跳至主要内容
临床试验/NCT03824262
NCT03824262已完成不适用

The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

Hacettepe University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年2月4日最近更新:
适应症
干预措施

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
Body temperature-esophageal probe

研究概览

简要总结

The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

详细描述

The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Major abdominal surgery in litotomy position
  • •Anticipated operation time over 1 hour

排除标准

  • •Hypothermia
  • •Hyperthermia
  • •Malignant Hyperthermia
  • •Tyroid dysfunction

研究组 & 干预措施

Group I

Experimental

HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device

干预措施: HICO-VARIOTHERM 550 (Device)

Group I

Experimental

HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device

干预措施: Mistral-Air Plus forced air warming device (Device)

Group II

Active Comparator

Mistral-Air Plus forced-air warming device

干预措施: Mistral-Air Plus forced air warming device (Device)

结局指标

主要结局

Body temperature-esophageal probe

时间窗: Perioperative period-every 15 minutes

Esophageal probe used to measure core body temperature

次要结局

  • Body temperature-skin thermometer(Perioperative period-every 15 minutes)
  • Body temperature-tympanic thermometer(Perioperative period-every 15 minutes)
  • Duration of operation(Perioperative period)
  • Time to extubation(The end of the operation)
  • Blood loss(Perioperative period)
  • Shivering after the operation(Postoperative 1st hour every 10 minutes)

研究者

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

Filiz Uzumcugil

Principal Investigator, MD, Asist. Prof.

Hacettepe University

研究点 (1)

Loading locations...

相似试验