跳至主要内容
临床试验/NCT04935632
NCT04935632已完成不适用

Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)

Centre Leon Berard1 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2021年6月21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
388
试验地点
1
主要终点
Incidence of intraoperative hypothermia

研究概览

简要总结

Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • >= 18 years old
  • surgeries performed at the Centre Léon Bérard

排除标准

  • Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
  • Patient who decline to participate in the study
  • Active systemic infection
  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
  • Deprivation of liberty
  • operation performed under local anesthesia only

结局指标

主要结局

Incidence of intraoperative hypothermia

时间窗: Up to 24 hours

From the time of entry into the operating room to the time of exit from the operating room. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

次要结局

  • Intraoperative tympanic temperature(Up to 24 hours)
  • Incidence of hypothermia in the post-anesthesia care unit (PACU)(Up to 24 hours)
  • Tympanic temperature in the post-anaesthesia care unit (PACU)(Up to 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Perioperative Collection of Temperatures and... | 临床试验