Esophageal Food Impaction

Esophageal Food Bolus Obstruction Clinical Trial

— ONEFIT  

Official title:

Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305848
• Other study ID #: A17-134
• Status: Completed
• Phase: Phase 4
• Start date: August 25, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: September 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Food Bolus Obstruction

Intervention

Drug:
• 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, and only if systolic blood pressure > 100 mmHg.

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Condition at Discharge	the proportion of study patients who achieve resolution of food impaction	Length of Emergency Department stay (Time Frame: up to 12 hours)]
Primary	Medications/Procedures Performed During Visit	Total number of other medications or procedures used to relieve the esophageal food impaction	Length of Emergency Department stay (Time Frame: up to 12 hours)]