Hugger) that is currently used 
in our institution. 
Our hypothesis is that the underbody resistive warming mattress will be equally 
effective as forced air warming in maintaining normothermia in colorectal surgery.  
 
2.0 
Background 
In humans, maintenance of core temperature is tightly regulated by the 
thermoregulatory center in the hypothalamus. However, skin temperature varies in 
differing ambient temperatures due to continuous heat transfer.  Heat transfer from the 
body to the environment occurs by convection, conduction, radiation and evaporation. (1) 
Upon induction of anesthesia thermoregulatory control is impaired which results 
in a significant redistribution of core body heat to the periphery resulting in hypothermia. 
During anesthesia, skin surface is responsible for majority of heat loss. This occurs 
mainly by radiation and convection (90%) and to a lesser degree by evaporation and 
conduction (5% each). (2) 
Hypothermia is recognized as an important risk factor in the development of 
various perioperative complications. Hypothermia induced coagulation abnormality 
increases perioperative blood loss, leading to increased need for blood transfusions. Other 
important complications are surgical site infections, myocardial injury, and longer length 
of hospital stay.  In fact, perioperative hypothermia has been identified as an independent 
risk factor for surgical site infections (SSI). (2) 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 3 of 19 
Revised Template: December 12, 2017 
Colorectal surgery is associated with higher risk of SSI’s than most other 
surgeries. In these surgeries, maintenance of intraoperative normothermia, defined as 
temperature above 36°C, may be particularly challenging. Contributing factors to 
hypothermia include long duration of surgery, extensive surgical exploration, and patient 
positioning. Despite the availability of many warming techniques, many surgical patients 
still exit the operating room hypothermic. Reducing perioperative hypothermia could 
greatly reduce morbidity and mortality in colorectal surgery. 
Devices and methods that are available for prevention of intraoperative 
hypothermia can be grouped into passive and active warming. 
Passive warming with insulating blankets (cotton or reflective) reduce heat loss by 
only 30% (2) and obviously cannot be used alone to maintain normothermia.  
Active warming methods that are most effective are convective and conductive 
warming. Forced air warming has been the standard of care for skin surface warming 
with many studies showing its effectiveness. It is convective heat transfer that relies on 
the amount of exposed skin surface. The efficacy of forced air is decreased when skin 
surface area is limited due to surgical reasons and positioning.  Temperature gradient 
from the hose to the periphery exists makes distribution of heat uneven. Burn injuries 
have been reported when the hose was used alone against manufacturer’s guidelines (4).  
Another group of warming devices are circulating–water garments. These are 
devices that have warm water circulating through a conductive-heating garment that is 
wrapped around the patient. It has been shown to be more effective in heat transfer than 
forced air warming (5) and more effective in patients undergoing abdominal surgery. (6) 
However, potential for leakage, difficulty with handling and higher maintenance costs are 
limiting factors. 
Circulating water and electrical mattresses placed under the patient have been 
ineffective in maintaining normothermia. (7) 
Radiant heaters such as incubators for neonates are used most commonly in 
neonates. Radiators may be used at a safe fixed distance. At this distance the efficacy of 
radiant heat is less than forced air warming. (8) Also a high risk of burn injury exists if 
this safe distance is not maintained. 
Fluid warming (to near 37o C) alone is not effective in maintaining normothermia. 
However, in patients undergoing major surgeries where more than 1 L/hour of fluid is 
administered intraoperatively the combination with other warming techniques have been 
shown to be more effective than the warming device alone. (9) 
  
