Trial Outcomes & Findings for Sous Vide Rewarming for Frostbitten Extremities (NCT NCT04633174)
NCT ID: NCT04633174
Last Updated: 2021-09-28
Results Overview
Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
30 minutes
Results posted on
2021-09-28
Participant Flow
Unit of analysis: Limbs
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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1 2
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Overall Study
COMPLETED
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1 2
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sous Vide Rewarming for Frostbitten Extremities
Baseline characteristics by cohort
| Measure |
Sous Vide Device
n=1 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
|
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=93 Participants
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Age, Categorical
>=65 years
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0 Participants
n=93 Participants
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Sex: Female, Male
Female
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0 Participants
n=93 Participants
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Sex: Female, Male
Male
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1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 minutesAssess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device
Outcome measures
| Measure |
Sous Vide Device
n=2 Limbs
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.
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Manual Water Bath Management
Standard of care for rewarming of Frostbitten Extremities
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|---|---|---|
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Number of Limbs That Can be Rewarming Within 30 Minutes
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2 limbs
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—
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PRIMARY outcome
Timeframe: Up to 90 minutesMeasure the time required to rewarm frostbitten extremities until the extremity is reddish or purple in coloration, and soft and pliable
Outcome measures
| Measure |
Sous Vide Device
n=2 Limbs
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.
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Manual Water Bath Management
Standard of care for rewarming of Frostbitten Extremities
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|---|---|---|
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Time to Rewarm in Minutes
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25 minutes
Interval 24.0 to 26.0
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—
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SECONDARY outcome
Timeframe: Immediately after rewarming, up to 90 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Sous Vide Device
n=1 Care Providers
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.
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Manual Water Bath Management
n=1 Care Providers
Standard of care for rewarming of Frostbitten Extremities
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|---|---|---|
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Ease of Use: Provider Review of the Investigational Device and Standard of Care
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1 units on a scale
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3 units on a scale
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Adverse Events
Sous Vide Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nicholas Daniel, Staff Physician, Emergency Services
Dartmouth-Hitchcock Medical Center
Phone: (603) 650-7254
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place