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临床试验 NCT07006142 针对Upper Endoscopy，GLP1-R-related Disease目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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妙佑医疗国际Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists 150
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临床试验NCT07006142是一项针对Upper Endoscopy，GLP1-R-related Disease的干预性研究试验，目前试验状态为招募中。试验始于2025年8月1日，计划招募150名患者。该研究由妙佑医疗国际主导，预计于2026年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月3日。
简要概括
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 ...显示更多
官方标题
Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
疾病
Upper EndoscopyGLP1-R-related Disease其他研究标识符
- 23-013192
NCT编号
实际开始日期
2025-08-01
最近更新发布
2026-02-03
预计完成日期
2026-04-30
计划入组人数
150
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
GLP1 receptor agonists
upper endoscopy
upper endoscopy
主要目的
预防
分配方式
不适用
干预模型
单组试验
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预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 | 不适用 |
无干预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 | 不适用 |
实验性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. | Modified Fasting Guidelines Patients will follow a full-liquid diet 48 hours prior to their procedure, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gastric contents | Number of patients who were found to have gastric contents within the stomach during the upper endoscopy. | Baseline |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Diagnosis of aspiration within 72 hours of procedure | Whether or not a patient was diagnosed with aspiration will be determined via chart review for 72 hours after the completion of upper endoscopy. A note documenting aspiration or an ICD code associated with aspiration will indicate that this outcome occurred. | From the time of upper endoscopy until 72 hours post-procedure. |
Aspiration pneumonitis diagnosis postoperatively | The number of patients who have a diagnosis of aspiration pneumonitis, as identified by the presence of ICD codes J69.0 or J69.8, postoperatively. | 72 hours after completion of upper endoscopy |
Postprocedural ICU admission | The number of patients who were admitted to the ICU immediately after upper endoscopy. | Immediately after upper endoscopy |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Patients undergoing elective upper endoscopy with gastroenterology team
- 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
妙佑医疗国际861 个活跃的临床试验可供探索研究责任方
Krishnan Ramanujan, 主要研究者, Principal Investigator, Mayo Clinic
研究中心联系人
联系人: Krishnan Ramanujan, MD, 507-422-4898, [email protected]
1 位于 1 个国家/地区的研究中心
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Krishnan Ramanujan, MD, 联系人, 507-422-4898, [email protected]
招募中