Sous Vide Rewarming for Frostbitten Extremities

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04633174
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.

Condition or Disease	Intervention/Treatment	Phase
Frostbite; Frostbite of Hand; Frostbite of Foot	Device: Sous Vide Device (SVD)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Utilization of Sous Vide Cooking Devices in the Acute Rewarming of Frostbitten Extremities
• Actual Study Start Date: Jan 14, 2021
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Sous vide device 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.

Device: Sous Vide Device (SVD); A basin will be filled to the marked line 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 38 degrees celsius 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.

Outcome Measures

Primary Outcome Measures

1. Number of Limbs That Can be Rewarming Within 30 Minutes [30 minutes]

   Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device

2. Time to Rewarm in Minutes [Up to 90 minutes]

   Measure the time required to rewarm frostbitten extremities until the extremity is reddish or purple in coloration, and soft and pliable

Secondary Outcome Measures

1. Ease of Use: Provider Review of the Investigational Device and Standard of Care [Immediately after rewarming, up to 90 minutes]

   Providers will report ease of use of the rewarming modalities by completing a survey. The survey consists of two questions requesting providers to indicate ease of use of 1) the device and 2) Standard of care (manual water bath) on a scale from 1-10, where 1 indicates easy and 10 indicated difficult.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 or up

• Age <17 with parent or guardian consent

• Ability to understand English

• Ability to provide consent to the study

• Acute frostbite of the hands or feet

Exclusion Criteria:

• Children under age 18 without parent or guardian

• Frostbite that has already thawed

• Frostbite of tissue other than hands or feet

• Inability to understand English

• Inability to provide consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Nicholas Daniel, DO, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 14, 2020

More Information

Publications

None provided.

• Responsible Party: Nicholas Daniel, DO, Assistant Professor, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT04633174
• Other Study ID Numbers: D21002
• First Posted: Nov 18, 2020
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Frostbite

Study Results

Participant Flow

Arm/Group Title	Sous Vide Device
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sous Vide Device
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	1 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Number of Limbs That Can be Rewarming Within 30 Minutes
Description	Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sous Vide Device
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.
Measure Participants	1
Measure Limbs	2
Number [limbs]	2

2. Primary Outcome

Title	Time to Rewarm in Minutes
Description	Measure the time required to rewarm frostbitten extremities until the extremity is reddish or purple in coloration, and soft and pliable
Time Frame	Up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sous Vide Device
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.
Measure Participants	1
Measure Limbs	2
Mean (Full Range) [minutes]	25

3. Secondary Outcome

Title	Ease of Use: Provider Review of the Investigational Device and Standard of Care
Description	Providers will report ease of use of the rewarming modalities by completing a survey. The survey consists of two questions requesting providers to indicate ease of use of 1) the device and 2) Standard of care (manual water bath) on a scale from 1-10, where 1 indicates easy and 10 indicated difficult.
Time Frame	Immediately after rewarming, up to 90 minutes

Outcome Measure Data

Analysis Population Description

One care provided completed a single survey to on the ease of use of the investigational device and standard of care. The results below are the actual response on the survey.

Arm/Group Title	Sous Vide Device	Manual Water Bath Management
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.	Standard of care for rewarming of Frostbitten Extremities
Measure Participants	1	1
Measure Care Providers	1	1
Number [units on a scale]	1	3

Adverse Events

Time Frame	Adverse events were recorded during the extremity rewarming, up to 30 minutes.
Arm/Group Title	Sous Vide Device
Arm/Group 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. Sous Vide Device (SVD): A basin will be filled to the marked line 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 38 degrees celsius 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.
All Cause Mortality
	Sous Vide Device
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	Sous Vide Device
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Sous Vide Device
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

The recruitment period was limited to one winter season (Winter 2020-2021). During the recruitment period, only one patient was seen for frostbite.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.