Assessment of Sous Vide Water Baths for Acute Rewarming of Frostbitten Extremities
Phase: NA
Conditions: Frostbite, Frostbite of Hand, Frostbite of Foot
Sponsor: Dartmouth-Hitchcock Medical Center

 
Study Title: Assessment of Sous Vide Water Baths in the Acute 
Rewarming of Frostbitten Extremities: A Multicenter Study Document  
 
Date: 1/17/2023 
 
NCT #: 05280301 
 

 
 
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D-HH IRB OVERSIGHT: 
One of the following must be true in order to submit to the D-HH IRB. Please check all 
that apply: 
 
☒ The Principal Investigator is employed by D-H 
☒ The study will utilize any D-H data or specimens 
☒ The study will enroll D-H patients or recruit from D-H sites 
☒ The study will utilize any D-H resources, e.g. study procedures will occur at  
     D-H locations and/or use of D-H equipment or shared resources 
 
PROTOCOL TITLE: 
Assessment of Sous Vide Water Baths for Acute Rewarming of Frostbitten Extremities 
 
PRINCIPAL INVESTIGATOR: 
Nicholas Daniel, DO 
Department of Emergency Medicine 
651-216-4893 
Nicholas.Daniel@hitchcock.org 
VERSION NUMBER/DATE: 
Version 2, 11/25/22 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
11/25/2022 
Addition of subject follow up and chart review 
at 6 months 
Yes, 
reconsent 
required 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ................................................................ 5 
6.0 
Procedures Involved*............................................................................................... 6 
7.0 
Data and Specimen Banking* ................................................................................ 11 
8.0 
Sharing of Results with Subjects* ......................................................................... 11 
9.0 
Study Timelines* ................................................................................................... 11 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 12 
11.0 Vulnerable Populations* ........................................................................................ 12 
12.0 Local Number of Subjects ..................................................................................... 12 
13.0 Recruitment Methods ............................................................................................. 13 
14.0 Withdrawal of Subjects* ........................................................................................ 13 
15.0 Risks to Subjects* .................................................................................................. 14 
16.0 Potential Benefits to Subjects* .............................................................................. 16 
17.0 Data Management* and Confidentiality ................................................................ 16 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 18 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
20.0 Compensation for Research-Related Injury ............ Error! Bookmark not defined. 
21.0 Economic Burden to Subjects ................................................................................ 20 
22.0 Consent Process ..................................................................................................... 20 
23.0 Process to Document Consent in Writing .............................................................. 22 
24.0 Setting .................................................................................................................... 23 
25.0 Resources Available............................................................................................... 24 
26.0 Multi-Site Research* .............................................. Error! Bookmark not defined. 
 
 
 

 
 
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1.0 
Study Summary 
Study Title 
Assessment of Sous Vide Water Baths for Acute Rewarming of 
Frostbitten Extremities 
Study Design 
Patients with acutely frostbitten hands or feet presenting to the 
emergency department will be consented to participate in the 
study.  An ANOVA sous vide device will be attached to a water 
basin and set at 38oC.  Two thermometers will continuously 
monitor water bath temperatures and the readings from the 
thermometers and sous vide device will be recorded every two 
minutes.  The frostbitten extremity will remain in the circulating 
warm water bath for 30 minutes, at which time the extremity will 
be evaluated to see if rewarming is complete (warm to touch, 
pliable tissue). Tissue that is still frozen will be placed back into 
the water bath for an additional 30 minutes, at which time they will 
be reassessed.  Medical providers directly involved in the care of 
the patient will fill out a survey regarding viability of this method 
and ease of use.  
Primary Objective 
To assess the ability of sous vide rewarming in maintaining 
constant water bath temperatures and efficacy in rewarming the 
acutely frostbitten extremity. 
Secondary 
Objective(s) 
To determine the ease of use of sous vide water bath rewarming in 
the acutely frostbitten extremity.  
Research 
Intervention(s)/ 
Invest. Agent(s)  
ANOVA Precision® Cooker sous vide device 
IND/IDE #  
NA 
Study Population 
Patients presenting to the emergency department with acute 
frostbite requiring rewarming; 
Providers to conduct rewarming, and complete a survey 
Sample Size 
1-5 patients locally, with anticipation of multicenter collaboration 
at 5-10 additional locations with similar enrollment goals.  
Study Duration for 
individual 
participants 
1-2 hours 
Study Specific 
Abbreviations/ 
Definitions  
SVD – sous vide device, SVR – sous vide rewarming 
 
 

 
 
