Study of Different Kinds of Ear Tubes

NCT00809601 | Unknown

• 1 other identifier: 2008/69-31/3
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  45 months

Secondary Outcomes (6)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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)

1

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-10 planned for bilateral ventilation tubes

You may not qualify if:

• Ongoing ear infection
• Previous insertion of ventilation tube

Sponsors & Collaborators

• Danderyd Hospital: lead
• Centre for clinical research Vastmanland: collaborator

Study Sites (1)

Danderyds Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Magnus von Unge, MD, PhD

  ENT-dept Karolinska Hospital

  PRINCIPAL INVESTIGATOR

• Johan Knutsson, MD

  Centre for clinical research Vastmanland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: December 17, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

SE (1)