Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
Phase: NA
Conditions: Surgery, Temperature Change, Body
Sponsor: University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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ANCILLARY REVIEWS 
 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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☒ Yes 
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this protocol. 
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Exchange (IE)? 
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review will be assigned to your study by 
IRB staff 
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must be 
received 
prior to IRB 
approval. 
 
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process but 
additional 
information 
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study team 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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PROTOCOL COVER PAGE 
 
 
 
 
 
 
 
 
Protocol Title 
Comparison of normothermia maintenance between resistive 
blanket and forced air warming systems in renal transplant 
surgery 
Principal 
Investigator/Faculty 
Advisor 
Name: Cole Bennett, MD 
Department: Department of Anesthesiology 
Telephone Number: 612.402.7900 716-725-7975 
Email Address:   bennettc@umn.edu 
Co-investigator 
Name:  Tjorvi Perry, MD, MMSc 
 
Department: Department of Anesthesiology 
 
Telephone number612-402-7900 
 
E-mail address: perry655@umn.edu 
Scientific 
Assessment 
HRPP facilitated scientific assessmentHRPP facilitated scientific 
assessment 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
Version 43: January June 6, 2022 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
9/24/2021 V2 Adding REDCap for data collection 
No 
2 
1/06/2022 V3 Clarified 4.1, 4.2, 5.2 and 5.3; 
Removed safety monitoring from 
15.4 that belongs in 18; added 
screening patients to 16; and 
added Oncore to 16.7 
No 
3 
6/6/2022 V4 
Remove exclusion criteria of ESRD 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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Table of Contents 
 
1.0 
Objectives 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
8 
4.0 
Study Intervention(s)/Investigational Agent(s) 
8 
5.0 
Procedures Involved 
10 
6.0 
Data and Specimen Banking 
12 
7.0 
Sharing of Results with Participants 
12 
8.0 
Study Population 
12 
10.0 Local Number of Participants 
16 
11.0 Local Recruitment Methods 
16 
12.0 Withdrawal of Participants 
16 
13.0 Risks to Participants 
17 
14.0 Potential Benefits to Participants 
17 
15.0 Statistical Considerations 
18 
16.0 Health Information and Privacy Compliance 
20 
17.0 Confidentiality 
22 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
23 
19.0 Provisions to Protect the Privacy Interests of Participants 
24 
20.0 Compensation for Research-Related Injury 
24 
21.0 Consent Process 
24 
22.0 Setting 
25 
23.0 Multi-Site Research: N/A 
26 
24.0 Coordinating Center Research 
26 
26.0 References 
26 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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ABBREVIATIONS/DEFINITIONS 
FA: Forced air [warming system] 
RB: Resistive blanket [warming system] 
ESRD: end stage renal disease 
PA: Pulmonary artery 
ICU: Intensive care unit 
OR: Operating room 
PACU: Post-anesthesia care unit 
CRNA: Certified registered nurse anesthetist 
NP: Nasopharyngeal 
AUC: area under the curve. In this study, the area under the curve is defined as the cumulative 
summation of the change in temperature from Ti multiplied by the time interval between 
temperature samplings. This gives a surrogate measurement in effectiveness in maintaining 
body temperature 
DSMB: Date and safety monitoring board 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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1.0 
Objectives 
1.1 Purpose:  
The purpose of the study is to compare the effectiveness of resistive blanket 
warming to forced air warming in maintaining body temperature in patients 
undergoing renal transplantation. 
Secondary outcome variables also include: 
• AUC of time versus temperature curves 
• temperatures at set points during operative period 
• Blood loss volumes 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Patients undergoing general anesthesia are less able to maintain body 
temperature compared to the awake state due to several factors: 1) Warmer 
blood normally kept in the torso of the body and organs moves to the limbs and 
to the skin, where heat is lost more easily to the environment through a cold 
operating room, moisture evaporation, and heat loss from the patient through 
heat radiation; 2) The patient is also unable to maintain body temperature since 
shivering is reduced or abolished. Reduced body temperatures can result in blood 
being unable to clot appropriately in extreme circumstances, which leads to 
increased blood loss. The immune system function is also impaired, which results 
in increased infection rates. Shivering after general anesthesia to increase body 
temperature also increases oxygen demand of the body, which can also cause 
increased work of the heart, leading to heart injury. [1,2] For all of these reasons, 
body temperature is continuously monitored and efforts to maintain body 
temperature during surgery are a standard of care.  
The mainstay of maintaining patient body temperature in the operating room is 
through active warming techniques, using conductive or convective heat transfer 
via specially designed blankets. Conductive warming systems work by transferring 
heat directly through skin contact with an electric blanket or a blanket with 
circulating warm water. Convective warming continuously circulates warm air at 
the surface of the skin through air conduits through a blanket that has small holes 
where the air escapes through.  Typically, this forced air warming system (FAWS) 
is only able to warm the patient in areas where the warm air is constantly 
refreshed through convective air currents. [3] Areas of the skin that are in contact 
with the bed or above sterile drapes are not able to be warmed, since warm air 
cannot circulate to those regions, and becomes a particular challenge with 
patients who undergo cardiac surgery, since the amount of body surface area 
available for warming is much lower compared to other surgeries.  