Resistive heating devices have been shown to be comparable to forced air in 
preventing intraoperative hypothermia. They are multi-part devices controlled by a 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 4 of 19 
Revised Template: December 12, 2017 
central unit making them bulky. Due to their size, cleaning and maintenance may be 
costly. (10) 
VitaHeat is an FDA approved novel underbody conductive heating mattress that 
uses resistive heating technology. This device overcomes some of the deficiencies of the 
older resistive devices. Some of the improved features include silent operation, ease of 
cleaning, reusability and low maintenance. 
In this study, we will compare the efficacy of this new warming device to the 
standard warming technique in patients undergoing colorectal surgery under general 
anesthesia.  
References: 
1. Sessler DI Perioperative thermoregulation and heat balance. Lancet 2016; published 
online on Jan16, 2016 
2. Torosian A Thermal management during anaesthesia and thermoregulation standards 
for the prevention of inadvertent perioperative hypothermia. Best Pract Research Clin 
Anaesth 2008; 22: 659-668. 
3. Sessler DI, Schroeder M. Heat loss in humans covered with cotton hospital blankets. 
Anesth and Analg 1993; 77: 73-77.  
4. Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in 
anesthesia. A closed claims analysis. Anesthesiol. 1994; 80: 806-810. 
5. Taguchi A, Ratnaraj J, Kabon B et al. Effects of circulating-water garment and 
forcedair warming on body heat content and core temperature. Anesthesiol. 2004; 100: 
10581064. 
6. Janicki PK, Higgins MS, Janssen J et al. Comparison of two different temperature 
maintenance strategies during open abdominal surgery: upper body forced-air warming 
versus whole body water garment. Anesthesiol. 2001; 95: 868-874. 
7. Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three 
devices. J Clin Anesth 1992; 4: 194-199. 
8. Bauer, A Weyland W. Kazmaier S et al. Efficacy of postoperative rewarming after 
cardiac surgery. Ann Thorac Cardiovasc Surg 2004; 10: 171-177. 
9. Smith CE, Desai R, Glorioso V et al. Preventing hypothermia: convective and 
intravenous fluid warming versus convective warming alone. J Clin Anesth 1998; 10: 
380-385. 
10. 
Negishi C, Hasegawa K, Mukai S et al. Resistive heating and forced-air 
warming are comparably effective. Anesth & Analg 2003; 96: 1693-1687. 
11. 
Melton GB, Vogel JD, Swenson BR et al. Continuous intraoperative 
temperature measurement and surgical site infection risk Ann Surg 2013;258: 606-613 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 5 of 19 
Revised Template: December 12, 2017 
 
3.0 
Inclusion and Exclusion Criteria 
3.1 All patients’ ≥18 years of age who are scheduled to undergo 
laparoscopic or open colorectal surgical procedures under general 
anesthesia are eligible to participate.  
3.2 Inclusion: Eligible subjects will include patients 18 years of age 
undergoing laparoscopic or open colorectal surgical procedures 
under general anesthesia. 
Exclusion: Patients less than 18 years of age, emergent surgery, 
thyroid problems, preoperative fever and pregnant patients.  
• 
Adults unable to consent: Exclude 
• 
Individuals who are not yet adults (infants, children, teenagers): 
Exclude 
• 
Pregnant women: Exclude 
• 
Prisoners: Exclude 
 
4.0 
Study-Wide Number of Subjects: N/A 
 
5.0 
Study-Wide Recruitment Methods: N/A 
 
6.0 
Multi-Site Research: N/A 
 
7.0 
Study Timelines 
 
7.1 Describe: 
• 
The duration of an individual subject’s participation in the 
study: 30 days 
• 
The duration anticipated to enroll all study subjects.12/31/2018 
 
The estimated date for the investigators to complete this 
study (complete primary analyses).03/01/2019. 
 
8.0 
Study Endpoints 
8.1 
The primary outcome measure will be the percentage of 
intraoperative time above a body temperature of 36oC.              
8.2 
The secondary outcomes will be the amount of blood or blood product 
transfusion, surgical site infections as defined by National surgical quality 
improvement project (NSQIP) and other infections such as urinary tract 
infections, pneumonias, cardiac events such as cardiac arrest and 
myocardial infarction, thromboembolic complications (DVT/PE). Length 
of hospital stay will be recorded as will length of stay, time to return of 
bowel function (time to first flatus) will be recorded. At 30 days following 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 6 of 19 
Revised Template: December 12, 2017 
the surgery readmissions to the hospital, the reason for the admission and 
the length of stay during this additional hospitalization will be recorded.  
 
