Study of Different Kinds of Ear Tubes

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Study of Transmyringeal Tubes

Conditions
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Recurrent Acute Otitis Media, Otitis Media With Effusion With Hearing Impairment

Intervention / Treatment
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* Device: Insertion of a specific type of ventilation tube through the tympanic membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 1-10 planned for bilateral ventilation tubes Exclusion Criteria: Ongoing ear infection Previous insertion of ventilation tube

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Insertion of a specific type of ventilation tube through the tympanic membrane<br>* The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear. The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested. The first combination will test: Shepard tube (double flanged, Fluoroplastic) vs Donaldson tube (double flanged, silicone) The second combination will test: Straight tube (single flanged, Fluoroplastic) vs Armstrong (single flanged, silicone) The third combination will test: Armstrong (single flanged, silicone) vs Donaldson tube (double flanged, silicone) The fourth combination will test: Straight tube (single flanged, Fluoroplastic) vs Shepard tube (double flanged, Fluoroplastic)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete expulsion of the ventilation tube from the tympanic membrane |  | 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent tympanic membrane perforation |  | 45 months | 
| Need for tube extraction (pain or infection) |  | 45 months | 
| Pain leading to health care contact |  | 45 months | 
| Tube related ear infection |  | 45 months | 
| Obstruction of the tube |  | 45 months | 
| Presence of myringosclerosis |  | 45 months |