Esophageal Food Impaction

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.

• 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

• 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

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Patients Condition at Discharge (Primary), Count of participants, Participants: Oral Nitroglycerin Solution 2
• Medications/Procedures Performed During Visit (Primary), Count of participants, Participants: Oral Nitroglycerin Solution 7

Adverse events

Time frame: 7 days

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-07-26)

• Sam Stellpflug, MD, Principal investigator, Regions Hospital