Clinical Utilization of Sous Vide Cooking Devices in the Acute Rewarming of Frostbitten Extremities
Phase: NA
Conditions: Frostbite, Frostbite of Hand, Frostbite of Foot
Sponsor: Dartmouth-Hitchcock Medical Center

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 1 of 20
v.05.31.2019
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:
Clinical Utilization of a Sous Vide Cooking Device in the 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 1, 8/14/20
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 2 of 20
v.05.31.2019
Table of Contents
1.0
Study Summary ........................................................................................................4
2.0
Objectives* ...............................................................................................................5
3.0
Background*.............................................................................................................5
4.0
Study Endpoints*......................................................................................................5
5.0
Study Intervention/Investigational Agent.................................................................5
6.0
Procedures Involved* ...............................................................................................7
7.0
Data and Specimen Banking*...................................................................................8
8.0
Sharing of Results with Subjects* ............................................................................9
9.0
Study Timelines*......................................................................................................9
10.0
Inclusion and Exclusion Criteria* ............................................................................9
11.0
Vulnerable Populations*...........................................................................................9
12.0
Local Number of Subjects ......................................................................................10
13.0
Recruitment Methods..............................................................................................10
14.0
Withdrawal of Subjects*.........................................................................................10
15.0
Risks to Subjects*...................................................................................................11
16.0
Potential Benefits to Subjects* ...............................................................................11
17.0
Data Management* and Confidentiality.................................................................11
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*.........................12
19.0
Provisions to Protect the Privacy Interests of Subjects ..........................................13
20.0
Compensation for Research-Related Injury............................................................14
21.0
Economic Burden to Subjects.................................................................................14
22.0
Consent Process......................................................................................................14
23.0
Process to Document Consent in Writing...............................................................17
24.0
Setting.....................................................................................................................17
25.0
Resources Available ...............................................................................................18
26.0
Multi-Site Research* ..............................................................................................18

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 3 of 20
v.05.31.2019
1.0
Study Summary
Study Title
Clinical Utilization of Sous Vide Cooking Devices in the 
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 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)/ 
Investigational 
Agent(s) 
ANOVA sous vide device
IND/IDE # 
NA
Study Population
Patients presenting to the emergency department with acute 
frostbite requiring rewarming
Sample Size
3-5 patients
Study Duration for 
individual 
participants
1-2 hours
Study Specific 
Abbreviations/ 
Definitions 
SVD – sous vide device, SVR – sous vide rewarming

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 4 of 20
v.05.31.2019
2.0
Objectives*

The purpose of the study will be to describe the use of a sous vide 
cooking device 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 3-5 cases of 
acute frostbite in the ED. 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.  

We hypothesize that the sous vide device 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 unintentional 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 hot water, a 
portable heating device would drastically improve care. 

This modality is novel and has not been used in the clinical setting, 
to our knowledge. In early 2020, a study was published investigating 
the in vitro use of sous vide devices in creating circulating warm 
water baths for the rewarming of frozen pigs feet. In this study, the 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 5 of 20
v.05.31.2019
sous vide device 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. 

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 be the first documented use of sous vide rewarming 
(SVR) in the clinical setting. Demonstration of 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 
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 dishwasher detergent run

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 6 of 20
v.05.31.2019
6.0
Procedures Involved*

Patients presenting to the ED at Dartmouth-Hitchcock with acute 
frostbite (tissue still frozen) of the hands 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. 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.  The 
sous vide device (SVD) will be attached to the distal edge of the 
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 every 2 minutes. At the end 
of the 30 minute treatment, the SVD will be powered off and the 
extremity 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 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. 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 7 of 20
v.05.31.2019
o
If more than 2 extremities require rewarming at any 
one point in a subject consenting to SVR, SVR will 
occur with two extremities and standard rewarming 
for extremities >2.
o
The treatment will be terminated if two consecutive 
thermometer recordings detect water temperatures 
of 42oC or above.  
o
The treatment will be terminated if the patient had 
discomfort deemed above that expected with the 
rewarming of frostbitten tissue. 

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.
There will be no use of a placebo. 

