- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766856
Eustachian Tube Function and Myringoplasty/Tympanoplasty
Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study involves 1 visit to Children's Hospital of Pittsburgh of UPMC for Eustachian tube function testing and 2 visits, at approximately 6 months and at 12 months, after surgery to examine the ears.
Entry (Visit 1; approximately 40-60 minutes) At the entry visit, the child's medical history will be reviewed to ensure he/she is eligible for the study. The parent will be asked questions about their family, including family size, pets, medical history, tobacco smoke exposure, education and occupation, and living conditions. They will also be asked questions about their child, regarding such things as breastfeeding, daycare, tobacco smoke exposure and allergies, and a detailed history of middle-ear disease will be recorded. The child will have an examination of the ears, nose and throat.
Tympanometry will be done, which can help to tell whether there is fluid in the middle ear and whether there is an opening/hole in the eardrum. This is a common office procedure and is done by inserting a small probe (a rubber or plastic tube that measures ear pressure) half way into the ear canal and changing the pressure in the probe. That pressure change is small, can be felt but is rarely associated with any discomfort.
The function of the child's Eustachian tube on the side of the eardrum that is going to be patched will be tested. A small ear plug will be sealed partway into the child's ear canal. This plug is attached to a machine that can change the pressure in the ear and measure the pressure at which the Eustachian tube opens and closes, as well as the ease of airflow through the Eustachian tube and the ability to open the Eustachian tube during swallowing. The tests only require that the child not pull the ear plug from his/her ear and perform certain (age-appropriate) procedures designed to open his/her Eustachian tube such as swallowing with an open and pinched nose, blowing against a closed nose and deep breathing. The total time for testing is about 20 minutes and this period is broken into times of rest and times of tests. If the child has holes in both eardrums that are going to be repaired, testing may take 40 minutes.
After the entry testing: The child's ear surgeon will take a picture of the eardrum at the time of surgery to document the size of the hole. If the child does not require another surgical procedure after the surgery to close the eardrum because of failure of the hole to close or recurrence of ear problems such as infection or fluid in the ear, the child will have study visits for examination of the ears, nose and throat as well as tympanometry at approximately 6 months and 12 months after surgery. If he or she is being seen by the ear surgeon around these times, the study visit and their clinic visit can be done at the same time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- ENT Research Center, Children's Hospital of Pittsburgh of UPMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 3-16 years old
- being scheduled for myringoplasty/tympanoplasty with removal of a patent tube or for repair of existing eardrum perforation remaining after a tube
- less than or equal to 8 weeks prior to surgery
Exclusion Criteria:
- syndromic or with craniofacial malformation (eg, Down syndrome, cleft palate)
- parent anticipates being unable to keep appointments (e.g., moving out of area)
- child unable to tolerate testing
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children undergoing myringoplasty/tympanoplasty
child having repair of eardrum because of hole in eardrum after tube extruded or after tube removal
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Eustachian tube function testing will consist of some or all of the following tests: Inflation/Deflation test, Forced Response test, Compliance test,Valsalva, Toynbee and Sniffing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing of perforation
Time Frame: 12 months
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Evidence of intact eardrum at 12 months after surgery
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12 months
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Recurrence of otitis media
Time Frame: by 12 months
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Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months
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by 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaretha L Casselbrant, MD, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO12040564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Eustachian tube function testing
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