Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00393900

Enrollment

Registered

2006-10-31

Start date

2006-08-31

Completion date

2012-10-31

Last updated

2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media With Effusion

Keywords

otitis media, tympanostomy tube, eustachian tube function, gas exchange, tympanostomy tubes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
middle ear status	12 months	middle-ear status at 12 months after tympanostomy tube became non-functional

Countries

United States

Outcome results