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2.0 
Objectives* 
• 
The purpose of the study will be to describe the use of a sous vide 
cooking device (SVD) in heating a water bath for the acute treatment 
of frostbite in the emergency department (ED).  
• 
The aims will be to use this device in the treatment of an estimated 
5-20 cases of acute frostbite in the ED, across a multicenter 
collaboration. The specific aims will be to assess the ability of the 
device to reach and maintain a target water temperature, and to 
survey those involved in the management of the patient regarding 
ease of use of this modality.   
• 
Based on pilot study preliminary data, we hypothesize that the SVD 
will rapidly heat a small water bath, maintain the target temperature, 
and be considered easy to use.  
3.0 
Background* 
• 
Frostbite is a clinical entity in which extremities, digits, and 
appendages undergo freezing damage due to  exposure to 
environmental cold. Once in a safe environment where the potential 
for re-freezing is minimal, the current standard of care for acute 
frostbite is the rapid rewarming of the affected body part, using a 
circulating warm water bath targeted to 37-39oC. There is no current 
“best” modality to warm and circulate the water.  Depending on 
resources, this may be difficult and time consuming.  In the field, 
water can be heated over a fire and added to a water bath. If heated 
water is present, hot tap water can be incrementally added to a water 
bath to achieve and maintain the targeted temperature.  In the ED, 
some have advocated for placing the frostbitten hand or foot in a 
sink with running hot water and a thermometer in the sink to detect 
temperature. These methods are difficult at best, and may be 
dangerous in that they either do not maintain the water at the 
targeted temperature, or burn the frostbitten and often insensate 
extremity.  An inexpensive, small, and transportable device that 
could reliably heat and circulate the water would decrease provider 
effort and optimize the water bath to the targeted temperature range.  
In remote locations where electricity is present but not reliably hot 
water, a portable heating device would drastically improve care.  
• 
This modality is novel, and to our knowledge, has only been used 
clinically by our research group. In early 2020, a study was 
published investigating the in vitro use of SVDs in creating 

 
 
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circulating warm water baths for the rewarming of frozen pigs’ feet. 
In this study, the SVD maintained the water bath at a constant 40oC 
for 30 minutes and resulted in the rewarming of the pig foot from 
frozen to pliable.  The sous vide modality was compared against and 
outperformed manual water exchanges. To test this clinically, we 
completed a pilot study in 2021 and successfully treated acute 
frostbite in the ED. 
• 
Daniel NJ, Storn JM, Elder JH, Chevalier JI, Weinberg NE. Clinical 
Utilization of a Sous Vide Device in the Acute Rewarming of 
Frostbitten Extremities. Am J Emerg Med. 2021. DOI: 
https://doi.org/10.1016/j.ajem.2021.12.026 
• 
Fiutko A, Foreman C, Mycyk M, Weber J. A novel approach to 
rapid rewarming of a frostbitten extremity: The sous vide method. 
Am J Emerg Med. 2020;38(3):463-465. 
• 
This study will expand on the first documented use of sous vide 
rewarming (SVR) in the clinical setting and support proof of 
concept. Increased patient numbers will demonstrate the efficacy of 
using this method will provide the foundation for further study of 
SVR as a rapid, reliable, and portable modality for treating acute 
frostbite. 
4.0 
Study Endpoints* 
• 
The primary study endpoint will be the rewarming of frostbitten 
extremities for 30 minutes at 38oC.  
• 
The secondary study endpoint will be a survey regarding ease of use 
of this rewarming modality.  
• 
The primary safety endpoint will be patient pain or discomfort that is 
determined to be unrelated to the discomfort known to be associated 
with rewarming frostbitten tissue. Two consecutive temperature 
measurements above 42oC will prompt the cessation of the SVR. 
5.0 
Study Intervention/Investigational Agent 
1.1 Description: The intervention will be the use of a sous vide device to 
heat the water bath to 38oC, rather than the traditional methods of 
manual water exchanges or placing the frostbitten tissue under 
running water. 
• 
Drug/Device Handling: The SVD will be stored in a Tupperware 
container and appropriately labeled.  The container will be stored in 

 
 