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air warming systems in renal transplant surgery 
 
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2.2 Preliminary Data:  
None 
2.3 Existing Literature: 
Few studies have been done with comparing thermoregulation during prolonged 
transplant surgeries between different types of warming devices.  One quality 
improvement project showed increased core temperature at ICU handoff for 
TAVR and open cardiac surgeries with a water-circulation device. [6] FAWS 
available include upper body, lower body, or under body, however we are 
interested in investigating whether the resistive blanket warming system (RBWS) 
may heat more evenly across the surface area and thereby offer advantages over 
FAWSs.   
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: 
Patient temperature at the end of surgery. 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): 
• AUC of temperature vs time curve during hypothermia (core temperature less 
than 36℃) during the duration of surgery 
Time during surgery spent under 36 degrees through comparison of 
nasopharyngeal temperature, which is measured by placing a nasopharyngeal 
temperature probe 10 to 20 cm into the nare (standard of care) [8], between 
FAWS and RBWS. The study will be conducted as a superiority trial where a 
0.5°C difference between the FAWS and RBWS is considered to be significant. 
• Minimum body temperature upon arrival in PACU 
• Maximum body temperature difference (maximum temperature minus 
minimum temperature) upon arrival in PACU 
• First temperature upon arrive in PACU, last temperature (temperature time 
weighted average) 
• Requiring rescue intervention which will be turning on a second, upper body 
warming blanket if the temperature is consistently below 35.5 degrees 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description:  
Forced air warming system (Bair Hugger, Model 635; 3M Medical, St. Paul, MN, 
USA) 
The forced air warming system has a heater unit that blows air through a conduit 
to an “air blanket” that inflates with forced air that circulates throughout the 