Describe randomization:
o
All patients presenting with acutely frostbitten 
hands or feet will be approached for inclusion in the 
study.

Prior and Concomitant Therapy:
o
Concomitant therapies, such as intravenous fluids, 
anti-emetics, 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 will be placed on an 
extremity that is not currently being rewarmed, 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 chart by the 
provider.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 8 of 20
v.05.31.2019
o
Two thermometers, placed in the rewarming basin, 
will continuously monitor the water temperature.  
The temperature reading on both thermometers will 
be recorded on a paper data sheet by a trained 
provider at 2-minute intervals until the 30 minutes 
of treatment are complete. 
o
The researcher will repeat an exam at 30 minutes to 
determine warmth and pliability of the tissue, 
confirming thaw. 
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.

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. 
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: 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 9 of 20
v.05.31.2019
drive of the PI. The participant key will exist on the same drive.  The 
PI laptop computer will remain on-campus in a locked office shared 
by the PI.

Consented subjects will be tracked in the DHH CTMS (currently 
Velos, transitioning to 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 3-5 participants.

The estimated date for the investigators to complete this study: 
Sept 1 1, 2022
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.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 10 of 20
v.05.31.2019

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*

If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare.

If the research involves pregnant women, review 
“CHECKLIST: Pregnant Women (HRP-412)” to ensure that 
you have provided sufficient information.
12.0
Local Number of Subjects

The maximum available to enroll will be enrolled during the study 
period.  The investigators estimate 3-5 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 whom have expressed interest in 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 11 of 20
v.05.31.2019
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 compliant, 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 Describe materials that will review 
consent form HRP-502.

There will be no payments for participation in this study. 
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, 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 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 12 of 20
v.05.31.2019
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.  
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.  
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.. 
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 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. 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 13 of 20
v.05.31.2019
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 25 minutes, 
or if the water bath temperature drops below 37oC 
for more than 5 minutes.

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. 
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.
This is a pilot feasibility study where the primary outcome 
is whether or not the tissue rewarmed and the time 
required. 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.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 14 of 20
v.05.31.2019
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.  
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 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 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 15 of 20
v.05.31.2019
format, only the PI and sub-investigators will have 
access to the de-identified data.  Only the PI will 
have access to the de-identification number key. 

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.

How data or specimens will be transported?
o
Data will remain on the password protected hard 
drive of the PI. 
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 PI each time a 
subject participates in the study, to confirm standard 
process and to assess for reported adverse events. 

What data are reviewed, including safety data, untoward 
events, and efficacy data.
o
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. 

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. 

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 16 of 20
v.05.31.2019

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 3-5 study 
participants in a single 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 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.
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.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 17 of 20
v.05.31.2019
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 PI will be permitted to access the emergency 
department chart of the subjects to be able to record de-
identified sex, age, frostbite location, further information 
about the case or any adverse event, and patient outcomes. 
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 has assessed 
the SVD.
21.0
Consent Process

Indicate whether you will you be obtaining consent, and if so 
describe:

Where will the consent process take place
o
Patient consent will be obtained in the Dartmouth-
Hitchcock Emergency Department in exam room 
space (not the waiting room)

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. 

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:

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 18 of 20
v.05.31.2019
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 
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
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.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 19 of 20
v.05.31.2019
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. 
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. The 
person obtaining consent will print and date for the participant. A witness 
who is not a member of the study team will observe the marking of the 
consent and sign, print 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 a non-study team member serve as witness to the 
consent process. The person obtaining consent will document in the area 
initial and signature areas that verbal consent was provided. The person 
obtaining consent will print the patient’s name and date for them in the 
appropriate areas of the consent.  The witness will sign and date the 
witness section of the consent form. 
 Only one consent form will be used even if two extremities are 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.

PROTOCOL TITLE: Clinical Utilization of a Sous Vide Device in the Acute 
Rewarming of Frostbitten Extremities
Page 20 of 20
v.05.31.2019

The research team will identify, recruit, and perform the study 
treatment in the Dartmouth-Hitchcock emergency department, 
which is a Level I Trauma center. 
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 a ROM 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 human research component is comprised of 30 minutes of treatment 
by placing hands 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.