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a locked supply closet and only accessible by providers.  This device 
is not used for other purposes in the ED, however signs on the 
container will read that this device is to be used only for this study.  
• 
Cleaning the SVD:  
• A sign up chart will be taped to the container housing the 
SVD.  The user will record the date of use, and upon 
returning the SVD to the container, will check a column 
indicating that they have sanitized the SVD with Purple 
SaniWipe cloths and a protocolized dishwasher detergent 
run. 
6.0 
Procedures Involved* 
• 
Patients presenting to the ED at Dartmouth-Hitchcock and external 
study sites with acute frostbite (tissue still frozen) of the hands 
and/or feet will be identified and approached for recruitment. 
Patients not entering the study will continue to be treated by ED 
providers in the traditional fashion.  
• 
Patients recruited for the SVR study will be consented to have their 
circulating warm water bath(s) heated by the novel SVR method. 
Providers or nurses caring for the study subjects will be consented to 
participate and will 1) conduct the SVR procedure, and 2) complete 
a questionnaire. A researcher will gather SVR equipment and attach 
two thermometers on the basin: one on the side nearest the SVD, the 
other on the opposite side. The researcher will verbally walk the 
provider or nurse carrying out the SVR through the following steps. 
A 15 L Sterilite® basin will be filled to the marked line (12cm) with 
water from jugs at room temperature, for each frozen extremity. One 
extremity can be rewarmed in a single basin, with the possibility for 
up to four simultaneous SVR basins for a patient with frostbite of all 
hands and feet. The SVD will be attached to the distal edge of the 
basin, with one SVD per rewarming basin.  The SVD will be turned 
on and set to maintain the bath at a constant 38oC for 30 minutes 
duration. The thermometers will be powered on continuously and the 
researcher will record temperatures simultaneously from each 
thermometer and the SVD every 2 minutes. At the end of the 30 
minute treatment, the extremity will be assessed by the researcher for 
warmth and pliability.  If the extremity still feels cold or frozen, an 
additional 30 minutes in the water bath will commence, with 

 
 
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subsequent reassessment. Rewarming will be considered complete 
when the affected tissue becomes red or purple, soft, and pliable.   
• 
Patients who do not consent to SVR and elect for traditional water 
bath management will be asked for their consent to record the similar  
demographic, water temperature, and time-to-rewarm data as in the 
SVR treatment arm. After re-warming is complete, the provider will 
be asked to fill out a survey regarding the ease of use and efficacy of 
the SVR. 
• 
Describe: 
• 
Procedures performed to lessen the probability or magnitude 
of risks. 
o Dual thermometers will record water bath 
temperature to assess for the possibility of 
disequilibrium in water temperature and to detect 
possible hot spots.  
o The treatment will be terminated if two consecutive 
thermometer recordings detect water temperatures 
of 42oC or above.   
o The rewarming process in acute frostbite is 
inherently painful. Pain increases when water bath 
temps are above 40oC. No additional discomfort is 
expected beyond that for frostbite rewarming, at the 
target temperature of 38oC. The provider can 
provide analgesia as indicated. The treatment will 
be terminated if the patient has discomfort that is 
deemed by the treating provider to be  above that 
expected from rewarming frozen tissue. 
o If treatment is discontinued prior to successful 
rewarming, standard rewarming will occur.   
• 
Explain if any part of this study involves the use of procedures 
that are inconsistent with the standard of care at Dartmouth-
Hitchcock Medical Center.  
o There are no parts of the study that are inconsistent 
with the standard of care at DHMC. The novel 
treatment is to assess a treatment modality that may 
elevate the standard of care. 
• 
All drugs and devices used in the research and the purpose of 
their use, and their regulatory approval status. 

 
 
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• The ANOVA Precision® Cooker is a purpose-built device 
to maintain a set temperature circulating water bath. The 
device is not FDA approved for medical use. There will be 
no use of a placebo.  
• The study treatment takes place entirely in the ED, which 
allows for comprehensive assessment of protocol 
compliance. If a subjects opts to discontinue participation 
at any time during the rewarming, standard techniques for 
maintaining the water bath will replace the SVD. 
• 
Describe randomization: 
o All patients presenting with acutely frostbitten 
hands or feet will be approached for inclusion in the 
study. There is no randomization. Any patient not 
consenting to the use of the SVD but willing to 
allow data collection will act as a control group.  
• 
Prior and Concomitant Therapy: 
o Concomitant therapies, such as intravenous fluids, 
anti-emetics, forced air warming blanket, and 
analgesia, as well as other medications deemed 
necessary by the provider, may be given 
concomitantly during the treatment period.  
o The blood pressure cuff used in the standard 
emergency department assessment of vital signs 
will be placed on an extremity that is not currently 
being rewarmed, whenever possible, to avoid 
constricting blood flow to the affected tissue.  
• 
Data Collection: 
o Prior to rewarming, physical examination of the 
patient, including the frozen extremity, will be 
completed and documented in the EPIC/EMR chart 
by the provider.  
o Two thermometers, placed in the rewarming basin, 
will continuously monitor the water temperature.  
The temperature reading on both thermometers as 
well as the SVD will be recorded on a paper data 
sheet by a trained provider at 2-minute intervals 
until the 30 minutes of treatment are complete.  

