Study of Different Kinds of Ear Tubes

Danderyd Hospital

Status: Unknown

Conditions: Otitis Media With Effusion With Hearing Impairment; Recurrent Acute Otitis Media

Treatments: Device: Insertion of a specific type of ventilation tube through the tympanic membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT00809601

2008/69-31/3

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 1-10 planned for bilateral ventilation tubes

Exclusion criteria

• Ongoing ear infection
• Previous insertion of ventilation tube

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 1 patient group

1

Experimental group

Treatment:

Device: Insertion of a specific type of ventilation tube through the tympanic membrane