To evaluate the accuracy of gastric content volume estimation by ultrasonography in fasting patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- To evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy.
研究概览
简要总结
Pulmonary aspiration of gastric contents is one of the most dreaded complications of anesthesia. It predisposes the patients to lethal consequences secondary to lung injury from aspirated particulate matter, acid, and bacteria. Aspiration pneumonitis or Mendelson’s syndrome is a condition that occurs as a result of aspiration of very acidic sterile gastric fluid of volume >25 ml and pH <2.5 . Hence, preoperative estimation of gastric content volume with ultrasound remains a very valuable asset in assessing and reducing the perioperative risk of pulmonary aspiration.
A prospective, randomized, interventional study will be conducted on 315 ASA I-IV adult patients undergoing endoscopic procedures under mild sedation. Gastric content volume will be first assessed preoperatively with Gastric ultrasonography (GUS). Later, gastric contents will be suctioned by the endoscopist under direct vision. Data collected will be statistically correlated and analysed.
Our aim of study and primary outcome will be to evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy. The secondary outcome will be to correlate the residual gastric volume with the duration of fasting for liquids, semisolids and solids.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years.
- •Either Sex.
- •Ability to understand the study procedures and provide informed consent.
- •5.Fasting as per ASA guidelines (2022-2023).
排除标准
- •1.Age less than 18 years.
- •Patients with difficulty in assessment by gastric ultrasonography.
- •Patient with upper gastrointestinal bleed.
- •4.Previous lower esophageal or gastric surgery.
- •Abnormal upper gastrointestinal anatomy e.g., hiatus hernia and gastric tumours etc
- •Gastric outlet obstruction.
- •Patient taking prokinetic drugs.
- •Refusal by patient.
- •Non fasting patients [not following ASA guidelines (2022-2023)].
结局指标
主要结局
To evaluate the accuracy of volume estimated by ultrasonography and its quantitative correlation with gastric contents suctioned via endoscopy.
时间窗: 10 minutes
次要结局
- To correlate the residual gastric volume with the duration of fasting for liquids, semisolids & solids.(6-8 hours)