Sous Vide Rewarming for Frostbitten Extremities

Frostbite Clinical Trial

Official title:

Clinical Utilization of Sous Vide Cooking Devices in the Acute Rewarming of Frostbitten Extremities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633174
• Other study ID #: D21002
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Frostbite
• Frostbite of Foot
• Frostbite of Hand

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 minutes
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	Up to 90 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.	Immediately after rewarming, up to 90 minutes