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PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
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blanket, and exits through tiny perforations on the patient-side of that blanket.   
The heat primarily warms the subject through convective means. As the warmed 
air escapes through the perforations in the blanket, it creates an environment of 
continuously circulating warm air that is in contact with the skin. Note, however, 
that warmed air is only able to move over the skin surface in areas of the body 
that are immediately adjacent to the blanket and which are not compressing the 
blanket (and hence blocking airflow).  In many surgical cases, the FAWS is placed 
above the patient so a very large fraction of the patient’s skin area is exposed to 
warm air.  Air blankets are placed under the patient by some providers in 
transplant cases, however, which then results in the blanket conduits then being 
collapsed/occluded by the weight of the patient - and warm air can circulate only 
under a small fraction of the patient's upper torso and legs.  
The Bair Hugger blanket is the standard of care and will be billed as usual to 
insurance.  
Resistive blanket warming system (Hotdog (U102); Augustine Surgical, Inc., Eden 
Prairie, MN, USA) 
This blanket is equivalent to an operating-room-safe electric blanket. Through a 
power cord, a separate power source powers a semiconductor layer within the 
resistive blanket to generate heat. The heat primarily warms the subject by 
conductive warming through direct skin contact, and, secondarily, by warming 
the air around the participant in areas where there is no direct skin contact. 
The participant will be placed on ether the underbody FAWS or the RBWS on the 
operating room table depending on which device the patient is randomized to, 
this will then be the main warming device during the surgery. The main warming 
device will be turned on once the patient is positioned on the operating table. 
An additional upper body FAWS will be placed on top of the patient prior to 
surgery for rescue purpose and will only be utilized if normothermia cannot be 
achieved during the surgery with the device the patient is randomized to. During 
periods when the participant will need to be warmed, the additional upper body 
device will be switched on to generate heat in addition to the main warming 
device. 
The Hotdog blanket will be donated by the manufacturer. The Anesthesiologist 
will train CRNA staff on the use of this device and will maintain continual 
communication with the CRNA Lead to ensure staff is aware of the study and 
receives proper training. A staff member from the Anesthesiology Research Office 
will be in charge of the inventory  of  the donated blankets, stored in the core of 
the OR department. A research team member will bring the Hotdog device to the 
OR prior to surgery, if the patient is randomized to Hotdog and will make sure 
there is a rescue Bairhugger in the OR for all patients. After the surgery, OR staff 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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will do their normal process of cleaning supplies, including the Hotdog, and will 
put the device back in the OR core. 
The HotDog resistive blanket warming system is FDA approved and available for 
use in surgery. 
4.2 Device Handling:  
During the study, the participant will be randomized to lay on top of either the 
underbody forced air warming system or resistive blanket, this will be the main 
warming device for the patient.  An additional upper body device will be placed 
on patients in case rescue warming is needed at the discretion of the 
anesthesiologist. All staff participating in patient care will be instructed that a 
patient’s body temperature of 35.5 degrees Celsius or lower is the threshold for 
intervention.  During periods when the participant will need to be warmed, the 
additional upper body device will be switched on to generate heat in addition to 
the main warming device. 
Forced air warming blankets are single patient use only. The resistive blankets are 
reusable. In between use, the resistive blankets will be cleaned and disinfected 
per manufacturer’s instructions. 
4.3 Biosafety: N/A 
4.4 Stem Cells: N/A 
4.5 Fetal Tissue: N/A 
5.0 
Procedures Involved 
5.1 Study Design: 
Single institution, prospective, randomized, unblinded superiority study of renal 
transplant surgery participants, with no history of previous transplant, comparing 
a resistive blanket warming system (Hotdog (U102); Augustine Surgical, Inc., 
Eden Prairie, MN, USA) to a forced air warming system (Bair Hugger, Model 635; 
3M Medical, St. Paul, MN, USA). 
A randomization schedule will be developed using permuted block randomization 
with blocks of size 2, 4, 6, and 8 assuming 1:1 allocation within each block. Data 
will be analyzed using an intention-to-treat protocol. 
5.2 Study Procedures:  
The study will involve two arms: a resistive blanket warming system arm and a 
forced air warming system arm. Both devices will be set to warm the patient at 
each device’s maximum setting at the beginning and throughout the case. The 
hotdog’s maximum setting is 39C and the Bair Hugger’s maximum setting is 41C.  
The patient will be randomized to either the FAWS or RBWS before arrival to the 
operating room. Depending on which arm they have randomized to, the 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Comparison of normothermia maintenance between resistive blanket and forced 
air warming systems in renal transplant surgery 
 
VERSION DATE: V43 January June 6, 2022 
 
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participant will be placed on either the underbody FAWS or the RBWS. An upper 
body FAWS will be placed on top of the patient prior to incision but is only to be 
utilized if normothermia cannot be achieved during the surgery with either 
device. The warming system that the patient is randomized to will be set up on 
the table before the participant is brought to the OR and transferred to the 
operating room table. The main warming device will be turned on once the 
patient is positioned on the operating table. The CRNA’s will be involved in the 
placement of the blankets. Surgeons, OR Nurse Managers, and CRNA’s will be 
informed by research team regarding patient’s involvement in the study.  
After the needed standard monitors for surgery have been placed, general 
anesthesia will be induced and maintained with patient’s hemodynamics and 
other vitals maintained per standard care (no additional measurements beyond 
standard of care which is recorded in EPIC). Standard anesthetic care of the 
participant will occur for the duration of the surgery.  
Patient core temperature will be measured with a nasopharyngeal temperature 
probe. The patient’s temperature will be monitored and recorded for the 
duration of surgery with the selected warming system.  Vital signs, including 
continuous blood pressure, heart rate, oxygen saturation, and end-tidal carbon 
dioxide, will be monitored and recorded in Epic as is routine with all anesthetics 
performed. Our primary outcome variable is the NP temperature as recorded at 
the end of the surgery. 
   
After the surgery, the patient will be transported to the PACU in a timely fashion. 
Temperature measurement in the PACU will be standardized with skin 
temperature probes (3M Spot-On) that will be placed on the forehead prior to 
leaving the operating room. If there is an unexpected delay in transporting the 
patient to the PACU, that will be documented and the temperature upon arrival 
to PACU will not be valid. 
Data to be collected about participants and the source records that will be used 
to collect those data:    
From Epic:   
• Age 
• Sex 
• MRN 
• Height 
• Weight 
• BMI 
• Date of procedure 
• Procedure performed 

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air warming systems in renal transplant surgery 
 
