Clinical trial NCT06191562: Posterior Vs. Anterior Tympanostomy Tube Placement
Official title: Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Otitis Media in Children
Chronic Otitis Media with Effusion
Recurrent Acute Otitis Media
Keywords: Middle ear ventilation
Otitis media
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 386
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomized control trial with no placebo
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 6 months -14 years
2. Bilateral tympanostomy tube placement
3. First tympanostomy tubes placement
4. Indication for tympanostomy tube placement is otitis media

Exclusion Criteria:

1. Undergoing tympanostomy tube placement for indication other than otitis media
2. Receiving tubes other than Armstrong grommet.
3. 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
4. Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
5. Caregivers who cannot speak, read, or write in English proficiently
6. Prior or current otologic surgery other than tympanostomy tube placement
7. On systemic corticosteroids at the time of enrollment
8. Immunodeficiency (acquired or congenital)
9. Current retraction, cholesteatoma, or middle ear mass
10. Atresia
11. Sensorineural hearing loss
12. Known ossicular chain anomaly

Primary outcomes:
measure: Perforation
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
Secondary outcomes:
measure: Parent-reported otorrhea at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Parent-reported otorrhea at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Provider-observed tube occlusion at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
measure: Retained tubes requiring surgical intervention
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Perforation requiring surgical intervention
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Atrophy or retraction at tube site
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Cholesteatoma
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Hearing loss
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Tube indwelling time before extrusion
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
Other outcomes:
measure: Parent-reported otorrhea at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Parent-reported otorrhea at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Parent-reported otorrhea at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Parent-reported otorrhea at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Parent-reported otorrhea at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Parent-reported blockage of tube lumen at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 2-12 weeks
timeFrame: 2-12 weeks following tympanostomy tube placement
measure: Provider-observed otorrhea at 6 months
timeFrame: 6 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Provider-observed otorrhea at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Provider-observed tube occlusion at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Provider-observed tympanostomy tubes in place and patent at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 12 months
timeFrame: 12 months±30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 18 months
timeFrame: 18 months±30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 24 months
timeFrame: 24 months±30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 30 months
timeFrame: 30 months±30 days following tympanostomy tube placement
measure: Ability to see through lumen and assess tube patency at 36 months
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Ear-specific pure tone average
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
measure: Ear-specific speech-response threshold
timeFrame: 36 months±30 days following tympanostomy tube placement
measure: Ear-specific speech-awareness threshold
timeFrame: Within 36 months +/- 30 days following tympanostomy tube placement
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Sewickley
country: United States
facility: UPMC Children's Hospital of Pittsburgh North
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David H Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ALBERTI PW. EPITHELIAL MIGRATION ON THE TYMPANIC MEMBRANE. J Laryngol Otol. 1964 Sep;78:808-30. doi: 10.1017/s0022215100062800. No abstract available.
citation: 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.
citation: Gibb AG, Mackenzie IJ. The extrusion rate of grommets. Otolaryngol Head Neck Surg. 1985 Dec;93(6):695-9. doi: 10.1177/019459988509300601.
citation: 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.
citation: 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.
citation: Stinson WD. Reparative processes in the membrana tympani: some interested manifestations. Arch Otolaryngol. 1936; 24(5): 600-605. doi:10.1001/archotol.1936.00640050613006.