Posterior Vs. Anterior Tympanostomy Tube Placement

NCT ID: NCT06191562

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2028-02-29

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.

Conditions

Otitis Media in Children; Chronic Otitis Media with Effusion; Recurrent Acute Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Posterior Tympanostomy Tube Left

Patients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).

Group Type: EXPERIMENTAL

Tympanostomy tube

Intervention Type: DEVICE

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.

Posterior Tympanostomy Tube Right

Patients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).

Group Type: EXPERIMENTAL

Tympanostomy tube

Intervention Type: DEVICE

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.

Interventions

Tympanostomy tube

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.

Intervention Type: DEVICE

Other Intervention Names

Myringotomy with tubes; pressure equalization tubes; ventilation tubes

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David Chi, MD

OTHER

Sponsor Role: lead

Responsible Party

David Chi, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David H Chi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh North

Sewickley, Pennsylvania, United States

Countries

United States

References

ALBERTI PW. EPITHELIAL MIGRATION ON THE TYMPANIC MEMBRANE. J Laryngol Otol. 1964 Sep;78:808-30. doi: 10.1017/s0022215100062800. No abstract available.

Reference Type: BACKGROUND

PMID: 14205963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6380208 (View on PubMed)

Gibb AG, Mackenzie IJ. The extrusion rate of grommets. Otolaryngol Head Neck Surg. 1985 Dec;93(6):695-9. doi: 10.1177/019459988509300601.

Reference Type: BACKGROUND

PMID: 3937089 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25582620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16436981 (View on PubMed)

Stinson WD. Reparative processes in the membrana tympani: some interested manifestations. Arch Otolaryngol. 1936; 24(5): 600-605. doi:10.1001/archotol.1936.00640050613006.

Reference Type: BACKGROUND

Other Identifiers

STUDY22120108

Identifier Type: -

Identifier Source: org_study_id