- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06191562
Posterior vs. Anterior Tympanostomy Tube Placement
Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location.
For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems.
Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Study Overview
Status
Intervention / Treatment
Detailed Description
The tympanic membrane can be divided into quadrants: posterior superior, anterior superior, posterior inferior, and anterior inferior. Traditional training dictates that tympanostomy tubes should be placed in the anterior-inferior quadrant, with the thought that this would lead to longer indwelling time in the tympanic membrane, avoidance of damage to the ossicular chain, and prevention of hearing loss due to residual perforation over the round window following tympanostomy tube extrusion. However, more recent work has challenged these assumptions. Notably, there is a 2-16% risk of chronic perforation following tympanostomy tube extrusion, with a proposed annual incidence of more than 40,000 post-tympanostomy tube perforations in the United States each year. While perforations in the posterior tympanic membrane can often be repaired using transcanal approaches, anterior perforations are more likely to require more invasive postauricular or endoaural approaches or canalplasty. To our knowledge, there are no studies reporting outcomes following tympanostomy tube placement in the posterior-inferior quadrant. If this study demonstrates no difference in hearing, tube indwelling time, and sequelae following posterior-inferior placement compared with anterior-inferior, it would allow otolaryngologists greater flexibility to consider patient characteristics such as factors placing them at increased risk for perforation or anatomy of the auditory canal when selecting the section of tympanic membrane in which to place tubes.
Upon completion of screening, patients will be randomized using a random number generator in order to have an equal distribution of left and right ears with tympanostomy tubes placed in the anterior and posterior quadrants. Consented patients will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery. Follow-up will include standard-of-care post-operative visits and may be completed at 2-12 weeks and 5-7 months. Clinicians will examine the child's ears and determine whether otorrhea and occlusion are present. During the visit, audiologists may conduct standard of care ear-specific pure tone average, air-bone gap, and sound field audiometry. At these follow-up visits, otolaryngology providers will complete a form describing the status of the tympanic membrane. This will add <1 minute to the visit. Caregivers will also complete a form asking about the status of their child's tympanostomy tubes and any ear problems their child has experienced since surgery. This will take <5 minutes to complete. Results of audiology testing will be collected from the electronic medical record. Additional follow-up will include administration of the caregiver questions via phone, mail, or REDCap email at 12, 18, 24, 30, and 36 months. If the child has other follow-up clinic visits prior to 37 months post-surgery, the provider form will be completed again during these visits. Further research activities will include viewing medical charts of the included subjects.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amber D Shaffer, PhD
- Phone Number: 412-692-6874
- Email: shafferad@upmc.edu
Study Contact Backup
- Name: Marina V Rushchak, BA
- Phone Number: 412-692-9879
- Email: rushchakmv4@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- UPMC Children's Hospital of Pittsburgh
-
Contact:
- Amber D Shaffer, PhD
- Phone Number: 412-692-6874
- Email: shafferad@upmc.edu
-
Contact:
- Marina V Rushchak, BA
- Phone Number: 412-692-9879
- Email: rushchakmv4@upmc.edu
-
Sewickley, Pennsylvania, United States, 15143
- Recruiting
- UPMC Children's Hospital of Pittsburgh North
-
Contact:
- Amber D Shaffer, PhD
- Phone Number: 412-692-6874
- Email: shafferad@upmc.edu
-
Contact:
- Marina V Rushchak, BA
- Phone Number: 412-692-9879
- Email: rushchakmv4@upmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 6 months -14 years
- Bilateral tympanostomy tube placement
- First tympanostomy tubes placement
- Indication for tympanostomy tube placement is otitis media
Exclusion Criteria:
- Undergoing tympanostomy tube placement for indication other than otitis media
- Receiving tubes other than Armstrong grommet.
- Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia
- Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
- Caregivers who cannot speak, read, or write in English proficiently
- Prior or current otologic surgery other than tympanostomy tube placement
- On systemic corticosteroids at the time of enrollment
- Immunodeficiency (acquired or congenital)
- Current retraction, cholesteatoma, or middle ear mass
- Atresia
- Sensorineural hearing loss
- Known ossicular chain anomaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Posterior Tympanostomy Tube Left
Patients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).
|
Participants will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery.