 
 
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o The researcher will repeat an exam, assessing all 
extremities being treated by SVR, at 30 minutes to 
determine warmth and pliability of the tissue, 
confirming thaw.  Rewarming will be considered 
complete if the affected tissue becomes red or 
purple, soft, and pliable.  The same rewarming 
criteria applies for all extremities.  
o The provider will be asked to fill out a survey on all 
acute frostbite patients whom consent to the study 
protocol, as well as those that do not.  
• 
The source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection 
forms.)If there are plans for long-term follow-up (once all 
research related procedures are complete), what data will be 
collected during this period.  
o The patient’s age and sex will be recorded. The 
physical examination and pertinent medical 
information will be reviewed to confirm the 
location and extent of the frostbite and for 
contributing conditions.  
o Demographics and relevant medical history will be 
accessed.  
o Please see attached surveys and data collection 
forms. 
o Enrolled subjects may be contacted via phone and 
myDH or local electronic medical record 
communication at 6 months post-enrollment to 
assess long term outcomes of their frostbite.  Chart 
review to assess related complications will also 
occur at this time.  
 
 
• 
Explain if any part of this study involves genetic analysis of 
biological specimens. If yes, explain whether the study is based 
on one the following: 
o This study does not involve genetic analysis of 
biological specimens.  
Provider Participation: 
• 
Role/Activities: 

 
 
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o Providers assigned to a patient in the emergency 
department who is determined to have acute 
frostbite will be targeted.  
o The provider’s role will be to identify an acute 
frostbite patient and ask their patient whether they 
would be interested in hearing more about and 
potentially participating in a study assessing a new 
way to rewarm their frostbitten tissue.  
o If the patient agrees, the provider access the study 
on-call investigator list (posted in the ED provider 
area) and inform a researcher of the patient and 
need to discuss the stud and potentially enroll the 
patient.  
• 
Recruitment: 
o Providers assigned to a patient in the emergency 
department who is determined to have acute 
frostbite. 
• 
Eligibility: 
o Any provider managing a frostbite patient at the 
training levels of PA, APRN, resident physician, 
fellow, or attending physician are eligible. 
• 
Consent Process: 
o One the patient has consented to participate, the 
provider will be consented in an area of the 
emergency department separate from the patient’s 
room, using the provider consent form. 
• 
Risks/Benefits: 
o Risks to providers should be minimal. We do not 
anticipate providers having any difficulty with 
voluntary decision-making for this study. 
o Benefits to the provider may include improved 
work flow due to the decreased labor in maintaining 
a SVR water bath in comparison to manual water 
bath management. Additionally, participation will 
provide a firsthand opportunity to treat acute 
frostbite with a new modality that has potential for 
increased use in the future.  
• 
Data Collection: 
o After successful completion of the SVR, providers 
will be asked to take a short, 6-question paper 
survey regarding ease-of-use of the SVR. 

 
 
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o Paper data collection forms will be kept in a locked 
office until transferred by the PI to a Microsoft 
excel file on a password-protected DH computer.   
 
 
 
 
7.0 
Data and Specimen Banking* 
• 
There will be no specimens banked for future use.  
• 
Individual patient data from the emergency department visit will 
exist in the patient’s EMR.  
• 
A de-identified, numerically listed spreadsheet of the study 
participants will be stored on the protected Dartmouth-Hitchcock H: 
drive of the PI. The participant key will exist on the same drive.  The 
PI computer is a D-H managed ThinkPad and will remain on-campus 
in a locked office shared by the PI. 
• 
Consented subjects will be tracked in the DHH CTMS, OnCore 
8.0 
Sharing of Results with Subjects* 
• 
Neither the individual subject or study results will be shared directly 
with the subjects or others, including the subject’s primary 
physician. The study results will be shared via publication.  
9.0 
Study Timelines* 
• 
Describe: 
• 
Each participant will be enrolled during the study period for 
this treatment, which includes the emergency department visit.  
The actual estimated treatment duration is 30 minutes.  Some 
participants may exceed this and be treated for 60-90 minutes.  
• 
Given the incidence of frostbite and census of the Dartmouth-
Hitchcock emergency department, and the requirement for the 
participant to have acute frostbite (currently frozen) rather than 
already thawed, it is expected to take the entire cold frostbite 
season to enroll 1-5 participants per study enrollment location. 
• 
The estimated date for the investigators to complete this study: 
Sept 11, 2023. 

