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Study of Different Kinds of Ear Tubes

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Recurrent Acute Otitis Media

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

Ongoing ear infection
Previous insertion of ventilation tube

Sites / Locations

Danderyds Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Time to complete expulsion of the ventilation tube from the tympanic membrane

Secondary Outcome Measures

Persistent tympanic membrane perforation

Need for tube extraction (pain or infection)

Pain leading to health care contact

Tube related ear infection

Obstruction of the tube

Presence of myringosclerosis

Full Information

NCT ID

NCT00809601

First Posted

May 2, 2008

Last Updated

March 21, 2013

Sponsor

Danderyd Hospital

Collaborators

Centre for clinical research Vastmanland

1. Study Identification

Unique Protocol Identification Number

NCT00809601

Brief Title

Study of Different Kinds of Ear Tubes

Official Title

Randomized Controlled Study of Transmyringeal Tubes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Danderyd Hospital

Collaborators

Centre for clinical research Vastmanland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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)

Primary Outcome Measure Information:

Title

Time to complete expulsion of the ventilation tube from the tympanic membrane

Time Frame

45 months

Secondary Outcome Measure Information:

Title

Persistent tympanic membrane perforation

Time Frame

45 months

Title

Need for tube extraction (pain or infection)

Time Frame

45 months

Title

Pain leading to health care contact

Time Frame

45 months

Title

Tube related ear infection

Time Frame

45 months

Title

Obstruction of the tube

Time Frame

45 months

Title

Presence of myringosclerosis

Time Frame

45 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magnus von Unge, MD, PhD

Organizational Affiliation

ENT-dept Karolinska Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Johan Knutsson, MD

Organizational Affiliation

Centre for clinical research Vastmanland

Official's Role

Study Director

Facility Information:

Facility Name

Danderyds Hospital

City

Stockholm

ZIP/Postal Code

18288

Country

Sweden

12. IPD Sharing Statement

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Study of Different Kinds of Ear Tubes

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