跳至主要内容
临床试验/NCT00715728
NCT00715728已完成不适用

Efficacy of a New Intraoperative Resistive Warming Device

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
The Rate of Core Rewarming Over the Range From 35°C to 37°C.

研究概览

简要总结

This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.

详细描述

Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Plastic surgery lasting approximately 5 hours
  • Subjects over the age of 18 years
  • Patient signed Informed Consent

排除标准

  • Plastic surgery lasting less than 5 hours
  • Individuals under the age of 18 years

结局指标

主要结局

The Rate of Core Rewarming Over the Range From 35°C to 37°C.

时间窗: Until the end of surgery, up to 5 hour

The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.

Intraoperative Time Weighted Average Core Temperature

时间窗: Until the end of surgery, up to 5 hour

Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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