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临床试验/CTRI/2024/11/077330
CTRI/2024/11/077330已完成不适用

Comparision of Ultrasound Guided Fasted Gastric Residual Volume between Diabetic and Non-Diabetic Patients Scheduled for Elective Surgeries- An Analytical Cross Sectional Study

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年12月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
To compare fasted gastric residual volume between diabetic and non- diabetic patients scheduled for elective surgeries by estimating antral cross sectional area by using ultrasound.

研究概览

简要总结

Aspiration of gastric contents during perioperative period is one of the most feared

complications with high fatality rate in anaesthesia.

• Overall incidence of gastric content aspiration ranges between <0.1% and 19% and

[1] ,[2]

aspiration pneumonia accounts for 9% of all anaesthesia related mortality.

• Patients with long-standing diabetes have a higher incidence of autonomic

dysfunction causing gastropathy and delayed gastric emptying which predisposes

[3]

them to increased risk of aspiration, than non-diabetic fasted population.

• American Society of Anesthesiologists (ASA) in 2017 came up with the conclusion

that patients with concomitant diseases like obesity , diabetes mellitus, obstetric

patients, critically ill patients have prolonged stomach emptying time, so it requires

increasing the standard nil per oral (NPO)

• Gastric ultrasound (GUS) is an emerging point of care diagnostic tool to examine

stomach contents, determine the gastric residual volume and pulmonary aspiration

risk at the bedside.

• This is also helpful in guiding the anesthesiologist in airway management in the acute

care setting , when nil per oral(NPO) status is doubtful or unknown or patient has

conditions or comorbidities like diabetes mellitus(DM) that effect gastric emptying.

• Studies have shown an association of gastroparesis with duration of diabetes

mellitus(DM) and other factors such as age and body mass index (BMI). [2]

.

• Therefore we planned this analytical cross sectional study with an aim to compare

gastric volume between diabetic and non-diabetic patients using gastric ultrasound

in fasted state

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

  • INCLUSION CRITERIA FOR DIABETIC PATIENTS:
  • American Society of Anesthesiology (ASA) physical status II, III scheduled for elective surgery.
  • Patients of both sexes aged more than 18 years.
  • Patients with diabetic history of more than 5 years .
  • Body mass index [BMI] less than 35 kg/m2 INCLUSION CRITERIA FOR NON- DIABETIC PATIENTS
  • American Society of Anesthesiology (ASA) physical status I, II, III scheduled for elective surgery
  • Body mass index [BMI] less than 35 kg/m2.

排除标准

  • Patient on medication of upper gastrointestinal symptoms .
  • Gastroesophageal reflux disease .
  • Previous gastrointestinal surgery .
  • Recent abdominal trauma .
  • Chronic kidney disease .
  • Pregnant patients .

结局指标

主要结局

To compare fasted gastric residual volume between diabetic and non- diabetic patients scheduled for elective surgeries by estimating antral cross sectional area by using ultrasound.

时间窗: This will be done preoperatively

次要结局

  • To find association between ultrasound-guided fasted gastric residual volume and duration of diabetes in patients scheduled for elective surgeries.(This will be done preoperatively)
  • To find association between ultrasound-guided fasted gastric residual volume and body mass index (BMI) in patients scheduled for elective surgery.(This will be done preoperatively)

研究者

发起方
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dungala Sampreeti

NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital

研究点 (1)

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