 
 
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10.0 Inclusion and Exclusion Criteria* 
• 
The primary and sub-investigators will identify patients presenting to 
the emergency department with a chief complaint of frostbite, as 
seen on the EMR patient tracking board.  Reminder signs and group 
awareness in the emergency department of this study will help alert 
providers of the potential to approach subjects for enrollment who 
presented to the department with an associated complaint, such as 
“foot pain” or other chief complaint, but determined to have acute 
frostbite on initial examination. The PI or a Sub-I will be on-call to 
drive to the ED to enroll and consent the patient with the standard 
forms, and assist with the treatment. Consent will always be obtained 
in-person, by a study team member with consenting privileges. 
Inclusion criteria: Age 18 or up or <17 with parent or guardian able 
to provide consent, ability to understand English and provide consent 
to the study, acute frostbite (frozen tissue) of the hands or feet.  
• 
Exclusion criteria: Children under age 18 without parent or 
guardian, frostbite that has already thawed, frostbite (thawed or 
acute) of tissue other than hands or feet, inability to understand 
English and to provide consent.  
• 
Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the 
above populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 
• 
Adults unable to consent - Exclude 
• 
Individuals who are not yet adults (infants, children, teenagers) 
- Include 
• 
Pregnant women - Include 
• Prisoners - Exclude 
11.0 Vulnerable Populations* 
• 
This study presents no more than minimal risk to enrollees. There is 
no expected increase in risk to children or pregnant women over 
standard care treatment options. Excluding these populations may 
limit the sample size of the study.  
12.0 Local Number of Subjects 

 
 
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• 
The maximum available to enroll will be enrolled during the study 
period.  The investigators estimate 1-5 patients per study location 
may be feasible during the cold season.  
Describe the statistical methods for determining the sample size for the 
study 
- 
N/A. As a feasibility study to the use of SVR for acute frostbite, there 
are no sample size calculations. All potential participants will be 
approached for enrollment.  
13.0 Recruitment Methods  
• 
Patients presenting with acute frostbite in the Dartmouth-Hitchcock 
Emergency Department and participating centers and whom have 
expressed interest in participating in the study to their care team will 
be approached for recruitment during their emergency department 
visit.  
• 
Patients will be identified by the PI, Sub-Is, and other providers by 
the chief complaint, which may state frostbite, cold-injury, or pain in 
an extremity. Word-of-mouth and departmental awareness of this 
study will assist providers in identifying the appropriateness of 
recruiting patients that had varying other chief complaints, but found 
to have acute frostbite on evaluation.   
• 
Subjects will be recruited in person, during their emergency 
department visit and will be consented by the research team.  
• 
There will be no payments for participation in this study.  
• 
Some participating sites will request a Partial HIPAA Waiver of 
Authorization for Recruitment Purposes so that the research team 
can scan the emergency department electronic medical records board 
for patients presenting with frostbite. It is critical that the SVR is 
implemented quickly, which allows for the best treatment efficacy. 
By scanning the emergency department board, the research staff will 
more rapidly identify frostbite patients and circumvent possible 
delays in enrollment and treatment.  
 
14.0 Withdrawal of Subjects* 
• 
Subjects will be withdrawn without their consent for safety reasons 
or medical necessity. Criteria as follows: If water bath temperatures 
are recorded at over 42oC on two consecutive readings during the 

 
 
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same treatment phase, if subject is judged by the treating clinician to 
have pain greater than expected for frostbite rewarming, or if a 
separate medical issue arises in the subject in which urgent treatment 
necessitates termination of the research.  
• 
Describe any procedures for orderly termination. 
• The SVD will be powered off and the water bath 
maintained manually by medical staff.  
• 
Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
• Withdrawal from the research will preclude any further 
data collection.  Data already collected at the time of the 
withdrawal will be analyzed with other study data but noted 
that the study terminated prematurely.  
15.0 Risks to Subjects* 
• 
List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. 
• The standard of care for acute frostbite rewarming, which is 
a circulating warm water bath, will not be altered and 
patients will receive the standard of care treatment.  The 
only alteration is the method of maintaining the warm 
water bath. Frostbite rewarming is known to be a painful 
process.  Pain control will be at the discretion of the 
treating physician and the study will have no implications 
on this aspect of care.  
• Potential hazards include hot water burns and the unlikely 
chance of catastrophic device failure and electrical injury. 
There were no adverse events reported during the pilot 
study. Hot water burns are also a risk in the current practice 
of manual hot water bath management, and the SVD may 
actually mitigate this risk by improved temperature control.  
Biomedical engineering at Dartmouth-Hitchcock has 
assessed the ANOVA SVD. 

