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临床试验/NCT03305848
NCT03305848已完成4 期

Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Patients Condition at Discharge

研究概览

简要总结

This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food impaction. The main hypothesis is to determine the success rate of oral nitroglycerin solution in relieving the food impaction by assessing the resolution of symptoms and the ability of the patient to swallow.

详细描述

A piece of food stuck in the esophagus (the tube connecting the mouth to the stomach) is a relatively common occurrence, estimated at a rate of 13 episodes per 100,000 people per year, mostly men, and usually attributed to swallowed meat. The current standard of care for patients presenting to an Emergency Department with this problem includes a trial of medication, usually glucagon but sometimes a carbonated beverage, an injection of nitroglycerin, or benzodiazepines. The medical interventions mentioned above have not been shown to be significantly effective and have unwanted side effects; glucagon is known to cause nausea and vomiting and benzodiazepines can cause sedation and depressed breathing. If the medication fails to relieve the problem, the patient may require a procedure called endoscopy, where a video scope and retrieval tool are inserted into the esophagus to remove the piece of food. There is significant risk associated with endoscopy, including the risks of anesthesia as well as with the physical procedure itself. Endoscopy also results in a prolonged hospital stay due to the time required for the procedure, as well as from anesthesia recovery. The ideal treatment would be a safe, inexpensive, quickly effective medication without significant side effects that could be administered without sedation or extensive monitoring. Oral nitroglycerin solution might just be that intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over the age of 18 years
  • Presentation consistent with esophageal food impaction
  • Ability to swallow a small volume of liquid.

排除标准

  • Intractable vomiting
  • Hemodynamic instability or SBP <100 mmHg
  • Concern for or evidence of significant airway compromise
  • Concern for or evidence of esophageal perforation,
  • Concern for or evidence of coronary ischemia
  • Presentation > 12 hours since onset.

研究组 & 干预措施

Oral nitroglycerin solution

Other

Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes

干预措施: Nitrostat 0.4Mg Sublingual Tablet (Drug)

结局指标

主要结局

Patients Condition at Discharge

时间窗: Length of Emergency Department stay (Time Frame: up to 12 hours)]

the proportion of study patients who achieve resolution of food impaction

Medications/Procedures Performed During Visit

时间窗: Length of Emergency Department stay (Time Frame: up to 12 hours)]

Total number of other medications or procedures used to relieve the esophageal food impaction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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