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• Nasopharyngeal temperature throughout surgery (every minute) 
• Time at warming system being switched (resistive blanket or forced air) 
• Time when patient reaches 37˚C 
• Time at OR departure 
• Time sign-out from PACU prior to transfer to regular nursing floor 
• Blood product volume administered to patient (red blood cells, fresh 
frozen plasma, platelets, and cryoprecipitate) 
• Recorded incidence of rescue warming used for when patient’s 
temperature is at 35.5˚C (requiring rescue means the need to turn on the 
additional forced air warming device that may be due to severe 
hypothermia and uncontrolled bleeding) 
Individually Identifiable Health Information: See above 
HIPAA Agreement:  Attached 
5.3 Study Duration:  
Individual Subject Participation Duration: Patients will be in the study for their 
scheduled procedure and for 1 hour following their procedure. Duration of the 
surgical procedure, is typically 2-5 hours depending on the surgery required. 
Following the study, participants will not be approached at any time, for any 
reason as it pertains to their study participation. 
Total Study Duration (all Participants): approximately 1 year 
Total Study Duration Including Data Analysis: about 14 months 
5.4 Use of radiation: N/A 
5.5 Use of Center for Magnetic Resonance Research: N/A 
6.0 
Data and Specimen Banking 
6.1 Storage and Access: The storage and access to study data will be HIPAA compliant 
6.2 Data: Data will be entered in REDCAP and stored in UMN Box Secure storage. 
Signed Informed Consents in paper form will be stored in the Anesthesia Research 
Office.  
6.3 Release/Sharing: Data will be stored internally within the research group. Data 
will not be shared with the company providing the RWBS. 
7.0 
Sharing of Results with Participants 
7.1 Individual participant results will not be shared. High-level summary study results 
may be publicly available in a publication of research results in a scientific journal.  
7.2 Sharing of genetic testing: N/A 
8.0 
Study Population 

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air warming systems in renal transplant surgery 
 
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8.1 Inclusion Criteria: 
• Eighteen (18) years to 90 years old 
• Undergoing elective renal transplantation 
8.2 Exclusion Criteria: 
• Previous surgery involving organ transplantation or nephrectomy. These 
patients are at higher risk of blood loss, making temperature regulation 
subject to more variables outside our control.  
• End stage renal disease with decreased or no urine output from normal. 
• Previous upper extremity amputations 
• Ongoing sepsis or other infection 
• Thyroid dysfunction 
• Emergency surgery 
• Refusal of consent to participate in study 
• Pregnancy  
8.3 Screening: 
First, potential participant’s chart in Epic will be accessed to ensure they are not 
“Research Opt Out” (will not be approached by research team). Participants will 
be seen in the preoperative holding area before surgery. Participants will be 
identified before the procedure either by participating anesthesiologists or 
transplant surgeons when an organ is available and a renal transplant surgery is 
scheduled. An approved member of the research team will be notified when the 
case is scheduled and the recipient has been sent for. This individual will then 
discuss the nature of the study and obtain consent. In all cases, a member of the 
anesthesia team will be available (either in person or via phone) to directly 
answer any questions that cannot be addressed by a non-physician member of 
the team. 
9.0 
Vulnerable Populations 
9.1 Vulnerable Populations:  
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Excluded from 

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ParticipationExcluded from 
Participation 
Pregnant women/fetuses/neonates 
Excluded from 
ParticipationExcluded from 
Participation 
Prisoners 
Excluded from 
ParticipationExcluded from 
Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded from 
ParticipationExcluded from 
Participation 
Non-English speakers 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Those unable to read (illiterate) 
Excluded from 
ParticipationExcluded from 
Participation 
Employees of the researcher 
Excluded from 
ParticipationExcluded from 
Participation 
Students of the researcher 
Excluded from 
ParticipationExcluded from 
Participation 
Undervalued or disenfranchised 
social group 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 

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air warming systems in renal transplant surgery 
 
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Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Excluded from 
ParticipationExcluded from 
Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Included/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded from 
ParticipationExcluded from 
Participation 
9.2 Additional Safeguards:  
Language: Patients with any primary language other than English will be 
considered for inclusion, so long as there is a professional interpreter available for 
the consent process and other aspects of the study. The study does not target 
participants with any specific language. A short form, if available, will be used if 
the subject is non-English speaking. 
Undervalued social group: Research staff will not be asking about this social 
group, however vulnerability will not be increased by participating.  
Military: Research staff will not be asking about this social group, however 
vulnerability will not be increased by participating. 
Stressful Situation: Given that participants are approached in the pre-op area 
prior to surgery, this may be a stressful situation. Extra caution will be taken as to 
not coerce the potential participant. They will be encouraged to ask questions of 
the research team or PI/Sub-PI and will be given adequate time to discuss with 

