Study of Different Kinds of Ear Tubes

Overview

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.

Full Title of Study: “Randomized Controlled Study of Transmyringeal Tubes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2014

Interventions

  • 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)

Arms, Groups and Cohorts

  • Experimental: 1

Clinical Trial Outcome Measures

Primary Measures

  • Time to complete expulsion of the ventilation tube from the tympanic membrane
    • Time Frame: 45 months

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Children aged 1-10 planned for bilateral ventilation tubes Exclusion Criteria:

  • Ongoing ear infection – Previous insertion of ventilation tube

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danderyd Hospital
  • Collaborator
    • Centre for clinical research Vastmanland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Magnus von Unge, Principal investigator – Danderyd Hospital
  • Overall Official(s)
    • Magnus von Unge, MD, PhD, Principal Investigator, ENT-dept Karolinska Hospital
    • Johan Knutsson, MD, Study Director, Centre for clinical research Vastmanland

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