Esophageal Food Bolus Obstruction
Conditions
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.
Interventions
DRUGNitrostat 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.
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
20 patients were enrolled who met inclusion for the study.
Participants by arm
| Arm | Count |
|---|---|
| Oral Nitroglycerin Solution 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
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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Symptom resolution after consent, but before study drug administration | 1 |
Baseline characteristics
| Characteristic | Oral Nitroglycerin Solution | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Age, Continuous | 47 years STANDARD_DEVIATION 19.08230098 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 3 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Medications/Procedures Performed During Visit
Total number of other medications or procedures used to relieve the esophageal food impaction
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Nitroglycerin Solution | Medications/Procedures Performed During Visit | Received additional medication | 7 Participants |
| Oral Nitroglycerin Solution | Medications/Procedures Performed During Visit | Underwent endoscopy | 15 Participants |
Primary
Patients Condition at Discharge
the proportion of study patients who achieve resolution of food impaction
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
Population: 17 of 20 enrolled subjects received the intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Nitroglycerin Solution | Patients Condition at Discharge | Resolution with study treatment | 2 Participants |
| Oral Nitroglycerin Solution | Patients Condition at Discharge | Failure of resolution with study treatment | 15 Participants |