9.0 
Procedures Involved 
 
9.1 
Study design:  A prospective randomized controlled trial.  
Stratified randomization will be performed using a computerized 
randomization table where the strata will be type of surgery (open vs 
closed) and the treatment will be forced air blanket or underbody mattress 
warming device. This will allow equal groups of both warming devices in 
both types of surgery. 
Group 1: Patients will receive active warming via a heating mattress 
(VitaHEAT Medical) placed on the OR table with two thin sheets between 
the patient and the device; one covering the mattress and the other used as 
the draw sheet as usual practice. The device will be turned on 10 minutes 
prior to the patients’ arrival to the operating room table. Patients’ upper 
body will be covered with blankets. To increase skin surface contact with 
the mattress any blankets remaining under the patients’ chest or head will 
be removed after intubation and replaced with a donut.  
Group 2: Patients will receive standard forced air warming applied to the 
upper body and turned on after the patient is prepped and draped. These 
warmers will be placed directly in contact with the skin without any 
intervening insulation.  
Both groups will have IV fluid warmer initiated on arrival to the operating 
room. The operating room temperatures will be adjusted to 21o C. 
Participation in the study is voluntary. The patients may choose not to enroll in the 
research. Patients who choose not to enroll will use the standard forced air warmer.  
Preoperative and postoperative temperatures will be measured orally. 
Intraoperative core and skin temperatures will be monitored continuously at 1 
minute intervals using an esophageal probe and skin temperature probe using a 
skin temp probe placed on the great toe and covered to prevent any contact with the 
warming devices.   
The total amount of gas flows will be maintained at 2 L/min. Total and fractional 
inspired concentration of oxygen (FiO2) will be maintained 60% in both groups except 
for the periods of induction and emergence. 
A heating mattress (VitaHEAT Medical) will be used as the research device in 
this study. The mattress has regulatory approval. This heating mattress 
(VitaHEAT Medical) is a reusable underbody conductive warming mattress which 
heats to a maximum of 41°C. This device will be compared to the forced air 
warming which heats to a maximum of 43°C. It meets all FDA safety guidelines.  
Temperatures that will be record are: 
Operating room temperatures will be collected at three different times:  

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 7 of 19 
Revised Template: December 12, 2017 
1. upon arrival of the patient to the operating room using a calibrated   
thermometer  
2. at incision  
3. at extubation.  
Patient temperatures will be recorded at: 
1. In the preoperative area (orally)  
2. Skin temperature of the great toe of one hand will be monitored starting 
upon on arrival to the operating room at 1 minute intervals until the 
extubation. This will be performed using a skin temperature probe.  
3. Immediately after intubation following placement of an esophageal 
temperature probe core temperature will be monitored at 1-minute 
intervals. The esophageal temperature probe will be placed by 
measuring the distance from the mouth to the earlobe plus the distance 
from the ear lobe to the manubrium of the sternum-2 finger widths 
below the sternal notch approximately 32-38 cm. (4) Both esophageal 
and skin temperatures will be measured using a band thermometer. 
4. Temperatures will be measured orally and recorded upon arrival and at 
departure from the recovery room. 
At the end of surgery, prior to leaving the operating room, patients’ posterior skin 
surfaces will be inspected for thermal injury and recorded. If at extubation, the 
patient’s temperature is below 36oC, active warming and fluid warmer will be 
reinstituted in the recovery room and modes of active warming recorded.  
Data points collected include: patient demographics, the amount of blood and 
blood product transfusion, blood loss, surgical site infections, along with other 
infections such as urinary tract infections, pneumonias will be recorded. Cardiac 
events such as cardiac arrest and myocardial infarction, thromboembolic 
complications (DVT/PE), any posterior skin surface burn injury, time to first flatus, 
and length of hospital stay will also be recorded.  The participant’s medical chart 
will be accessed to obtain the data points and times mentioned in the data sheet.  
At the 30th day, each participant will be contacted by a blinded member of the study 
team by telephone to be asked questions regarding readmissions to the hospital, the 
reason for the admission and duration of this hospitalization will be asked. The 
phone call will take approximately 2-4 minutes to complete.   
 