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their support. Individuals who are noticeably nervous or stressed at that time will 
not be consented.  
Disadvantaged group: Research staff will not be asking about this social group, 
however vulnerability will not be increased by participating. 
Fear of Participating: Research staff will not be asking about this social group, 
however vulnerability will not be increased by participating. 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: 130 
10.2 Basis for Sample Size Calculation: 
The sample size of 98 total patients was calculated in consultation with a 
statistician on the assumption that there would be a significant mean difference 
of 0.5°C (SD=0.75) (see Section 15.2 for more details). To account for an 80% 
enrollment rate, we estimate we will need to approach 123 patients for the study. 
11.0 Local Recruitment Methods 
11.1 Recruitment Process:  
Participants who will be undergoing renal transplant surgery at the University of 
Minnesota – Fairview East Bank.  Given the uncertain nature of matching organs 
to potential recipients, the potential recruits will be identified through the 
operating room schedule the day of their surgery. The research team will ensure 
that it does not interrupt that pre-op workflow. The nurses will be informed of 
the study and ahead of time. 
A research assistant or one of the investigators will discuss with the patient the 
goals of the study and answer any questions the participant and the participant’s 
family may have about the study. Consent will also be obtained by the research 
staff. Any additional questions the research assistant is unable to answer will be 
answered by the investigators of this study. A copy of the consent will be given to 
the patient, one will remain in the patient’s medical record and the original will 
be securely stored by research staff.  
11.2 Identification of Potential Participants:  
Participants who will be undergoing renal transplant surgery at the University of 
Minnesota – Fairview East Bank. Potential participants will be approached prior to 
their surgery by the operating room schedule that day (see above mentioned 
safeguard in 11.1). 
11.3 Recruitment Materials: N/A 
11.4 Payment: None 
12.0 Withdrawal of Participants 

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12.1 Withdrawal Circumstances:  
The patient's physicians (either surgeon or anesthesiology) may withdraw 
patients from the study without their consent if there are any concerns for 
patient safety (whether related to the study or not).   
12.2 Withdrawal Procedures: 
Participants may withdraw at any time from the study after consenting for 
participation up to induction of anesthesia and may withdraw from the study 
after the surgery (the participant will be unconscious after induction of 
anesthesia and will be unable to withdraw while under anesthesia). Data 
collected for the study may be retained unless the participant requests otherwise, 
in which it will then be deleted/destroyed. However, all typical data recorded for 
the intraoperative anesthetic record will continue to be collected in the patient’s 
chart for patient care and documentation. 
12.3 Termination Procedures:  
The patient's physicians (either surgeon or anesthesiology) may terminate the 
study at any time if there are concerns for patient safety (whether related to the 
study or not).   
13.0 Risks to Participants 
13.1 Foreseeable Risks: 
None beyond those routinely associated with transplant surgery and anesthesia 
and temperature management. Thermal injury to the skin (with or without actual 
burns) is listed as a risk for all warming systems that contact the skin (including 
both forced air and resistive blankets) but such events are exceedingly rare when 
the equipment is used as intended. We will use the devices according to the 
manufacturer’s recommendations of operating the devices. 
Participation in research may involve a loss of privacy due to the nature of the 
questions that are asked and/or data collected. However, records will be handled 
as confidentially as possible. No identifying information will be used in any report 
or publications that may result from this study. All study records will be kept in a 
UMN box and REDCap which are secure databases. Paper records will be kept in 
locked cabinets in locked rooms only accessible to study staff. 
13.2 Reproduction Risks: None 
13.3 Risks to Others: N/A 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: 

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Aside from stated benefits from maintaining normothermia in the perioperative 
period in this proposal, there are no other additional benefits for subjects in 
participating in this study. 
15.0 Statistical Considerations 
15.1 Data Analysis Plan: 
1. Our primary outcome variable is the patient’s temperature at the end of 
surgery. 
2. Secondary outcome variables also include: 
• AUC of time versus temperature curves;  
• temperatures at set points during operative period;  
• blood loss volumes  
All continuous measures will be summarized with mean (standard deviation) or 
median (interquartile range) based upon evaluation of normality using statistical 
tests (e.g., Shapiro-Wilk) and graphical representation (e.g., histograms, 
boxplots). Categorical measures will be summarized by count (percent). 
The secondary outcomes are continuous measures and will be compared using 
two-sided two-sample t-tests for unadjusted comparisons of the groups. Adjusted 
comparisons will use linear regression models to account for potential 
confounders that may affect the outcome based upon the clinical literature. 
Safety outcomes of interest include the incidence of hyperthermia, rescue 
warming, and incidence of thermal injury. These are categorical variables and will 
be compared using the χ2 test or Fischer’s exact test for unadjusted comparisons 
and with logistic regression models to account for potential confounders.  
Final data set will be assessed for missing data, depending on rate of missing 
data, we will use statistical methods to account for missing data 
15.2 Power Analysis: 
A mean difference of 0.5°C in patient temperatures between the two devices 
would be clinically meaningful. However, limited data exists, so a range of 
standard deviations were explored to examine the different sample sizes needed 
at 80% and 90% power (assuming a two-sided two-sample t-test with α=0.05). 
 
