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An Epidemiology Survey on the Incidence of Perioperative Hypothermia

2014年7月2日 更新者:Jie YI

An Epidemiology Survey on the Incidence of Perioperative Hypothermia of Patients Undergo Elective Operation With General Anaesthesia in Beijing Area

  • The purpose of this study is to understand and grasp the incidence rate of hypothermia during perioperative period of elective operations under general anaesthesia in Beijing.
  • The purpose of this study is to carry out a subgroup analysis on the survey data and explore the high-risk factors for the incidence of hypothermia.

研究概览

地位

完全的

条件

详细说明

This survey was anticipated to enroll 800 patients who underwent elective operations with general anaesthesia from 24 hospitals in Peking. After obtaining approval from the Ethical Committee related to research involving human subjects,the investigators will enroll the patients according to the inclusion and exclusion criterion. The tympanic temperature(measured by Braun PRO4000 Thermometer) will be monitored at the following time points respectively: arrived at waiting area, enter the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, operation ended,arrived at PACU. Other information will also be collected, the investigators will record the type and dosage of anesthesia drug,duration of surgery and anesthesia, the patient warming method or if it is used.operation room temperature,the amount of the infusion of intravenous fluids and blood,etc. during the whole operation procedure. The other information will be followed up and recorded after the operation(within 30 days postoperation) which incudes ICU stays, hospital stays, incision infection, new cardiology events.etc.

The contract research organization will be delegated to do the site monitor once a week for each hospital participate the survey during the recruitment and perform the source data validation at the same time to review the related medical records,source data and the case report forms, etc.to ensure the data accuracy and completeness

Data management will be conduct through the whole survey procedure. EPIDATA3.1 software was used for compile the inputting procedure for data inputting and management. In order to guarantee the correctness of the data, two data managing staffs should input and verify the data independently.

SAS9.2 statistical analysis software was used for the calculation of all the statistical analyses. The number of cases, mean, standard deviation, median value, maximal value and minimal value should be calculated for the descriptions of the qualitative parameters. Number of cases and percentages are used for the descriptions on the classification parameters.Two side test is used for all the statistical tests, P<0.05 indicates that the difference is statistically significant (unless indicated otherwise), and 95% confidence is used as the confidence interval.

研究类型

观察性的

注册 (实际的)

869

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国、100000
        • Peking Union Medical College Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients who undergo elective surgery with general anaesthesia

描述

Inclusion Criteria:

  • Male or female, no limitation on age
  • Subject who will undergo elective surgery with general anaesthesia
  • The duration of surgery is expected to be over 40 minutes
  • The subject agreed to participate in the study and signed the informed

Exclusion Criteria:

  • Central high fever caused by enter nerves system disease or condition, including that induced by cerebrovascular disease, cerebral trauma, cerebral surgeries, epilepsy and acute hydrocephalus
  • Thermoregulation abnormalities including malignant hyperthermia (MHS) and neuroleptic malignant syndrome, hypothyroidism or hyperthyroidism diagnosed by substantial evidence
  • Infectious fever
  • Patients whose core temperature is higher than 38.5°C within 7 days before surgery
  • Diseases or that may lead to inaccuracy in measurement, such as ear infection
  • Surgeries with active cooling process during operation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Investigation
This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Incidence of Perioperative Hypothermia
大体时间:Perioperative period started from anesthesia induction to surgery ended
Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.
Perioperative period started from anesthesia induction to surgery ended

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Yugung Huang, doctoral、Peking Union Medical College Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2013年7月29日

首先提交符合 QC 标准的

2013年7月30日

首次发布 (估计)

2013年7月31日

研究记录更新

最后更新发布 (估计)

2014年7月16日

上次提交的符合 QC 标准的更新

2014年7月2日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MDI0077

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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