10.0 
Data and Specimen Banking: N/A 
 
11.0 
Data Analysis and Management   
The primary outcome measure will be the percentage of intraoperative time above a body 
temperature of 36o C.  Melton GB at el. reported the absolute percentage of time above 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 8 of 19 
Revised Template: December 12, 2017 
the threshold of 36 o C was 57% in patients receiving standard forced air warming 
intraoperatively. (10)   
   
The number of subjects (N=146) was determined for two groups of 73 in each group to 
achieve 83% power to detect a difference of 10% between the active warming underbody 
mattress and forced air warming device, assuming that the standard forced air warming 
method would achieve a value of 57% and that non-inferiority would be set as a marginal 
difference of -10%.  This sample would provide a significance level of 0.042 using a 
onesided Z test. Seven patients will be added to each group for protocol violations and 
data lost in follow up making 160 the total number of subjects that will be recruited.  
Interim analysis is preplanned with two looks at n=74 and n=146. Significance and 
futility boundaries for look 1 and 2 are set at: 
 
The data will be stored in a departmental password-protected computer with a 5-minute 
logout. This computer is accessed behind locked departmental doors. Participants will 
each be assigned an ID number, which will be used as the sole identifier on any 
documents. Subject data will be compiled onto a single password protected file, where 
they will only be identified by their ID number. An enrollment log will be the only file 
where subject names are correlated with ID numbers. This will be kept in a separate, 
secure, password-protected file in the Department of Anesthesiology. Confidentiality is 
secured after transferring the data from paper questionnaires to a password protected 
departmental computer which is uploaded to the departmental server, which is also 
password protected with limited access to study team only. Data (both electronic and 
paper) will be destroyed 3 years after data analysis using current departmental standards 
and vendors. The completed data set is controlled by the PI and only select study team 
members will have access to the data set. The data set will not be transported. The 
departmental computer is located at the Department of Anesthesiology, 676 North St 
Clair Street, Ste 10-501, Chicago, IL 60605. 
11.1 Describe how data will be handled study-wide: 
• 
What information will be included in that data?   
The information on the data sheet, patient code identifier list 
and a copy of the consent.  
• 
Where and how data will be stored?  
Department of Anesthesiology, Arkes Pavilion 10th Floor.  
• 
How long the data will be stored? 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 9 of 19 
Revised Template: December 12, 2017 
The data both electronic and paper will be destroyed 3 years after 
manuscript completion using departmental approved methods of 
destruction.  
• 
Who (role on the study) will have access to the data? 
Authorized study personnel will have access to the data.  
• 
Who (role on the study) is responsible for receipt or 
transmission of the data? Principal Investigator  
• 
How data will be transported? 
All paper data sheets will be kept in binders and stored in a 
locked cabinet in the department of Anesthesiology. Paper data 
will then be logged into in a single computer in the department 
of Anesthesiology by authorized research personnel.  
12.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A 
 
13.0 
Withdrawal of Subjects* 
Participation is voluntary. Participants can withdraw at any time. The data 
collected up to the withdrawal period will be kept for data analysis. 
13.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent, including 
stopping participation for safety reasons. 
Although we have not experienced any issues with the VitaHeat 
underbody mattress, participants may be withdrawn/excluded if the 
device does not work properly. The participants will then receive the 
standard forced air warmer.   
13.2 Describe any procedures for orderly termination. N/A 
13.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection.   
The data collected up to the time of withdrawal or exclusion will be kept 
for data analysis.  
 
14.0 
Risks to Subjects* 
One possible risk is burn injury or skin irritation from the heating mattress but 
multiple sensors that are placed within the blanket prevent the device from 
overheating above 41 degrees C. The risk for loss of confidentiality is another risk 
but strict measures are in place to prevent this from happening. Participants will be 
identified as a participant number an all data will be de-identified. Consents will 
be kept separately from the data collection. 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 10 of 19 
Revised Template: December 12, 2017 
 
15.0 
Potential Benefits to Subjects 
There is no direct benefit to the participants. However, the information may help 
investigators learn more about maintaining core body temperature which may lead to 
less surgical site infections.  
16.0 
Vulnerable Populations N/A 17.0 
Community-Based 
Participatory Research N/A 18.0 
Sharing of Results with Subjects  
The results of the study will not be shared with the participants. The data will be shared 
with VitaHeat. Inc.  
 
19.0 
Setting 
Authorized research personnel will approach potential participants who are scheduled to 
undergo abdominal surgery, specifically colon surgeries such as open or laparoscopic, 
total or partial colectomies, abdominoperineal resections, low anterior resections, and 
proctocolectomies.  
Research recruitment will be performed at the following locations: 
Northwestern Memorial Hospital 
Feinberg Pavilion, Floor 5 
Olson Pavilion, Floor 6 
Prentice Pavilion, Floor 6 
Lavin Pavillion, Floor 11 and 12 
A community advisory board will not be created for this study.  
 
