Tympanostomy Tube Placement for Ear Infections

Not currently recruiting at 1 trial location

Overseen By Marina V Rushchak, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: David Chi, MD

Must not be taking: Systemic corticosteroids

Disqualifiers: Genetic disorders, Craniofacial abnormalities, Immunodeficiency, Sensorineural hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal placement of ear tubes in children with frequent ear infections (otitis media). Typically, tympanostomy tubes are placed in the front-bottom part of the eardrum, but this study tests a new location at the back-bottom. The aim is to determine if this placement reduces common issues like ear drainage or blockages. Children aged 6 months to 14 years receiving their first set of ear tubes for ear infections are suitable candidates for this trial. The study will monitor the tubes' effectiveness over time and any related ear symptoms. As an unphased trial, this research offers a unique opportunity to contribute to innovative advancements in ear tube placement for children.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic corticosteroids at the time of enrollment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic corticosteroids, you cannot participate in the trial.

What prior data suggests that this tympanostomy tube placement technique is safe?

Research has shown that placing ear tubes is generally safe for children. These tubes help with ear infections by allowing air into the middle ear and preventing fluid buildup. Most children tolerate them well.

A common issue is the tube falling out on its own, which is expected and usually not problematic. In about 2% of cases, the hole left by the tube might not close on its own and could require another surgery, though this is rare. Serious complications are uncommon, and this procedure is a standard treatment for persistent ear issues in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tympanostomy tube placement in the posterior-inferior quadrant of the ear as it offers a novel approach for treating ear infections. Unlike standard tube placement, which typically targets other parts of the eardrum, positioning the tube in this new location might improve drainage and reduce complications. This innovative method could lead to fewer repeat procedures and better overall outcomes for patients with recurring ear infections.

What evidence suggests that tympanostomy tube placement in different ear drum quadrants could be effective for ear infections?

Research has shown that ear tubes, like those used in this trial, can improve hearing in children with ear infections, particularly in the first few months after insertion. These tubes allow air into the middle ear, preventing further infections and balancing pressure. For many children, this results in fewer ear infections and better hearing shortly after tube placement. However, after about a year, the advantages of having tubes compared to not having them seem to diminish. Some studies suggest that while tubes can be beneficial, they might also lead to issues such as long-term hearing problems or changes to the eardrum. This trial will specifically evaluate the placement of tympanostomy tubes in the posterior-inferior quadrant of the ear. ^{1 4 5 6 7}

Who Is on the Research Team?

David H Chi, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children with chronic ear infections. They will receive tympanostomy tubes, commonly known as ear tubes, to help drain fluid and improve hearing. The study requires that one tube be placed in the usual front-lower part of the eardrum and another in the back-lower part.

Inclusion Criteria

I am between 6 months and 14 years old.

I am getting my first ear tubes.

I need ear tubes because of middle ear infections.

Exclusion Criteria

Caregivers who cannot speak, read, or write in English proficiently

I am currently taking corticosteroids.

I have a weakened immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants receive tympanostomy tubes in both ears, with random assignment to anterior-inferior or posterior-inferior quadrants

1 day

1 visit (in-person)

Initial Follow-up

Standard-of-care post-operative visits to assess ear condition, including otorrhea and occlusion, and conduct audiology tests

2-12 weeks

Multiple visits (in-person)

Extended Follow-up

Ongoing monitoring of tympanostomy tube status and ear health through caregiver questionnaires and provider assessments

36 months

Visits at 6, 12, 18, 24, 30, and 36 months (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Tympanostomy Tube Placement

Trial Overview

The study aims to see if placing an ear tube in a different part of the eardrum affects how often complications occur after surgery. Researchers will compare outcomes like healing time, drainage issues, blockages, and whether additional doctor visits are needed.

How Is the Trial Designed?

Group I: Posterior Tympanostomy Tube Right Experimental Treatment 1 Intervention

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

Group II: Posterior Tympanostomy Tube Left Experimental Treatment 1 Intervention

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

Tympanostomy Tube Placement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tympanostomy Tubes for:

• Chronic middle ear infections
• Middle ear effusion
• Barotrauma
• Recurrent acute otitis media

Approved in European Union as Tympanostomy Tubes for:

• Chronic otitis media with effusion
• Recurrent acute otitis media
• Middle ear infections

Approved in Canada as Tympanostomy Tubes for:

• Middle ear infections
• Chronic otitis media with effusion
• Recurrent acute otitis media

Who Is Running the Clinical Trial?

David Chi, MD

Lead Sponsor

Trials

4

Recruited

950+

Published Research Related to This Trial

In a study of 239 children with tympanostomy tubes, complications were relatively rare, with only 0.8% experiencing otorrhea and 20.2% developing tympanosclerosis, while no cases of cholesteatoma were reported.

