Posterior vs. Anterior Tympanostomy Tube Placement

NCT06191562 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY22120108
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Middle ear ventilation; Otitis media

Outcome Measures

Primary Outcomes (1)

• Perforation

  Percentage of ears with persistent (\>3 month) perforation of the tympanic membrane

  Within 36 months +/- 30 days following tympanostomy tube placement

Secondary Outcomes (14)

• Parent-reported otorrhea at 2-12 weeks

  2-12 weeks following tympanostomy tube placement

• Parent-reported otorrhea at 6 months

  6 months±30 days following tympanostomy tube placement

• Provider-observed tube occlusion at 2-12 weeks

  2-12 weeks following tympanostomy tube placement

• Provider-observed tube occlusion at 6 months

  6 months±30 days following tympanostomy tube placement

• Provider-observed tympanostomy tubes in place and patent at 2-12 weeks

  2-12 weeks following tympanostomy tube placement

Other Outcomes (37)

• Parent-reported otorrhea at 12 months

  12 months±30 days following tympanostomy tube placement

• Parent-reported otorrhea at 18 months

  18 months±30 days following tympanostomy tube placement

• Parent-reported otorrhea at 24 months

  24 months±30 days following tympanostomy tube placement

Study Arms (2)

Posterior Tympanostomy Tube Left

EXPERIMENTAL

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

Device: Tympanostomy tube

Posterior Tympanostomy Tube Right

EXPERIMENTAL

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

Device: Tympanostomy tube

Interventions

Tympanostomy tube 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.

Also known as: Myringotomy with tubes; pressure equalization tubes; ventilation tubes

Posterior Tympanostomy Tube Left; Posterior Tympanostomy Tube Right

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 6 months -14 years
• Bilateral tympanostomy tube placement
• First tympanostomy tubes placement
• Indication for tympanostomy tube placement is otitis media

You may not qualify if:

• 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

Sponsors & Collaborators

• David Chi, MD: lead

Study Sites (2)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

UPMC Children's Hospital of Pittsburgh North

Sewickley, Pennsylvania, 15143, United States

Location

Related Publications (6)

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

  PMID: 14205963 BACKGROUND

• 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.

  PMID: 6380208 BACKGROUND

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

  PMID: 3937089 BACKGROUND

• 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.

  PMID: 25582620 BACKGROUND

• 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.

  PMID: 16436981 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• David H Chi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental, randomized control trial with no placebo

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
• Access Criteria: IPD will be shared with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal. Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.

Locations

US (2)