Power 
SD 
N per 
Group 
Overall 
N 
0.8 
0.25 
6 
12 

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0.5 
17 
34 
0.75 
37 
74 
1 
64 
128 
0.9 
0.25 
7 
14 
0.5 
23 
46 
0.75 
49 
98 
1 
86 
172 
 
We will take a conservative approach by enrolling 49 patients per group (98 
patients total). As this is a minimal risk study, we expect to an 80% enrollment 
rate; we will approach (98 + 20% = 123 patients). In 2019, the University of 
Minnesota Medical Canter performed approximately 240 renal transplants for a 
total of ~200 eligible patients or ~16 eligible patients/month; 100 total patients 
approached/16 eligible patients per month = 6.25 months. 
15.3 Statistical Analysis:  
Data will be collected in REDCap and stored in an excel spreadsheet format in box 
and analyzed in-house with a statistician.   
All analyses will be conducted using R or SAS statistical software. Values of p<0.05 
will be considered statistically significant. The analyses will use the intention-to-
treat approach. The primary outcome will assume a complete case analysis, but 
when data is missing, methods for imputation will be explored based on the 
amount and type of missing data, potentially including multiple imputation using 
the mice package in R or linear interpolation methods for measures repeated 
over time that are missing for sensitivity analyses. 
15.4 Data Integrity: 
Data will be recorded automatically into the EPIC electronic health record system 
and will be extracted using computer algorithms/programs that have been tested 
for data extraction either by the research team or by the EPIC data team at 
Fairview. Any data extracted from the Vigilance II monitor with the VitalDB 
software package will be performed in real-time to a hospital-owned computer 
dedicated to the research team. 
Data will be stored on hospital, password-protected computers via UMN Box. This 
will include laptops. Data will not be stored on personal computers of any kind, 

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including smartphones. The computers will be stored in a locked office in the 
hospital, and only the research team will have access to these computers.  
16.0 Health Information and Privacy Compliance 
16.1 Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
☒ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: N/A 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
16.2 Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
☐ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☒ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe: 
16.3 Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
Patients on the surgery schedule for renal transplants will be screened before 
being approached by research to ensure that they have not opted-out of 

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research and meet criteria for approaching. For data collection, research staff 
will only be accessing records of patient’s with a signed consent. Participants 
who have withdrawn from the study will not be included.  
16.4 Approximate number of records required for review: 200  
16.5 Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication 
with research participants. 
☒ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment (consent and assignment to one of two 
warming methods) 
☐ Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants.  
16.6 Explain how the research team has legitimate access to patients/potential 
participants: 
Study staff approaching participants are part of the surgical team 
(anesthesiology). All study staff involved in this study have successfully 
completed all regulatory requirements (HIPPA, CITI, GCP, Fairview 
requirements). Privacy is taken very seriously and only consented patients will 
be accessed.  
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☒  In REDCap (recap.ahc.umn.edu)  
 ☒  Store 
☒  Analyze 
☒  Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☒  In OnCore (oncore.umn.edu)  

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 ☒  Store 
☐ Analyze 
☒  Share 
☒ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:   
 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other. Describe:  
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as a tablet or smartphone not previously listed 
16.8 Consultants. Vendors. Third Parties: Data will not be shared with the company 
supplying the product. 
16.9 Links to identifiable data: N/A 
16.10 Sharing of Data with Research Team Members: Team members will use box to 
share data. No email or other systems will be used.  
16.11 Storage and Disposal of Paper Documents: Signed paper consents will be 
securely stored in a regulatory binder for 5 years. 
17.0 Confidentiality 
17.1 Data Security: 
Only the core study team (PI, co-PI, and support personnel) will have access to 
PHI and data during the initial collection process. Intraoperative recording of 
relevant events for the study will be recorded on paper or in REDCap on an IPAD 
in the operating room, which will be imported into REDCap and saved in box in a 
way that de-identifies the data. Intraoperative subject vitals will also be exported 