20.0 
Resources Available 
Principal Investigator 
Dr. Meltem Yilmaz is an Associate Professor in the Department of Anesthesiology at the 
Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr. Yilmaz 
has been a faculty member for over 10 years and has contributed chapters for a number of 
textbooks and is published in peer reviewed journals. Dr. Yilmaz has over 8 years of 
research experience in study conduct and design. 
The study co-investigators are qualified for the proposed research project and have 
current Citi-training certificates. All investigators are adequately informed about the 
protocol and their responsible duties. 
20.1 Describe other resources available to conduct the research: For 
example, as appropriate: 
Approximately 2-4 abdominal surgeries are performed per 
week at NMH. If we are able to recruit 8-10 patients per 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 11 of 19 
Revised Template: December 12, 2017 
month, the study will take approximately 9 months to first look 
and 18 months to complete.   
All authorized research personnel will meet prior to the 
conduction of the study to review the documents and 
procedures associated with the study.  
 
21.0 
Prior Approvals 
Department of Anesthesiology Research Committee 
 
22.0 
Recruitment Methods 
22.1 Describe when, where, and how potential subjects will be recruited. 
Potential participants who are scheduled for abdominal surgeries will be 
identified and approached by research personnel. Research personnel will 
approach the patient on the day of the procedure in the preoperative holding 
suite approximately 45 to 90 minutes before surgery. They will explain the 
study and answer all questions that the participants may have.  Patients will 
be recruited at Feinberg pavilion 5th Floor, Olson Pavilion, Floor 6, Lavin 
Pavilion Floor 11 & 12, and Prentice Pavilion floor 6.   
Participants will not be paid to participate.  
 
23.0 
Local Number of Subjects 
The number of subjects to be accrued is 160. There are two groups of 80 subjects.  
 
24.0 
Confidentiality 
Data both electronic and paper stored in departmental server and departmental password 
protected computers will be destroyed using current departmental standards and vendor 3 
years after manuscript preparation. 
 
25.0 
Provisions to Protect the Privacy Interests of Subjects 
25.1 The PI/CO-PI will assure participants that their responses will be held 
anonymous and that the data collected will be used for research purposes. 
25.2 The participants will be allowed to place limits on with whom they 
interact. They will be assured that participation is voluntary. The 
research team will make effort not to make participants feel 
uncomfortable by pressing for information. There are no correct or 
incorrect answers to the questions. 
25.3 Authorized research personnel may access the participant’s medical record 
(Powerchart) to obtain surgical and anesthesia time periods as specified in 
the data sheet.  

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 12 of 19 
Revised Template: December 12, 2017 
 
26.0 
Compensation for Research-Related Injury  
This study is not classified as more than minimal risk 
 
27.0 
Economic Burden to Subjects 
There are no costs to the participants for volunteering to participate in this study.   
 
28.0 
Consent Process 
We will be obtaining informed consent from the participants. The 
consenting process will take place at Northwestern Memorial Hospital, 
Feinberg Pavilion, Floor 5, Olson Pavilion, Floor 6, Prentice Pavilion 
Floor 6, and Lavin Pavilion Floors 11 & 12. 
• 
Any waiting period available between informing the prospective 
subject and obtaining the consent. 
Yes, research personnel will approach the patient on the day of the 
procedure in the preoperative holding suite approximately 45-90 
minutes before surgery. 
• 
Any process to ensure ongoing consent. 
Participation is only 30 days and there will be no further contact with 
the participants.  
• 
Whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
o 
The role of the individuals listed in the application as 
being involved in the consent process. 
Meltem Yilmaz, M.D.: Involved/consent process  
Ljuba Stojiljkovic, M.D, Ph.D.: Involved/consent process 
     Kelsey Oldaker: Involved/consent process  
     Natalie Rodriguez: Involved/consent process o The time 
that will be devoted to the consent discussion. 
The consent will be reviewed with the participant. The participant may 
ask any questions or concerns they may have at this time. There will be 
ample amount of time to read the consent prior to the procedure. 
o 
Steps that will be taken to minimize the possibility of 
coercion or undue influence. 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 13 of 19 
Revised Template: December 12, 2017 
Participation is voluntary and an alternative is not to participate. The 
participant may withdraw from the trial at any time.    
o 
Steps that will be taken to ensure the subjects’ 
understanding. 
The consent will be reviewed with the participant. The participant may 
ask any questions or concerns they may have at this time. There will be 
ample amount of time to read the consent prior to the procedure. 
 
