Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Gastric contents
研究概览
简要总结
The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.
详细描述
The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients undergoing elective upper endoscopy with gastroenterology team
排除标准
- •Urgent or emergent procedure
- •Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure
- •Upper GI barium study performed in past 24 hours.
- •Gastroparesis
- •Achalasia
- •Pancreatitis
- •Use of outpatient pro-motility medications
- •Patient refusal
- •Inability for patient to provide own consent
研究组 & 干预措施
Normal fasting guidelines and not taking GLP1-RAs
Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines
Normal fasting guidelines with GLP1-RAs
Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines
Modified fasting guidelines with GLP1-RAs
Patients who are prescribed and taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who follow the modified fasting guidelines. Modified fasting consists of a full-liquid diet 48 hours prior to the procedures, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure.
干预措施: Modified Fasting Guidelines (Other)
结局指标
主要结局
Gastric contents
时间窗: Baseline
Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.
次要结局
- Diagnosis of aspiration within 72 hours of procedure(From the time of upper endoscopy until 72 hours post-procedure.)
- Aspiration pneumonitis diagnosis postoperatively(72 hours after completion of upper endoscopy)
- Postprocedural ICU admission(Immediately after upper endoscopy)
研究者
Krishnan Ramanujan
Principal Investigator
Mayo Clinic