Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.
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
- 否
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
Petr Štourač, MD
Doc.MD.Ph.D
Brno University Hospital
