Cola for Oesophageal Food Bolus Impaction (Cola Trial)

Completed

Conditions: food bolus in oesophagus
Oesophageal food bolus impaction
10018008

Registration Number: NL-OMON50563

Lead Sponsor: AMC Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement of oesophageal food bolus obstruction, defined as either complete<br /><br>or partial resolution:<br /><br>Complete resolution:<br /><br>- Complete symptom resolution and<br /><br>- The ability to swallow saliva.<br /><br><br /><br>Partial resolution:<br /><br>- Improvement in symptoms, but not disappearance and<br /><br>- The ability to swallow saliva.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Intervention complications, defined as:<br /><br>- oesophageal perforation or<br /><br>- mucosal laceration or<br /><br>- bleeding or<br /><br>- aspiration or<br /><br>- any other complication requiring treatment, leading to a prolonged ED stay or<br /><br>requiring hospitalization.</p><br>