Multicenter Sous Vide Frostbite
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 |
|---|---|---|
|
N/A |
Detailed Description
Frostbite can be a devastating and limb threatening injury. Treatment involves active rewarming in a warm water bath at a consistent temperature, but maintaining the correct temperature water is clinically challenging. Currently these water baths are created and monitored manually - leading to poor rewarming and inefficient use of resources. The "sous vide" device offers an alternative to the manual water bath method. The specific aim of our study is to evaluate the safety, efficacy, and feasibility of use of the sous vide device in patients with extremity frostbite in a multicenter prospective cohort. Data demonstrating the ability of the sous vide device to warm and precisely maintain water bath target temperatures, in addition to expanded evidence of the safety of this modality, will support the broader use of sous vide devices in frostbite care.
Study Design
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 38 degrees celsius, 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 and the SVD every 2 minutes. At the end of the 30 minute treatment, 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
- Rewarming [Up to 90 minutes]
Assess if frostbitten extremities can be thawed in a warm water bath created by 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 Outcome Measures
- Ease of Use: Provider review [Immediately after rewarming, up to 90 minutes]
Providers will report ease of use of the rewarming modality by completing a survey. The survey consists of two questions requesting providers to indicate ease of use of the device on a scale from 1-10, where 0 indicates easy and 10 indicated difficult.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or up
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Age <17 with parent or guardian consent
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Ability to understand English
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Ability to provide consent to the study
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Acute frostbite of the hands and/or feet
Exclusion Criteria:
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Children under age 18 without parent or guardian
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Frostbite that has already thawed
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Frostbite of tissue other than hands or feet
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Inability to understand English
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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)
None provided.More Information
Publications
None provided.- STUDY02001452