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OpenTrials
Completed

NCT Number: NCT03305848

Esophageal Food Impaction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitrostat 0.4Mg Sublingual Tablet

Drug

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, and only if systolic blood pressure > 100 mmHg.

Primary outcomes

  1. Patients Condition at Discharge

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

    the proportion of study patients who achieve resolution of food impaction

  2. Medications/Procedures Performed During Visit

    Time frame: 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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction

Acronym: ONEFIT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.