 
 
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• The investigators do not see any specific psychological, 
social, or economic risks to the subjects directly related to 
the research, as the circulating water bath rewarming 
method is the standard of care for frostbite management.   
If applicable, explain how the use of the placebo or non-standard of care therapy 
may affect risks for participants, addressing the following: 
• 
The safety and efficacy of other available therapies 
o The current available therapy for frostbite 
rewarming is the same as being used in this study – 
circulating warm water bath.  The study will use a 
new technique to creating this water bath. SVR is 
expected to be more efficacious than the current 
method of water bath management.  
• 
The greatest potential harm that may result from not receiving 
or delaying effective therapy 
o While unlikely, it is possible that the SVR would 
not heat the water and delay time to the current 
practice of manual water bath management. If this 
were to occur, delay to therapy would be minimal as 
the only change in intervention would be the 
manual addition of warm water to the basin.  It is 
expected that the research treatment will speed up 
the delivery of effective therapy.  
o Risk will be minimized by assessing the water 
temperature continuously. The SVR will be ceased 
and the manual rewarming started if the water bath 
does not reach the target temperature in 30 minutes, 
or if the water bath temperature drops below 37oC 
for more than 5 minutes. 
o If providers are unable to reach an on-call 
investigator and determine their availability within 
20 minutes from the patient expressing interest in 
the study, standard rewarming will proceed via 
traditional water exchange practices. 
• 
If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
• Unforeseeable risks different than typical water bath 
rewarming, if any, would relate to SVD failure. To further 
minimize this unlikely event the SVD will be physically 
checked for any signs of wear following each utilization at 

 
 
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the time of cleaning. The SVD has been assessed by 
biomedical engineering at Dartmouth-Hitchcock and 
deemed low risk.  
16.0 Potential Benefits to Subjects* 
• 
Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
• The current method of creating and maintaining a 
circulating warm water bath is arduous, time consuming, 
and not controlled.  It is highly suspected that the research 
method of water bath management will be quicker to 
achieve target water temperatures, safer in that the water 
temperature will be electronically monitored and 
maintained, and will benefit the patient in the expedited 
thawing of the frozen tissue.   
17.0 Data Management* and Confidentiality 
• 
Describe the data analysis plan, including any statistical procedures 
or power analysis. 
• The primary outcomes are whether or not the tissue 
rewarmed and the ability of the SVD to maintain accurate 
target water temperature. Descriptive statistics will be 
performed to describe the patient population, time to 
rewarm, and the provider assessment of ease of use.  
• 
Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
• Paper data collection forms will be kept in a locked office 
until transferred by the PI to a Microsoft excel file on a 
password-protected computer.  The identifiers and data will 
be contained in two separate files.  Only the PI and sub-
investigators will have access to the de-identified data and 
the PI will retain sole access to the identification key.   
• Data from other sites will be uploaded directly into 
REDCap database hosted by DHMC to ensure secure data 
transfer for multicenter analysis. Access to the data on the 

 
 
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REDCap database will be restricted to the PI and DHMC 
study staff.   
• Summarize the record retention plan applicable to the study (taking into 
account any applicable Dartmouth Department, Division or Research 
Center requirements, or applicable funding sponsor requirements.)  
• Records will be stored on-site on the PI’s password 
protected computer for 3 years after publication. 
• 
Describe any procedures that will be used for quality control of 
collected data. 
• Dual thermometers will act as redundant sampling of water 
bath temperatures 
• 
Describe how data or specimens will be handled study-wide: 
• 
What information will be included in that data or associated 
with the specimens? 
o The data collection form will include the MRN of 
the patient and a numeral used to de-identify the 
data in the excel file.  The collection form will 
contain a table of recorded water temperatures, 
including a temperature from each of the two 
thermometers as well as the SVD every 2 minutes 
during the rewarming period.  Any adverse events 
will also be recorded.  
• 
Where and how data or specimens will be stored? 
o Data collection forms filled out by clinicians or 
investigators will be stored in a locked office until 
the data is transferred to a Microsoft excel file. The 
data file will be stored on the password-protected 
computer of the PI.  
• 
How long the data or specimens will be stored? 
o Data will be stored throughout the duration of the 
study and manuscript preparation. 
• 
Who will have access to the data or specimens? 
o The data collection forms will be accessible to the 
clinician filling it out.  Once transferred to excel 
format, only the PI and sub-investigators will have 
access to the de-identified data.  Only the PI and 
key study personnel will have access to the de-
identification number key.  

