Clinical trial NCT00393900: Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Official title: Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media With Effusion
Keywords: otitis media
tympanostomy tube
eustachian tube function
gas exchange
tympanostomy tubes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2006-10-31
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment

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.

Eligibility criteria: 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

Primary outcomes:
measure: middle ear status
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Department, Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Department of Otolaryngology, Children's Hospital of Pittsburgh
name: William J Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ellen Mandel, MD
role: STUDY_DIRECTOR
References:
citation: 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.