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临床试验/NCT03273894
NCT03273894已完成不适用

Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Influence of the hypothermia on the coagulation status

研究概览

简要总结

Perioperative hypothermia carries high risk of associated complications. In the observational study, the standard perioperative temperature management will be evaluated and the influence of the hypothermia on the coagulation system according to routine coagulation testing in combination with ROTEM will be evaluated.

详细描述

Perioperative hypothermia is one of the complications of surgical interventions in total or regional anaesthesia. It is defined as a drop in body core temperature under 36°C. It occurs as a result of combination of anaesthesia, effecting of central thermoregulation control, environment temperature (i.e. operating theatre) and unsufficient isolation combined with patient's unability to actively warm up. As the body temperature drop in patients under anaesthesia is very frequent, body temperature checks became part of surgical patients care optimalisation. Furthermore, it is associated with complications, such as higher incidency of surgical wound infection, elongated healing process, longer time spent in a hospital, cardiac complications, elongated effect of most of anaesthetics, immunity and blood clotting disorders. Hypothermia elongates the initial phase of coagulation and results in thrombocytes malfunction. Normothermia reduces blood loss.

This prospective observative study has two parts. In the first one, investigators will evaluate the perioperative management of temperature in paediatric patients in Department of children anaesthesia and intensive care, University hospital Brno, Czech republic, where is intended to involve 1,000 patients. In the second phase, the patients who, based on the first phase of the study, would be the most prone to perioperative hypothermia, will be examined for any change of coagulation parameters related to the hypothermia. Investigators intend to involve 100 consecutive patients of the original group. The examined parameters are standard coagulation tests, EXTEM, FIBTEM tests obtained from a rotational thromboelastometry, or other ROTEM test related to the particular pathology. Investigators will use a standardized method of fluid management to affect dilutional coagulopathy.

Standard perioperative patient's monitoring - temperature sensor monitoring of body temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2

Temperature management:

  • the anaesthetist decides if some warming tools are needed and notes the used ones, which involve: warmed infusion, heating blanked, air warming system, infusion pipe heater, increasing of temperature in the operating theatre, covering the patient or another method of temperature management

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • paediatric patients of age 0 - 18 years (+ 364 days) indicated to a surgical intervention with expected duration longer than 30 minutes
  • informed consent of the patient's legal representative to blood sampling in order to run the coagulation tests

排除标准

  • surgical intervention shorter than 20 minutes for the second phase:
  • disagreement of the patient and their legal representative
  • preexisting blood clotting disorder
  • potential damage on the patient caused by non-indicated blood sampling (newborns with low, very low or extremely low birth weight)

结局指标

主要结局

Influence of the hypothermia on the coagulation status

时间窗: Perioperatively

Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia

次要结局

  • Temperature management(Perioperatively)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

Doc.MD.Ph.D

Brno University Hospital

研究点 (1)

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