Esophageal Food Impaction (ONEFIT)

HealthPartners Institute

Status and phase: Completed; Phase 4

Conditions: Esophageal Food Bolus Obstruction

Treatments: Drug: Nitrostat 0.4Mg Sublingual Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03305848

A17-134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Oral nitroglycerin solution

Other group

Description:

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

Treatment:

Drug: Nitrostat 0.4Mg Sublingual Tablet