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| Name | Class |
|---|---|
| Centre for clinical research Vastmanland | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of a specific type of ventilation tube through the tympanic membrane | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete expulsion of the ventilation tube from the tympanic membrane | 45 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus von Unge, MD, PhD | ENT-dept Karolinska Hospital | Principal Investigator |
| Johan Knutsson, MD | Centre for clinical research Vastmanland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyds Hospital | Stockholm | Stockholm County | 18288 | Sweden |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| 45 months |
| Tube related ear infection | 45 months |
| Obstruction of the tube | 45 months |
| Presence of myringosclerosis | 45 months |