An Observational Study to Examine Non-inferiority of the Standard ASA Fasting Guidelines Versus 24-hour Clear Liquid Diet for Gastric Volume in Patients Taking GLP-1 Agonists
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.
研究概览
简要总结
This study will enroll patients 18 years and older who are taking a GLP-1/GIP medication and 1) are scheduled for elective surgery and meet ASA fasting guidelines (nothing by mouth for at least 8 hours prior), or 2) scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior. Participants will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The purpose of this study is to determine if people taking GLP-1 receptor agonists and who fast normally are at an equal risk for having retained gastric contents after appropriately fasting for surgery, compared to patients who are on a liquid only diet for 24 hours prior to surgery.
详细描述
Patients will be classified into one of two groups:
- Taking a GLP-1/GLP-GIP medication and undergoing an elective colonoscopy and have been on a clear liquid diet for the past 24-hours.
or 2. Taking a GLP-1/GLP-GIP medication and undergoing am elective surgery and have fasted appropriately according to ASA guidelines.
All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. This will be completed to determine the amount of retained gastric contents, if any, after fasting properly prior to the procedure. An anesthesiologist attending who is properly trained on performing gastric ultrasounds and listed as a study team member will be the one performing the scan.
The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position (RLD), and the above procedure will be repeated. The measurement of gastric antral cross-sectional area while in the RLD position will be recorded and used to calculate the gastric volume.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days
- •ASA Physical Classification Status 1-3
- •Fall into one of the following groups:
- •Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
- •Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior
排除标准
- •Previous gastric or esophageal surgery
- •Abnormal gastric anatomy
- •Pregnancy
- •Unable to provide written, informed consent
- •Non-English speaking
研究组 & 干预措施
ASA fasting guidelines
Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
干预措施: Gastric Ultrasound (Diagnostic Test)
24-hour clear liquid diet
Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior
干预措施: Gastric Ultrasound (Diagnostic Test)
结局指标
主要结局
Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.
时间窗: From enrollment until completion of pre-operative gastric ultrasound (typically within 3 hours of scheduled procedure).
While the patient is in supine position, the gastric volume will be measured via ultrasound and then calculated using a validated formula, GV (mL) = 27.0+(14.6\*CSA)-(1.28\*age).
次要结局
- Perlas antral grade(From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).)
- Incidence of full stomach on gastric ultrasound assessment(From time of enrollment until the start of surgery, up to 24 hours.)
- Incidence of regurgitation under anesthesia(From induction of anesthesia until end of surgery (up to 8 hours).)
- Incidence of change in anesthetic management based on stomach contents(Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).)
- Differences in "high risk GLP-1" vs "low risk GLP-1"(assessed at time of enrollment from the past 30 days until completion of gastric ultrasound)
研究者
Christopher Wolla
Assistant Professor-Faculty
Medical University of South Carolina