Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Completed

• Conditions: Otitis Media With Effusion

• Registration Number: NCT00393900
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.

Detailed Description

This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-10-31
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 3-6 years old
• History of chronic otitis media with effusion(OME)
• Scheduled or within 6 weeks of tube insertion
• OME at entry or surgery
• Generally good health

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Exclusion Criteria

• Cleft palate or other syndromes predisposing to OM
• History of recurrent acute otitis media only
• History of complications of OM or its treatment
• Unable to cooperate for testing

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
middle ear status	12 months	middle-ear status at 12 months after tympanostomy tube became non-functional

Trial Locations

Locations (1)

ENT Department, Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States