跳至主要内容
临床试验/NCT01649596
NCT01649596已完成不适用

Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

Ascension Health2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2012年8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
94
试验地点
2
主要终点
Incidence of Hypothermic Events

研究概览

简要总结

The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.

详细描述

This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.

This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Open label.

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

  • Subjects are adult patients 18 years and older elective surgery of > 1 hour

排除标准

  • Emergency and/or trauma cases
  • Patients with diminished mental capacity unable to fill out or respond to survey questions.

结局指标

主要结局

Incidence of Hypothermic Events

时间窗: 12 hours

The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).

次要结局

  • Patient Satisfaction(12 hours)

研究者

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

Tarik Wasfie, MD

MD, General Surgeon

Ascension Health

研究点 (2)

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