 
 
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• 
Who is responsible for receipt or transmission of the data or 
specimens? 
o Data collection forms will be deposited in the 
locked office by the clinician or investigator filling 
out the form during active rewarming of a subject. 
o Data will be entered into REDCap for further 
analysis.  
o External sites will enter their data directly into the 
DH REDCap Database 
• 
How data or specimens will be transported? 
o Data will remain on the password protected hard 
drive of the PI.  
o Deidentified data may be analyzed by additional 
research team members.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
• 
Describe: 
• 
The plan to periodically evaluate the data collected regarding 
both harms and benefits to determine whether subjects remain 
safe.  The plan might include establishing a data monitoring 
committee and a plan for reporting data monitoring committee 
findings to the IRB and the sponsor. 
o The data will be reviewed by the local PI each time 
a subject participates in the study, to confirm 
standard process and to assess for reported adverse 
events.  
o As the lead site, we will review all data entered into 
the database for completeness.  
• 
What data are reviewed, including safety data, untoward 
events, and efficacy data. 
o Signed informed consent, temperature recordings, 
water bath treatment time required to achieve 
rewarming, and adverse events will be reviewed.  
• 
How the safety information will be collected (e.g., with case 
report forms, at study visits, by telephone calls with 
participants). 
o Adverse events will be recorded on the data 
collection form during the treatment of the subject 
in the emergency department.  

 
 
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o Adverse events across all sites will be reviewed at a 
monthly meeting of collaborating sites.  
• 
The frequency of data collection, including when safety data 
collection starts. 
o Data collection will commence when the subject is 
treated in the emergency department.  Data will be 
reviewed for safety issues after each subject.  
• 
Who will review the data. 
o The PI will review the safety data.  
• 
The frequency or periodicity of review of cumulative data. 
o The PI will review cumulative data after each 
subject. 
• 
The statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
o With an expected subject size of 1-5 study 
participants in each study location, safety data will 
be reviewed after each subject participates.  There 
will be no need to make estimations. 
• 
Any conditions that trigger an immediate suspension of the 
research. 
o If 1 or more unanticipated adverse events are 
considered possibly attributable to the use of the 
SVD, the study will be put on hold pending review 
of the incident. 
• 
Describe the procedures for unblinding study therapy on a 
subject, including documentation of this in the subject’s source 
document.  
o Unblinding study therapy will not be necessary, as 
the study is unblinded to the participant and the 
clinician treating the subject and the treatment will 
occur only during the rewarming phase in 
emergency department visit.  
19.0 Provisions to Protect the Privacy Interests of Subjects 
• 
Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 

 
 
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• Patients who may meet the enrollment criteria will be 
approached and asked if they are willing to learn about a 
research study taking place that they may qualify for. If the 
patient is not interested they will receive the current 
standard of care treatment. 
• 
Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
• Potential subjects will have the traditional method of 
rewarming explained as well as an explanation of how  
SVR works. They will be informed that research is 
voluntary and they can withdraw at any point. 
• 
Indicate how the research team is permitted to access any sources of 
information about the subjects. 
• The study team will be permitted to access the emergency 
department chart of the consented subjects to be able to 
record de-identified sex, age, frostbite location, further 
information about the case or any adverse event, and 
patient outcomes. The subject provides consent for this 
access as part of the informed consent process.  
20.0 Economic Burden to Subjects 
• 
Describe any costs that subjects may be responsible for because of 
participation in the research. 
• Hot water burns or electrical failure causing injury and the 
treatment of such injuries would be the only foreseeable 
costs incurred by the patient.  The burn risk is present in the 
traditional method of frostbite rewarming and the SVR is 
expected to minimize this risk.  Biomedical engineering at 
Dartmouth-Hitchcock has assessed the SVD, deemed it low 
risk, and cleared it for use. 
21.0 Consent Process 
• 
Indicate whether you will you be obtaining consent, and if so 
describe: 
• 
Where will the consent process take place 

 
 
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o Patient interest in study participation will be 
determined in the emergency department exam 
rooms (not the waiting room) by the provider. 
Patient consent will then be obtained in emergency 
department exam room by the investigator. 
o Upon patient consent, the researcher will approach 
the provider to obtain consent.  Provider consent 
will occur in the participating  emergency 
departments in a separate location outside of the 
patient’s exam room. The SVR will not proceed 
without patient consent, therefore, provider consent 
will be obtained only once patient consent has been 
obtained.  
• 
Any waiting period available between informing the 
prospective subject and obtaining the consent. 
o None. The prospective subject will be identified and 
consented at the earliest convenience as to avoid 
delaying emergency department rewarming. If 
providers are unable to reach an on-call investigator 
and determine their availability within 20 minutes 
from the patient expressing interest in the study, 
standard rewarming will proceed via traditional 
water exchange practices.  
• 
Any process to ensure ongoing consent. 
o Upon initial consent, the subject will be informed 
that they are able to withdraw from the study at any 
point during the rewarming period.  
• 
Whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
o SOP: Informed Consent Process for Research 
(HRP-090) will be followed. 
Non-English Speaking Subjects 
• 
Inability to understand and speak English are exclusion criteria 
for this study.   
Subjects who are not yet adults (infants, children, teenagers) 
• 
Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent 

