Clinical trial NCT01766856: Eustachian Tube Function and Myringoplasty/Tympanoplasty
Official title: Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tympanic Membrane Perforation
Keywords: perforation
tympanoplasty
myringoplasty
Eustachian tube function
tympanostomy tube
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Department of Pediatric Otolaryngology
First posted: 2013-01-11
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing myringoplasty/tympanoplasty for eardrum perforation after a tube or after a retained tube is removed.

Brief summary: This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. When a person goes up in an airplane and their ears "pop" or when one yawns and their ears "pop", that is the Eustachian tube opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as in the environment and keeping the middle ear free of fluid. It is thought that in children with middle-ear disease, the muscles that open the Eustachian tube do not work very well; this seems to get better in many children as they get older. It is thought that poor Eustachian tube function is the cause of failures when holes in the eardrum are patched and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see whether it can be predicted, based on testing Eustachian tube function before surgery, whether patching the eardrum will be successful and whether fluid will come back in the ear after it is patched.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing of perforation
timeFrame: 12 months
measure: Recurrence of otitis media
timeFrame: by 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Research Center, Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Margaretha L Casselbrant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: