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临床试验/NCT04996407
NCT04996407已完成不适用

Comparison Effect of Using Between Survival Thermal Blanket and Draping Fabric as Substitute for Perforated Blanket With Forced Air Warmer Usage as Perioperative Warmer : Study on Inadvertent Perioperative Hypotermia in Geratric Patients

Indonesia University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年3月5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
126
试验地点
1
主要终点
Number of participants with hypothermia in survival thermal blanket group

研究概览

简要总结

This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

详细描述

Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.

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
Single (Participant)

入排标准

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

入选标准

  • •Age > 60 years old
  • •Physical status ASA 1-3
  • •Undergo elective surgery under general anesthesia with or without regional anesthesia

排除标准

  • •Thermoregulation disturbance
  • •Abnormal thyroid function
  • •Fever caused by infectious disease in 7 days prior to surgery
  • •Pre-induction hypothermia with temperature below 36 degree
  • •On routine antipiretic
  • •Unstable hemodynamic preoperative and intraoperative

研究组 & 干预措施

survival thermal blanket

Active Comparator

Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia

干预措施: survival thermal blanket (Device)

survival thermal blanket

Active Comparator

Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia

干预措施: draping fabric (Device)

draping fabric

Active Comparator

Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia

干预措施: survival thermal blanket (Device)

draping fabric

Active Comparator

Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia

干预措施: draping fabric (Device)

结局指标

主要结局

Number of participants with hypothermia in survival thermal blanket group

时间窗: end of surgery

Measure by nasopharyngeal thermometer

Number of participants with hypothermia in survival thermal blanket group

时间窗: Before induction

Measure by nasopharyngeal thermometer

Number of participants with hypothermia in survival thermal blanket group

时间窗: every 15 minute during anesthesia

Measure by nasopharyngeal thermometer

次要结局

  • Number of participants with hypothermia in draping fabric group(end of surgery)
  • Number of participants with hypothermia in draping fabric group(Before induction)
  • Number of participants with hypothermia in draping fabric group(every 15 minute during anesthesia)

研究者

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

Aida Rosita Tantri

Doctor

Indonesia University

研究点 (1)

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