Frostbite, Frostbite of Foot, Frostbite of Hand
Conditions
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.
Interventions
DEVICESous 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Sous Vide Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Limbs That Can be Rewarming Within 30 Minutes
Assess if frostbitten extremities can be rewarmed in 30 minutes at 38 degrees celsius using the experimental device
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sous Vide Device | Number of Limbs That Can be Rewarming Within 30 Minutes | 2 limbs |
Primary
Time to Rewarm in Minutes
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sous Vide Device | Time to Rewarm in Minutes | 25 minutes |
Secondary
Ease of Use: Provider Review of the Investigational Device and Standard of Care
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Sous Vide Device | Ease of Use: Provider Review of the Investigational Device and Standard of Care | 1 units on a scale |
| Manual Water Bath Management | Ease of Use: Provider Review of the Investigational Device and Standard of Care | 3 units on a scale |