29.0 
Process to Document Consent in Writing 
29.1 Describe whether you will be following “SOP: Written  
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be documented in writing. 
A documentation of consent checklist will be used.   
29.2 If your research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written 
documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement 
to obtain written documentation of consent. Consent Attached 
 
30.0 
Budget  
This is a VitaHeat Medical Inc. sponsored study.  
 
31.0 
Drugs or Devices 
31.1 If the research involves drugs or devices, describe your plans to store, 
handle, and administer those drugs or devices so that they will be 
used only on subjects and be used only by authorized investigators. 
The heating mattress (VitaHEAT) will be stored in the Feinberg 
pavilion 5th floor ready room.  This is a secured area that requires 
badge-card entry. The prentice 6th floor, Olson 6th floor, and Lavin 
Pavilion Floor 11 &12 workrooms are secured by combination lock 
entry or badge-card entry. Research personnel will be responsible to 
ensuring placement in the proper OR room and retrieving the mattress 
after the procedure. Each mattress has an RFI sticker in order to be 
tracked if necessary.  The mattress has been approved and is currently 
used in some cases at Northwestern Memorial Hospital.  
32.0   
32.0     Financial Disclosure:  Dr. Yilmaz, the person responsible for the conduct of this 
research study is a paid member of the Scientific Advisory Board of the company that is 
sponsoring this research. 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 14 of 19 
Revised Template: December 12, 2017 
33.0__COI Management Plan: The principal investigator will disclose her conflict of 
interest on the protocol, consent, and all presentations, manuscripts, and publications that 
arise from this study. The documentation of the operating room temperature will be 
recorded either by authorized research personnel or by the PI. If the PI records the 
operating room temperature, then she will initial the data form signifying that it was she 
who recorded the room temperature. The department statistician will perform the data 
analysis. If there are changes to the financial relationship, the FSM and NUCOI will be 
notified immediately.  
Abdominal Surgery Normothermia Data Collection Form 
PATIENT INFORMATION 
 
Subject #: _________________________                                           Date: ___________________________                                       
Surgeon: ________________________                                              OR Room Number: ___________________ 
Surgical Procedure: _______________________________________________________________________________ 
TEMPERATURE MEASUREMENT 
Pre-Op Temp (Oral) 
Surgery Type (Circle): 
Temp upon arrival to ASU: _________ Time: _________  
Open 
Temp at transfer from ASU: ________  Time:_________  
Laparoscopic 
Epidural:  
Heparin Pre-Op:  
Yes / No (Circle Answer) 
Yes / No (Circle Answer)
_______________________________________________________________________________ 
ANESTHESIA PROVIDER: PLEASE COMPLETE BELOW 
PATIENT Intra-Op Temp 
Patient Position (Circle): 
(Core and Skin)  
Supine 
Ensure that EMR is recording patient 
temperatures at intervals of 1 minute 
Lithotomy 
Operating Room Temp 
Arm position (Circle): 
OR Room temp (upon patient arrival): _______ 
On arm boards 
OR Room temp (at time of incision): _______  
OR Room temp (at time of extubation): _______ 
Tucked 
Warming Device Used (Circle): 
Presence of posterior skin  
Bair Hugger 
VitaHEAT  
surface injury: (for burn injury)
Fluid warmer 
Yes _____ No _____ 
If Yes describe: ______________ 
Anesthesiologist (Print Name):  ________________________________________ 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 15 of 19 
Revised Template: December 12, 2017 
_________________________________________________________________________________ 
PACU DATA SHEET 
Post-Op Temp (Oral) 
Warming Device Used (Circle): 
Temp at admission: _______________  Time: _______ 
Bair Hugger 
Temp at discharge: ________________ Time: _______  
Fluid warmer 
Abdominal Surgery Normothermia Patient De-identifier Code List 
Case  
Name  
Date of 
Surgery 
Medical Record Number 
Telephone # 
1 
 
