Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Otitis Media With Effusion

Keywords

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otitis media tympanostomy tube eustachian tube function gas exchange tympanostomy tubes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children with tympanostomy tubes for chronic OME

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ellen M. Mandel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William J Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Children's Hospital of Pittsburgh

Ellen Mandel, MD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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ENT Department, Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Mandel EM, Swarts JD, Casselbrant ML, Tekely KK, Richert BC, Seroky JT, Doyle WJ. Eustachian tube function as a predictor of the recurrence of middle ear effusion in children. Laryngoscope. 2013 Sep;123(9):2285-90. doi: 10.1002/lary.24021. Epub 2013 Apr 10.

Reference Type RESULT

PMID: 23575552 (View on PubMed)

Other Identifiers

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NIH 1P50DC007667

Identifier Type: -

Identifier Source: secondary_id

#0605013