Study of Different Kinds of Ear Tubes

Recurrent Acute Otitis Media Clinical Trial

Official title:

Randomized Controlled Study of Transmyringeal Tubes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00809601
• Other study ID #: 2008/69-31/3
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2008
• Last updated: March 21, 2013
• Start date: May 2008
• Est. completion date: September 2015

Study information

• Verified date: March 2013
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

• Ongoing ear infection

• Previous insertion of ventilation tube

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Otitis
• Otitis Media
• Otitis Media with Effusion
• Otitis Media With Effusion With Hearing Impairment
• Recurrent Acute Otitis Media

Intervention

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

Locations

Country	Name	City	State
Sweden	Danderyds Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Centre for clinical research Vastmanland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete expulsion of the ventilation tube from the tympanic membrane		45 months	No
Secondary	Persistent tympanic membrane perforation		45 months	No
Secondary	Need for tube extraction (pain or infection)		45 months	No
Secondary	Pain leading to health care contact		45 months	No
Secondary	Tube related ear infection		45 months	No
Secondary	Obstruction of the tube		45 months	No
Secondary	Presence of myringosclerosis		45 months	No