Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 3 - 6 |
| Updated: | 10/21/2017 |
| Start Date: | August 2006 |
| End Date: | October 2012 |
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.
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.
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.
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.
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
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