Esophageal Food Impaction

Phase 4

Completed

• Conditions: Esophageal Food Bolus Obstruction
• Interventions: Drug: Nitrostat 0.4Mg Sublingual Tablet

• Registration Number: NCT03305848
• Lead Sponsor: HealthPartners Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-10
• Status Verified: 2018-09
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Disposition First Submitted: 2020-05-05
• Disposition First Submitted QC: 2020-05-05
• Disposition First Posted: 2020-05-08
• Results First Submitted: 2023-01-11
• Results First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral nitroglycerin solution	Nitrostat 0.4Mg Sublingual Tablet	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

Primary Outcome Measures

Name	Time	Method
Patients Condition at Discharge	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	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

Trial Locations

Locations (1)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States