Comparison of Incidence of High Risk Stomach in Minimally Fasted with Conventionally Fasted Paediatric Patients Posted for Elective Surgery: A Prospective, Randomized, Single Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Presence or absence of high risk stomach, defined as gastric content more than 1.25ml/kg measured using gastric ultrasound in right lateral decubitus position
研究概览
简要总结
Preoperative fasting reduces the risk of aspiration during anaesthesia, but prolonged fasting in children can lead to discomfort, anxiety, and doesn’t always guarantee an empty stomach. Gastric ultrasound is a reliable, non-invasive method for assessing gastric volume, with >1.25 ml/kg considered high risk for aspiration.
This study compares gastric volumes in two pediatric groups ages 2-12 years posted for elective surgery:
- Group C (Conventional Fasting): Standard fasting—8 hrs for solids, 6 hrs for milk/formula, 2 hrs for clear fluids.
- Group M (Minimal NPO): Same instructions for solid/milk fasting, but allowed sips of water (up to 3 ml/kg/hr, max 30 ml/hr) until transfer to OR.
All patients receive IV fluids according to Holliday-Segar formula. Gastric volume is measured using ultrasound in the pre-op area by a blinded investigator, with calculations based on CSA and Spencer’s formula - Volume = -7.8 + (3.5 × RLD CSA) + (0.127 × age in months). Volume of 1.25ml/kg is taken as threshold for high risk stomach. Anxiety is assessed using mYAS; Serum cortisol is measured post-induction. Additionally, adverse events if any, during induction are noted. Method of induction and the choice of airway device will be as per the plan of the anaesthesiologist managing the patient.
If gastric volume exceeds the high-risk threshold and the last intake is too recent, surgery is postponed and reassessment is done. If risk persists despite adequate fasting, a modified rapid sequence induction (RSI) is performed, with intubation and gastric suction.
All randomized patients are included in the final analysis, regardless of gastric volume at first scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and II Posted for elective surgery.
排除标准
- •Past H/O abdominal surgery H/O gastrointestinal disorders, GERD, achalasia cardia Anticipated difficult airway Prior H/O pulmonary aspiration Presence of delayed development or neurological impairment Last case of the list.
结局指标
主要结局
Presence or absence of high risk stomach, defined as gastric content more than 1.25ml/kg measured using gastric ultrasound in right lateral decubitus position
时间窗: Immediately after being shifted to preoperative area from the ward. Only one reading will be taken
次要结局
- Volume of gastric content measured using gastric ultrasound in right lateral decubitus position(On being shifted to preoperative area from the ward. If the first reading shows high risk stomach, second reading will be taken after a period 2 hours is passed after the previous sip of water)
- Anxiety level using mYAS tool(On being shifted to preoperative area from the ward, prior to measuring gastric volume. Only a single reading will be taken)
- Exact duration of NPO, for solids & clear fluids(At the time of induction, just before starting pre oxygenation.)
- Serum cortisol(Post induction, prior to surgical incision. Only one single sample will be drawn)
- Any adverse events like vomiting, aspiration, desaturation, bronchospasm, laryngospasm(During the period of induction till starting of surgery)
研究者
Rakshith M Adiga
All India Institute of Medical Sciences, Rishikesh