Study of Different Kinds of Ear Tubes
Not Applicable
- Conditions
- Otitis Media With Effusion With Hearing ImpairmentRecurrent Acute Otitis Media
- Interventions
- Device: Insertion of a specific type of ventilation tube through the tympanic membrane
- Registration Number
- NCT00809601
- Lead Sponsor
- Danderyd Hospital
- Brief Summary
There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.
No-one knows if there are differences between the different kinds of tubes regarding complications.
The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.
To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Children aged 1-10 planned for bilateral ventilation tubes
Exclusion Criteria
- Ongoing ear infection
- Previous insertion of ventilation tube
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Insertion of a specific type of ventilation tube through the tympanic membrane -
- Primary Outcome Measures
Name Time Method Time to complete expulsion of the ventilation tube from the tympanic membrane 45 months
- Secondary Outcome Measures
Name Time Method Pain leading to health care contact 45 months Persistent tympanic membrane perforation 45 months Need for tube extraction (pain or infection) 45 months Tube related ear infection 45 months Obstruction of the tube 45 months Presence of myringosclerosis 45 months
Trial Locations
- Locations (1)
Danderyds Hospital
🇸🇪Stockholm, Sweden