Eustachian Tube Function and Myringoplasty/Tympanoplasty
|ClinicalTrials.gov Identifier: NCT01766856|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : January 11, 2013
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment|
|Tympanic Membrane Perforation||Other: Eustachian tube function testing|
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 :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2, 2017|
|Actual Study Completion Date :||November 2, 2017|
children undergoing myringoplasty/tympanoplasty
child having repair of eardrum because of hole in eardrum after tube extruded or after tube removal
Other: Eustachian tube function testing
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
- Healing of perforation [ Time Frame: 12 months ]Evidence of intact eardrum at 12 months after surgery
- Recurrence of otitis media [ Time Frame: by 12 months ]Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766856
|United States, Pennsylvania|
|ENT Research Center, Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Margaretha L Casselbrant, MD, PhD||University of Pittsburgh|