跳至主要内容
临床试验/NCT05280301
NCT05280301已完成不适用

Assessment of Sous Vide Water Baths for Acute Rewarming of Frostbitten Extremities

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Rewarming

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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 and/or feet

排除标准

  • 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

结局指标

主要结局

Rewarming

时间窗: Up to 90 minutes

Assess if frostbitten extremities can be thawed in a warm water bath created by the experimental device.

Rewarming

时间窗: 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

时间窗: 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

次要结局

  • Ease of Use: Provider Review(Immediately after rewarming, up to 90 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Daniel, DO

Assistant Professor

Dartmouth-Hitchcock Medical Center

研究点 (2)

Loading locations...

相似试验

Multicenter Sous Vide Frostbite | 临床试验