Eustachian Tube Function and Myringoplasty/Tympanoplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Department of Pediatric Otolaryngology
Information provided by (Responsible Party):
Margaretha L. Casselbrant, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01766856
First received: January 10, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Tympanic Membrane Perforation
Other: Eustachian tube function testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Healing of perforation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evidence of intact eardrum at 12 months after surgery

  • Recurrence of otitis media [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
    Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
children undergoing myringoplasty/tympanoplasty
Children undergoing myringoplasty/tympanoplasty (repair of the eardrum) either because of hole in the eardrum after a tube extruded or after removal of the tube from the eardrum
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

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

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children undergoing myringoplasty/tympanoplasty for eardrum perforation after a tube or after a retained tube is removed.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766856

Contacts
Contact: James Seroky, MA 412-692-5463
Contact: Ellen Mandel, MD 412-692-6214 mandele@pitt.edu

Locations
United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Margaretha L Casselbrant, MD, PhD         
Sub-Investigator: Cuneyt Alper, MD         
Sub-Investigator: Charles Bluestone, MD         
Sub-Investigator: David Chi, MD         
Sub-Investigator: Joseph Dohar, MD         
Sub-Investigator: William J Doyle, PhD         
Sub-Investigator: Douglas Swarts, PhD         
Sub-Investigator: Dennis Kitsko, DO         
Sub-Investigator: Raymond Maguire, DO         
Sub-Investigator: Ellen M Mandel, MD         
Sub-Investigator: Deepak Mehta, MD         
Sub-Investigator: Jeffrey Simons, MD         
Sub-Investigator: Robert Yellon, MD         
Sponsors and Collaborators
University of Pittsburgh
Department of Pediatric Otolaryngology
  More Information

No publications provided

Responsible Party: Margaretha L. Casselbrant, Department Chair, Pediatric ENT, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01766856     History of Changes
Other Study ID Numbers: PRO12040564
Study First Received: January 10, 2013
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
perforation
tympanoplasty
myringoplasty
Eustachian tube function
tympanostomy tube

Additional relevant MeSH terms:
Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 31, 2014