 
 
 
2 
 
 
 
 
3 
 
 
 
 
4 
 
 
 
 
5 
 
 
 
 
6 
 
 
 
 
7 
 
 
 
 
8 
 
 
 
 
9 
 
 
 
 
10 
 
 
 
 
11 
 
 
 
 
12 
 
 
 
 
13 
 
 
 
 
14 
 
 
 
 
15 
 
 
 
 
16 
 
 
 
 
17 
 
 
 
 
18 
 
 
 
 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 16 of 19 
Revised Template: December 12, 2017 
19 
 
 
 
 
20 
 
 
 
 
21 
 
 
 
 
22 
 
 
 
 
23 
 
 
 
 
24 
 
 
 
 
25 
 
 
 
 
26 
 
 
 
 
27 
 
 
 
 
28 
 
 
 
 
29 
 
 
 
 
30 
 
 
 
 
31 
 
 
 
 
32 
 
 
 
 
33 
 
 
 
 
34 
 
 
 
 
35 
 
 
 
 
36 
 
 
 
 
37 
 
 
 
 
38 
 
 
 
 
39 
 
 
 
 
40 
 
 
 
 
 
41 
 
 
 
 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 17 of 19 
Revised Template: December 12, 2017 
42 
 
 
 
 
43 
 
 
 
 
44 
 
 
 
 
45 
 
 
 
 
46 
 
 
 
 
47 
 
 
 
 
48 
 
 
 
 
49 
 
 
 
 
50 
 
 
 
 
51 
 
 
 
 
52 
 
 
 
 
53 
 
 
 
 
54 
 
 
 
 
55 
 
 
 
 
56 
 
 
 
 
57 
 
 
 
 
58 
 
 
 
 
59 
 
 
 
 
60 
 
 
 
 
61 
 
 
 
 
62 
 
 
 
 
63 
 
 
 
 
64 
 
 
 
 
65 
 
 
 
 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 18 of 19 
Revised Template: December 12, 2017 
66 
 
 
 
 
67 
 
 
 
 
68 
 
 
 
 
69 
 
 
 
 
70 
 
 
 
 
71 
 
 
 
 
72 
 
 
 
 
73 
 
 
 
 
74 
 
 
 
 
75 
 
 
 
 
76 
 
 
 
 
77 
 
 
 
 
78 
 
 
 
 
79..80  
 
 
 
APPENDIX B:  DATA COLLECTION FORM 
Abdominal Surgery Normothermia 
Investigator: Meltem Yilmaz, M.D. 
Subject: ____ ▪ Diagnosis:______________     Date of procedure:___/___/___  Time:______ 
▪Sex:  □M   □F ▪ Weight: ___lbs/kg ▪ Height: ___in   Age: ____ 
▪ Subject Demographics: Caucasian: ___ African American: __ Asian:___ 
  Hispanic: __Middle Eastern: __Other: _________ 
Amount of blood loss________ 
Blood product transfusion given:  ___yes   ____no, If yes____________________________ 
Postoperative opioid consumption:____________________________________________ 
                                                       _____________________________________________ 
Epidural catheter use for pain control?   ___Yes ___No 
Time to return of bowel function (time to first flatus):________________ 

IRB #: STU00202644-MODCR0001 Approved by NU IRB for use on or after 3/14/2018 through 3/13/2019. 
A Prospective Randomized Evaluation of Two Perioperative Active Warming 
Techniques for Maintenance of Normothermia in Colorectal Surgeries 
 
Page 19 of 19 
Revised Template: December 12, 2017 
Infections: 
___urinary tract infections 
___pneumonias 
___cardiac events:   
          __cardiac arrest myocardial,  
          __infarction thromboembolic complications (DVT/PE) 
___Length of stay; Discharge time: _____ 
                                                  Follow up (phone call) 
Where you readmitted to the hospital for any reason?   ___No   ____Yes 
1. What was the reason:____________________________________________ 
2. How long was the length of stay for the readmission? __________________ 
Where you prescribed any antibiotics in the past 30 days?  _____No   ______Yes 
 
1. What is the reason for the antibiotics?  
a) ___Urinary tract infection 
b) ___Pneumonia 
c) ___Cardiac (heart) issues 
d) ___surgical wound infection