The objective of the study is to assess the efficacy and safety of cola as the initial treatment of complete oesophageal food bolus impactions.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of oesophageal food bolus obstruction, defined as either complete
or partial resolution:
Complete resolution:
- Complete symptom resolution and
- The ability to swallow saliva.
Partial resolution:
- Improvement in symptoms, but not disappearance and
- The ability to swallow saliva.
Secondary outcome
Intervention complications, defined as:
- oesophageal perforation or
- mucosal laceration or
- bleeding or
- aspiration or
- any other complication requiring treatment, leading to a prolonged ED stay or
requiring hospitalization.
Background summary
Oesophageal food bolus impaction presentations are commonly seen in the
emergency department (ED), with an estimated annual incidence rate of 13 per
100,000 persons.1 These patients are often acutely uncomfortable, drooling and
gagging, and at risk for a variety of complications including oesophageal
perforation and aspiration. Males are overly represented. Other risks include:
older age, edentulousness, psychiatric disorders and alcohol intoxication.2,3
Oesophageal pathology is nearly always present,4 with strictures and
eosinophilic esophagitis being the most common abnormalities.1,5 Other causes
include oesophageal webs, malignancies and motility disorders.4
Current guidelines of the American and European Societies for Gastrointestinal
Endoscopy (ASGE and ESGE) recommend emergent endoscopy for complete oesophageal
food bolus obstructions and timely endoscopy for partial food bolus
obstructions.5,3
Disadvantages of emergent endoscopic removal include: discomfort for the
patient whilst waiting for the procedure; discomfort during endoscopy since
adequate sedation is not given per current procedural sedation guidelines to
reduce aspiration risk; risk of aspiration due to a non-fasted state; emergent
health care utilisation with associated ED and gastroenterologist expenses.
Both guidelines do also allow for pre-endoscopy medical management so long as
it does not delay endoscopic removal3,5. A variety of non-endoscopic
medications and interventions are described in the current medical literature,
all with limited or conflicting studies on their use.4,6 Examples include:
butyl scopolamine,7,8 glucagon,9,10 benzodiazepines,11 calcium channel
blockers,12 nitrates,13,14 meat tenderizers (firmly discredited)15 and
effervescent drinks like cola.
Cola as a treatment option has been promulgated for more than 20 years16. Cola
has also been advocated as safe for patients in whom endoscopic removal of a
food bolus is judged to be too risky.17,18 However, evidence on safety and
efficacy is lacking.
We hypothesize that cola can resolve a substantial percentage of complete
oesophageal obstructions.
Study objective
The objective of the study is to assess the efficacy and safety of cola as the
initial treatment of complete oesophageal food bolus impactions.
Study design
multi-centre randomised clinical trial
Intervention
Canned Coca-Cola will be kept in the refrigerator of the Emergency Department.
For every new patient, a new can will be opened.
The patient will be given a bowl or will be placed by the sink because of
likely regurgitation and drooling. Access to suctioning will be ensured. The
patient will be asked by the treating physician or emergency medicine nurse to
swallow a 25ml sip of cola from a standard medication measuring cup. The
patient will always maintain an upright (sitting or standing) position. They
will be asked to wait for 1 minute and if unsuccessful, to continue swallowing
25ml sips at 1-minute intervals. If still unsuccessful after 4 sips, they will
*rest* for 10 minutes in an upright position and then resume 15mins after the
initial sip, repeating the same protocol. If unsuccessful after the second
series of 4 sips, the protocol will be discontinued. In total, the patient will
drink a maximum of 200mls of cola.
Study burden and risks
In the few studies on cola use in oesophageal food bolus impaction published so
far, no adverse events have been described. In studies on carbonated beverages
other than cola, the incidence of adverse events varied between 0-5% and no
serious adverse events were reported.
Cola treatment may induce gagging, coughing, vomiting or regurgitation. It may
give discomfort.
Possible adverse events, known to occur due to food bolus impactions or
endoscopic removal thereof include: oesophageal perforation, mucosal
laceration, bleeding, aspiration.
We choose for Coca Cola to reduce the risk of a pneumonia in case aspiration
has occurred.
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Presence of a complete oesophageal food bolus impaction
- Impaction of soft food (boneless)
- Age >17 years
- Signed written informed consent
- ASA class I, II or III
Exclusion criteria
- A trial of cola or another carbonated beverage before coming to hospital
- Other pre-endoscopic treatment having been given in-hospital or pre-hospital
(such as nifedipine, glucagon, nitrates, butyl scopolamine, benzodiazepines,
calcium channel blockers or other)
- Impaction of non-food items or food known to contain bones or fish bones
- Visible food bolus upon oral inspection
- Significant aspiration risk: reduced consciousness (GCS<14) or significant
aspiration in previous medical history.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL64157.018.18 |
OMON | NL-OMON22494 |