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from EPIC into spreadsheet format and be saved on research computers in a de-
identified fashion. Data collected by the VitalDB software package will be done in 
real-time to a hospital-owned computer for use dedicated to the research team, 
and will have no patient identifiers except for date and time of the data collected, 
and subject number, and will be merged into the spreadsheet containing the data 
imported from EPIC. Data will then be processed on these computers that are 
dedicated solely to the research team. A separate spreadsheet of PHI (patient 
name, MRN, date of surgery, procedure) will be compiled of study subjects in the 
case additional information needs to be collected or verified. The spreadsheet 
with PHI and data spreadsheets will be saved in an encrypted format in BOX. All 
computers that are dedicated to the research team will not leave the research 
site (Fairview hospitals, University of Minnesota) and be secured in a locked office 
when not in use. Transmission of data will be performed within approved 
University storage and transfer modalities (encrypted e-mail, local network 
drives, etc.). Original consent documents and data collected on paper, which will 
include patient information, will be stored in a locked cabinet in a locked research 
office, accessible only to the core study team. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring: 
A detailed review of all participants and participant data will be conduct at 
monthly intervals by the PI or co-PI to ensure data is being recorded and analyzed 
appropriately. Any missing data or abnormal data findings will trigger a detailed 
review of raw data from EPIC and measures will be taken to train the staff to 
minimize the chance for recurrence and to improve the process of data collection 
and analysis. The PI or co-PI will also review EPIC records of each subject to verify 
protocols were followed and to note if any adverse events occur, and if any 
rescue interventions were implemented and implemented correctly. 
Any adverse events, whether related to the study or not with regards to 
temperature management, will be reported to the study team in addition to chart 
review. An adverse event log will be maintained, with events reported to the IRB. 
If there is any question as to whether the event was related to the study, the case 
will be referred to Dr. Michael Todd, the Department of Anesthesiology's Vice 
Chair for Research and the Departments Quality Assurance Event monitor, for 
review and adjudication.  Dr. Todd will be empowered to temporarily halt 
enrollment if any safety concerns are noted - although the final decision regarding 
halting or resuming the study will be referred to the Department of 
Anesthesiology’s DSMB (see below for details). 
18.2 Data Safety Monitoring: 
The Department of Anesthesiology has a designated "DSMB" headed by Dr. Joyce 
Wahr and including Drs. Richard Prielipp and Michael Todd. Given the low risk 

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nature of this study, our plan is for the DSMB to receive blinded (A vs B) data 
after the completion of the 55th patient (the halfway point). While statistical 
stopping rules for non-inferiority studies remain uncertain, we will use a well-
established O'Brien-Fleming procedure and will stop the study if the SUPERIORITY 
of either method is established, based on an intergroup Z-score difference of 
2.78.    
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy:  
The participants will be provided written information by the research team about 
the study and be contacted in person to assess their willingness to participate in 
the study. After the perioperative period, there is no planned additional follow-up 
to be performed by the research team. The data and information collected by the 
research team in relation to the participant will be handled in accordance to 
HIPAA and will be saved in password-protected file formats and password 
protected USB drives, if applicable, and data will be transferred within internal 
network drives and via UMN Box secure internal data storage services. All data, 
once collected, will be de-identified of participant data for data processing 
purposes with a spreadsheet linking participant information to datasets saved in a 
password-protected electronic spreadsheet, and a backup paper spreadsheet 
secured in a locked cabinet when not in use or being updated. 
19.2 Access to Participants: 
Access to EPIC will be required to collect data relevant to the study. The 
participant giving consent to participate in this study will also give permission for 
the research team to use intraoperative anesthesia data for the study. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury:  
In the event that this research activity results in an injury, treatment will be 
available, including first aid, emergency treatment and follow-up care as needed. 
Care for such injuries will be billed in the ordinary manner, to you or your 
insurance company. If you think that you have suffered a research related injury 
let the study physicians know right away.   
20.2 Contract Language: N/A 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained): 
Consent will occur prior to surgery. While it is ideal to consent the patient in the 
days prior to surgery, it is not feasible for the anesthesiology department to find 
potential participants in advance as organs have to be matched with appropriate 

