Clinical trial NCT03305848: Esophageal Food Impaction
Official title: Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Food Bolus Obstruction
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients Condition at Discharge
timeFrame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
measure: Medications/Procedures Performed During Visit
timeFrame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Regions Hospital
name: Sam Stellpflug, MD
role: PRINCIPAL_INVESTIGATOR
References: