Peri-operative Hypothermia in Children: Improving Outcomes With Risk Prediction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Duration (minutes) of perioperative hypothermia
研究概览
简要总结
This study aims to determine the incidence of hypothermia in the local paediatric population in the peri-operative period, identify the risk factors involved, and thereafter develop and implement clinical practice guidelines to reduce IPH such that temperature monitoring and heat conservation measures can be implemented in a cost-effective way. The secondary objectives are to determine the adverse outcomes of hypothermia and warming measures
详细描述
Background Hypothermia, defined as core body temperature less than 36 degrees Celsius, occurs frequently during the course of surgery in patients across all ages, especially in the young. It causes significant medical consequences including cardiac events, bleeding, surgical site infection, increased shivering and patient discomfort, as well as longer hospital stays. Although guidelines exist for health care providers in terms of temperature management during surgery, these guidelines are not always followed as the warming measures can be costly, for example, single-use temperature probes and disposable blankets, with potential risks of the equipment overheating causing burns and contamination during surgery
Methodology The investigators aim to include up to 6,000 children presenting for either scheduled or emergency surgeries. Core temperature before, during and after surgery using routine temperature monitoring devices such as tympanic, axillary, oral, rectal and SPOTON (a non-invasive method using a sticker placed on the forehead) will be measured. Other outcomes collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries, shivering, discomfort, length of PACU and length of hospitalization, wound infection rates, . Patients will receive the usual heat-loss prevention and warming measures.
Interim analysis of the first 2000 patients using the SPOTON method of continuous core temperature monitoring will be done to determine incidence and duration of peri-operative hypothermia. This monitoring modality will be compared for agreement with the conventional tympanic and forehead infra-red thermoscan methods. Patient and perioperative risk factors predisposing to hypothermia will be identified to guide in the formulation of clinical practice guidelines tailored to the local population. Guidelines will be implemented, and post-implementation incidence of IPH will be determined A pre- versus post-implementation cost analysis will be carried out.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All paediatric patients ages 16 and younger undergoing elective or emergency surgeries in paediatric major and day surgical operating theaters in KK women's and Children's Hospital.
排除标准
- •Patients undergoing operative procedures under local anaesthesia
- •Patients with impaired temperature control e.g., severe head injury, febrile illness
- •Patients who are admitted to intensive care unit (ICU) post-operatively.
结局指标
主要结局
Duration (minutes) of perioperative hypothermia
时间窗: From induction of anaesthesia to discharge from PACU, approximately 8 hours
Hypothermia is defined as Core temperature\<36 degrees Celsius. Duration of hypothermia is defined as the duration of time in minutes where temperature is less than 36 degrees celsius.
Incidence (%) of perioperative hypothermia
时间窗: From induction of anaesthesia to discharge from PACU, approximately 8 hours
Hypothermia is defined as Core temperature\<36 degrees Celsius. Incidence of hypothermia is the occurence of hypothermia, measured in percentage(%).
次要结局
- Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury(From induction of anaesthesia to discharge from PACU, approximately 8 hours)
- Incidence of short term adverse outcomes of IPH in the paediatric population(From induction of anaesthesia to discharge from PACU, approximately 8 hours)
- Incidence of long term adverse outcomes of IPH in the paediatric population(From PACU discharge time up to 6 months post-surgery)