 
 
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to treatments or procedures involved in the research under the 
applicable law of the jurisdiction in which the research will be 
conducted. (E.g., individuals under the age of 18 years.) 
• 
Describe whether parental permission will be obtained from: 
o 
One parent even if the other parent is alive, known, 
competent, reasonably available, and shares legal 
responsibility for the care and custody of the child. 
a. All subjects age 18 and overall will be asked 
to provide informed consent. 
b. All subjects ages 7-17 will be asked to 
provide assent in addition to consent of one 
parent or legal guardian. 
• 
All subjects ages 2-6 will be enrolled if consent of one parent 
or legal guardian is provided. Describe whether permission will 
be obtained from individuals other than parents, and if so, who 
will be allowed to provide permission. Describe the process 
used to determine these individuals’ authority to consent to 
each child’s general medical care. 
o If a parent or legal guardian is not present to 
provide consent, patients under age 18 will be 
excluded. 
• 
Indicate whether assent will be obtained from all, some, or 
none of the children. If assent will be obtained from some 
children, indicate which children will be required to assent. 
o Subjects age 7-17 will be asked to provide assent. 
o A prepared assent form using more simple 
language, but mirroring the adult consent, will be 
used as the basis to provide information to the 
subject aged 7-17 and for the assent process. 
o Subjects under age 7 will not be asked to provide 
assent. 
• 
When assent of children is obtained describe whether and how 
it will be documented. 
o Confirmation off assent will be recorded in the 
appropriate location on form HRP-502 and comply 
with SOP HRP-091 
22.0 Process to Document Consent in Writing 
This study will comply with SOP: Written Documentation of Consent 
(HRP-091) when the patient is physically able to sign the consent 
documentation.  

 
 
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We are requesting an alteration on the documentation of informed 
consent for subjects who are physically unable to sign. The consent 
process will remain unchanged from section 21.0 of this document, 
however given the enrolling population it is feasible if not expected that 
some potential subjects will present with bilateral frostbite of the hands 
and be physically unable to sign for themselves. 
In cases where the patient is unable to legibly initial, sign and date, due to 
injury to the hands, but is able to make a mark on the page, the patient 
will make a mark on/near the line for initials and the place for signature. 
A witness who is an impartial third party will observe consent discussion 
and the marking of the consent. The witness will acknowledge that they 
saw the subject make his mark on the specific date and then sign, print 
name, and date the witness section of the consent form.   
 
In instances where the patient is unable to make any mark on the consent 
form we will obtain and document verbal consent from the patient on the 
consent form and have an impartial third party serve as witness to the 
consent process. The person obtaining consent will sign and date the 
consent form. The witness will acknowledge that the informed consent 
was fully explained and the subject understood the study details. The 
witness will sign, print name, and date the witness section of the consent 
form. 
 
Only one consent form will be used for up to four extremities being 
treated for frostbite using the SVR rewarming process detailed in this 
document. 
 
23.0 Setting 
• 
Describe the sites or locations where your research team will 
conduct the research. 
• 
The research team will identify, recruit, and perform the study 
treatment in the Dartmouth-Hitchcock emergency department, 
which is a Level I Trauma center. The other study sites include 
the emergency departments at: TBD. All are Level I trauma 
centers, except for TBD, which is TBD.  
 

 
 
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24.0 Resources Available 
• This research study has the support of the emergency department chair. As 
PI, Dr. Daniel will dedicate as much time as necessary to oversee and 
ensure appropriate conduct of this study.  
• We are working with our Director of Research Operations to ensure 
compliance with institutional practice and appropriate regulatory 
management.  
• The Dartmouth-Hitchcock Emergency Department is an academic, level I 
Trauma center with an annual patient volume of approximately 35,000. 
The patient volume of other participating centers range from TBD to TBD. 
• The human research component is comprised of 30-90 minutes of 
treatment by placing hands and/or feet in a warm water bath.  As such, 
there is unlikely to be untoward medical or psychological consequences. 
Should medical or psychological consequences occur, the study is being 
completed in a Level I Trauma center emergency department that contains 
the resources to address any unforeseen issues.  
• All persons assisting with the research will undergo one-on-one training 
with the PI regarding the recruitment plan, consent process, and research 
procedures including monitoring, managing, and recording data on the 
participant and water bath, as well as protocols for cleaning and storing 
the SVD. A comprehensive email containing this information will be sent 
to all persons assisting as a reference.