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临床试验/CTRI/2024/01/061834
CTRI/2024/01/061834尚未招募不适用

Assessment of gastric volume and gastric content in patient undergoing elective cardiac surgery using ultrasonography.

KEM hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
KEM hospital
入组人数
50
试验地点
1
主要终点
Evaluation of gastric antrum cross section area ,gastric volume and content using transthoracic ECHO

研究概览

简要总结

Pulmonary aspiration of the gastric contents is a serious perioperativecomplication.  The overall incidence in a mixed surgicalpopulation ranges between <0.1% and 19% depending on patient and surgicalfactors and it has not changed in the last few decades. Aspiration pneumonia is associated with significantmorbidity, including prolonged mechanical ventilation, and carries a risk of mortality asgreat as 5%. Pulmonary aspiration is involved in up to 9% of allanaesthesia-related deaths. One of the main risk factors for aspiration is the presence of gastriccontent. The critical volume threshold of gastric fluid that by itselfincreases aspiration risk is controversial, but healthy, fasted patientsfrequently have residual gastric volumes (GVs) of up to 1.5 ml kg−1 without significant aspiration risk. Sedation and general anaesthesia depress or impedethe physiological mechanisms that protect against aspiration (the tone of thelower oesophageal sphincter and upper airway reflexes). Since restriction of fluid and food intake beforegeneral anaesthesia is vital for patient safety, anaesthesiology societies havedeveloped guidelines for preoperative fasting.. In preoperative fasting guidelines, atleast 2 hours for clear liquids is recommended, 6 hours of fasting for liquidscontaining solid particles and toasted sandwich type solid foods, and 8 hoursof fasting for high calorie and fatty foods. Patients with BMI over 30 and type 2 diabetes may benefitfrom point of care ultrasonography to guide perioperative airway management bystratifying gastric residual volume**.** The evaluation of gastric content byultrasound is a good method to qualitatively and quantitatively assess thegastric volume and thus determine the risk of perioperative pulmonaryaspiration.As cardiac surgeries are longduration surgeries so case posted in afternoon shift  have a prolong fasting period . As per presentCVTS protocol all the patients are kept fasted from midnight so to avoid thisprolong fasting we can do sonography of stomach preoperatively to decidewhether it is needed to keep patient fasting from midnight or we can keep themfasted from morning when posted for afternoon schedule.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient age >18years and <60 years 2.Weight >40 3.BMI <35 kg/m2 4.ASA classification (I, II, III), and elective surgery.

排除标准

  • 1.Age < 18 year >60 years 2.Abnormal anatomy of the upper gastrointestinal system (previous esophagus or gastric surgery, including hiatus hernia) 3.Diabetes mellitus, subocclusive syndrome, or infiltrative diseases such as scleroderma or amyloidosis, GERD, medullar lesion above T10 level, or pregnancy.

结局指标

主要结局

Evaluation of gastric antrum cross section area ,gastric volume and content using transthoracic ECHO

时间窗: Baseline only one reading in the preoperative holding area just prior to administring anaesthesia

次要结局

未报告次要终点

研究者

发起方
KEM hospital
申办方类型
Government medical college

研究点 (1)

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