A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia
研究概览
简要总结
The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery.
This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.
It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.
详细描述
This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
The research question is should investigator change fasting protocol for paediatric patients prior to operation.
The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.
This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded against those who are doing ultrasound assessment of gastric residual volume prior to anaesthesia
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-16 years old
- •elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics
排除标准
- •Gastro-oesophageal reflux (GORD)
- •renal failure
- •severe cerebral palsy
- •some enteropathies
- •oesophageal strictures
- •achalasia
- •diabetes mellitus with gastroparesis
- •surgical contra-indications
- •Emergency cases
- •patients that were already intubated
结局指标
主要结局
Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia
时间窗: Prior to induction of general anaesthesia
We use ultrasound to evaluate gastric volume We scanning distal parts of the stomach-antrum in a semi-sitting or RLD position. A linear high-frequency (e.g. 5-12 MHz) transducer can be used in leaner or paediatric patients or to obtain detailed images of the gastric wall(4-6mm). Antral cross sectional area(CSA) can be measured by using two perpendicular diameters and the formula of the area of an ellipse: CSA=(AP×CC×π)/4 (AP=antero-posterior diameter and CC=craniocaudal diameter) GV (ml)=27.0+14.6×right-latCSA-1.28×age(Perlas and colleagues formula) Total gastric residual volume is then divide by body weight to get ml/kg, the lower the value the better the outcome. Referance standard is gastric residual volume acquired through nasogastric suction using nasogastric tube. Result of \>1.5ml/kg show that patient posed risk of aspiration, result of \>1ml/kg is significantly increase in this study
次要结局
- Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia(Prior to induction of general anaesthesia and 1 hour post anaesthesia)
- Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia(2 hours to 24 hours post anaesthesia)
研究者
Ma Tai Jiun
Principal investigator
University of Malaya