Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Different Kinds of Ear Tubes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Danderyd Hospital.
Recruitment status was:  Active, not recruiting
Centre for clinical research Vastmanland
Information provided by (Responsible Party):
Magnus von Unge, Danderyd Hospital Identifier:
First received: May 2, 2008
Last updated: March 21, 2013
Last verified: March 2013

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.

Condition Intervention
Recurrent Acute Otitis Media
Otitis Media With Effusion With Hearing Impairment
Device: Insertion of a specific type of ventilation tube through the tympanic membrane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Transmyringeal Tubes

Resource links provided by NLM:

Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • Time to complete expulsion of the ventilation tube from the tympanic membrane [ Time Frame: 45 months ]

Secondary Outcome 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 ]

Estimated Enrollment: 400
Study Start Date: May 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)


Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

  • Ongoing ear infection
  • Previous insertion of ventilation tube
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00809601

Danderyds Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Centre for clinical research Vastmanland
Principal Investigator: Magnus von Unge, MD, PhD ENT-dept Karolinska Hospital
Study Director: Johan Knutsson, MD Centre for clinical research Vastmanland
  More Information

Responsible Party: Magnus von Unge, Principal investigator, Danderyd Hospital Identifier: NCT00809601     History of Changes
Other Study ID Numbers: 2008/69-31/3
Study First Received: May 2, 2008
Last Updated: March 21, 2013

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Hearing Loss
Ear Diseases
Otorhinolaryngologic Diseases
Hearing Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 25, 2017