Other Names:
|
Experimental: Posterior Tympanostomy Tube Right
Patients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).
|
Participants will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perforation
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears with persistent (>3 month) perforation of the tympanic membrane
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent-reported otorrhea at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
2-12 weeks following tympanostomy tube placement
|
Parent-reported otorrhea at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
6 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
2-12 weeks following tympanostomy tube placement
|
Provider-observed tube occlusion at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
6 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
2-12 weeks following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
6 months±30 days following tympanostomy tube placement
|
Retained tubes requiring surgical intervention
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears requiring surgical tympanostomy tube removal
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Perforation requiring surgical intervention
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears with surgical repair of perforation
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Atrophy or retraction at tube site
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears with atrophy or retraction at tube site
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Cholesteatoma
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears with cholesteatoma
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Hearing loss
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Percentage of ears with pure tone average >20 dB or absent otoacoustic emissions
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Tube indwelling time before extrusion
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Months from tympanostomy tube placement to extrusion estimated from parent-report and provider observations
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
2-12 weeks following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
6 months±30 days following tympanostomy tube placement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent-reported otorrhea at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
12 months±30 days following tympanostomy tube placement
|
Parent-reported otorrhea at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
18 months±30 days following tympanostomy tube placement
|
Parent-reported otorrhea at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
24 months±30 days following tympanostomy tube placement
|
Parent-reported otorrhea at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
30 months±30 days following tympanostomy tube placement
|
Parent-reported otorrhea at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears with ear drainage most days (67-100%), many days (33-67%), some days (1-33%) or no days (0)
|
36 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
2-12 weeks following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
6 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
12 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
18 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
24 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
30 months±30 days following tympanostomy tube placement
|
Parent-reported blockage of tube lumen at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears clogged/blocked
|
36 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 2-12 weeks
Time Frame: 2-12 weeks following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
2-12 weeks following tympanostomy tube placement
|
Provider-observed otorrhea at 6 months
Time Frame: 6 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
6 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
12 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
18 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
24 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
30 months±30 days following tympanostomy tube placement
|
Provider-observed otorrhea at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears with otorrhea observed by provider
|
36 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
12 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
18 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
24 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
30 months±30 days following tympanostomy tube placement
|
Provider-observed tube occlusion at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears with tubes occluded
|
36 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
12 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
18 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
24 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
30 months±30 days following tympanostomy tube placement
|
Provider-observed tympanostomy tubes in place and patent at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears with tympanostomy tubes in place and patent
|
36 months±30 days following tympanostomy tube placement
|
Ear-specific pure tone average
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Highest (worst) pure tone average of 500 Hz, 1000 Hz, 2000 Hz, and 3000 Hz in decibels
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Ear-specific speech-response threshold
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Highest (worst) speech-response threshold in decibels
|
36 months±30 days following tympanostomy tube placement
|
Ear-specific speech-awareness threshold
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
|
Highest (worst) speech-awareness threshold in decibels
|
Within 36 months +/- 30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 12 months
Time Frame: 12 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
12 months±30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 18 months
Time Frame: 18 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
18 months±30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 24 months
Time Frame: 24 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
24 months±30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 30 months
Time Frame: 30 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
30 months±30 days following tympanostomy tube placement
|
Ability to see through lumen and assess tube patency at 36 months
Time Frame: 36 months±30 days following tympanostomy tube placement
|
Percentage of ears in which the otolaryngology provider is able to see through lumen and assess tube patency
|
36 months±30 days following tympanostomy tube placement
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David H Chi, MD, University of Pittsburgh
Publications and helpful links
General Publications
- ALBERTI PW. EPITHELIAL MIGRATION ON THE TYMPANIC MEMBRANE. J Laryngol Otol. 1964 Sep;78:808-30. doi: 10.1017/s0022215100062800. No abstract available.
- O'Donoghue GM. The kinetics of epithelial cells in relation to ventilating tubes. Acta Otolaryngol. 1984 Jul-Aug;98(1-2):105-9. doi: 10.3109/00016488409107541.
- Gibb AG, Mackenzie IJ. The extrusion rate of grommets. Otolaryngol Head Neck Surg. 1985 Dec;93(6):695-9. doi: 10.1177/019459988509300601.
- Kivekas I, Poe D. Is there an optimal location for tympanostomy tube placement? Laryngoscope. 2015 Jul;125(7):1513-4. doi: 10.1002/lary.25127. Epub 2015 Jan 13. No abstract available.
- Mehta RP, Rosowski JJ, Voss SE, O'Neil E, Merchant SN. Determinants of hearing loss in perforations of the tympanic membrane. Otol Neurotol. 2006 Feb;27(2):136-43. doi: 10.1097/01.mao.0000176177.17636.53.
- Stinson WD. Reparative processes in the membrana tympani: some interested manifestations. Arch Otolaryngol. 1936; 24(5): 600-605. doi:10.1001/archotol.1936.00640050613006.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22120108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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