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patients and therefore patients do not know when they will be having surgery.  It 
cannot be scheduled until an organ becomes available.  
Patients will be approached in the preoperative holding room the day of surgery. 
The research team will be in close communication with the clinical care team in 
the pre-op area so as to not disrupt clinical workflow. The research team will take 
extra precautions to carefully review of all elements of the ICF with participant, 
answer questions, verify understanding and give them time to think about or 
discuss participation and receive signed copy of ICF.  
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained): N/A 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained): N/A  
21.4 Non-English Speaking Participants: Patients with any primary language will be 
considered for inclusion when a professional interpreter is available for the 
consent process and other aspects of the study. The study does not target 
participants with any specific language. A short form, if available, will be used if 
the subject is non-English speaking. Both the participant and the translator will 
sign the informed consent. The translator will sign in the witness block.  
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): N/A 
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent:  
The Anesthesia research team recognizes that consenting patients the day of the 
surgery increases the vulnerability of the patient. If a potential participant is 
approached to participate in the study in the pre-op holding area, the research 
team will take extra precautions to carefully review of all elements of the ICF with 
participant, answer questions, verify understanding and give them time to think 
about and/or discuss participation. Patients who are noticeably stressed or upset 
will not be approached for this study.  
21.7 Adults Unable to Consent: 
• Permission: N/A 
• Assent: N/A 
• Dissent: N/A 
22.0 Setting 
22.1 Research Sites:  
• The primary research site will be East Bank campus of the University of 
Minnesota – Twin Cities, and the University of Minnesota Health/Fairview East 
Bank hospital. The surgeries will be performed at the hospital. 

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• Data analysis will be conducted within the anesthesiology department in the 
Mayo building on the campus of the University of Minnesota and at the 
University of Minnesota Health/Fairview East Bank hospital 
22.2 International Research: N/A 
23.0 Multi-Site Research: N/A 
24.0 Coordinating Center Research 
24.1 Role: N/A 
24.2 Responsibilities: N/A 
24.3 Oversight: N/A 
24.4 Collection and Management of Data: N/A 
25.0 Resources Available: 
Research Assistants to aid in consent and data acquisition. RA’s will also be responsible 
for bringing the hotdog blanket to the OR 
CRNAs will be trained by PI/Sub-PI on device setup and device monitoring. CRNA will 
monitor patient temperature throughout the procedure and 1 hour post op.  
Available Patients: On a typical week at the East Bank Medical Center, approximately 3-
4 potential participants undergo renal transplant, however, research staff availability to 
business hours will likely limit the number of enrolled participants 
Time to Devote:  List approximate time available to faculty and RAs (as percent effort). 
10-20% effort 
Describe your facilities:  
All procedures and surgeries will be performed in the clinical facilities of 
MHealth/Fairview East Bank. Data storage and analysis can be done using UMN BOX 
which is available in the Research Office. The research team is located on the 5th floor 
of the Mayo building. Documents will be kept in a locked cabinet in the research office.  
Describe your process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their duties and 
functions:  
RAs and other support faculty will be trained by the principle investigator and Co-PIs. 
Training will include a review of the protocol, consent form and data collection forms 
as well as hands-on instructions on the used devices and how to position the patient in 
the OR. Individuals who are familiar with the study protocol will be available in the OR 
to assist with participant positioning and optimization of heating system placement for 
the study 
26.0 References 

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1. Madrid E, Urrutia G, Roqué i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, 
Maestre L, Alonso-Coello P. Active body surface warming systems for preventing 
complications caused by inadvertent perioperative hypothermia in adults. Cochrane 
Database of Systematic Reviews. 2016. Apr;14(4). 
2. Sessler, D. Complications and treatment of mild hypothermia. Anesthesiology. 2001. 
95(2):531-543 
3. Sessler, D. Perioperative thermoregulation and heat balance. Lancet. 2016 
387(10038):2655-2664 
4. Russell SH, Freeman JW. Prevention of hypothermia during orthotopic liver 
transplantation: comparison of three different intraoperative warming methods. Br J 
Anaesth. 1995 Apr;74(4):415-8. 
5. John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive 
heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J 
Anaesth. 2016 Feb;116(2):249-54. 
6. Gosling AF, Rohrer B, Penick E, Zimmermann A, Johnson D, Naseem T, Ianchulev S, Cobey 
FC. Comparison of Forced-Air and Warm Circulating-Water Warming for Prevention of 
Hypothermia and Blood Product Utilization During Open Cardiac Surgery. J Cardiothorac 
Vasc Anesth. 2019 May 4. 
7. Wang M, Singh A, Qureshi H, Leone A, Mascha EJ, Sessler DI. Optimal Depth for 
Nasopharyngeal Temperature Probe Positioning. Anesth Analg. 2016 May;122(5):1434-8 
8. Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-
resolution time-synchronised physiological data from multiple anaesthesia devices. Sci 
Rep. 2018 8(1):1527