Post-surgery, 93.4% of patients showed improved hearing, indicating that tympanostomy tube insertion is generally effective in enhancing auditory function, despite some complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up of 366 ears after tympanostomy tube insertion: why is it draining? Kalcioglu, MT., Cokkeser, Y., Kizilay, A., et al.[2022]

In a study of 10 patients over an average follow-up of 23 months, the Tube Extender effectively addressed issues like tube retraction and exposure, leading to significant reductions in intraocular pressure and the number of glaucoma medications needed post-surgery.

All patients achieved surgical success with the Tube Extender, demonstrating its utility in lengthening glaucoma drainage implants from various manufacturers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tube extender for revision of glaucoma drainage implants. Sarkisian, SR., Netland, PA.[2007]

In a prospective, randomized study of four types of tympanostomy tubes involving an average follow-up of 17 months, the Shepard and Armstrong tubes demonstrated the lowest rates of complications such as plugging and otorrhea, with extrusion times averaging less than 1 year.

The Reuter-Bobbin tube had a higher rate of plugging, while the Goode T-tube was associated with increased otorrhea, persistence in the tympanic membrane beyond 1 year, and residual perforations, indicating it may be less favorable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized study of four commonly used tympanostomy tubes. Weigel, MT., Parker, MY., Goldsmith, MM., et al.[2007]

In a study of 507 patients who received Armstrong beveled grommet tympanostomy tubes, the average time to tube extrusion was about 16.5 months, indicating a predictable duration of effectiveness for these tubes.

The complication rates were low, with only 1.32% of patients experiencing unresolved perforations and no new cases of cholesteatoma associated with the tubes, suggesting that Armstrong tubes are a safe option for ventilation in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of Armstrong beveled grommet tympanostomy tubes in children. Lindstrom, DR., Reuben, B., Jacobson, K., et al.[2004]

Oral amoxicillin clavulanate significantly reduced the duration of ear discharge in children with grommets, with an odds ratio of 0.19 for discharge persisting after eight days, indicating it may be an effective treatment option.

The review found insufficient high-quality evidence to determine the best non-surgical management for ear discharge, highlighting the need for further research to compare the effectiveness and risks of oral versus topical antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for ear discharge associated with grommets (ventilation tubes). Vaile, L., Williamson, T., Waddell, A., et al.[2018]

Younger patients (average age 48.2 years) are at a higher risk for tube exposure after glaucoma drainage implant surgery compared to older patients (average age 67.3 years), indicating age is a significant risk factor.

Inflammation prior to tube exposure is a major risk factor for complications, with statistical significance in both univariate and multivariate analyses, highlighting the importance of managing inflammation in patients undergoing this surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for tube exposure as a late complication of glaucoma drainage implant surgery. Chaku, M., Netland, PA., Ishida, K., et al.[2022]

Oral amoxicillin clavulanate significantly reduced the duration of ear discharge in children with grommets, showing a 81% lower odds of persistent discharge compared to placebo, but this finding is based on a single study with 79 participants.

There is currently insufficient high-quality evidence to determine the best non-surgical treatment for ear discharge with grommets, highlighting the need for further research to compare the effectiveness and risks of oral versus topical antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Interventions for ear discharge associated with grommets (ventilation tubes). Vaile, L., Williamson, T., Waddell, A., et al.[2020]

A Cochrane review found that inserting ventilation tubes (grommets) in children with recurrent acute otitis media reduced the number of ear infections by about one episode in the first six months, based on two studies with 148 participants.

Additional analysis of three excluded studies showed similar results, but clinicians are advised to weigh the potential adverse effects of grommet insertion before proceeding with the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Grommets (ventilation tubes) for recurrent acute otitis media in children--assessment of a Cochrane review]. Lous, J., Trankjaer, CR., Thomsen, J.[2010]

Tympanostomy tubes primarily facilitate ventilation in the middle ear rather than drainage, as shown in a model study.

Patients with tympanostomy tubes do not need to be overly cautious about water exposure, suggesting a lower risk of complications related to water contact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patency of the tympanic tubes]. Wachsmuth, C.[2006]

In a study of 75 children followed for up to 38 months after tympanostomy tube (TT) insertion, otorrhea was the most common complication, occurring in 47.3% of ears, while other complications included tympanosclerosis (23.3%) and retractions (39.7%).

The study found that TT insertion combined with adenoidectomy led to fewer episodes of otorrhea, and younger children at the time of initial tube placement were more likely to need a second set of tubes, indicating that age and surgical strategy can influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tympanostomy tube sequelae in children with otitis media with effusion: a three-year follow-up study. Pereira, MB., Pereira, DR., Costa, SS.[2022]

A new technique using angiocatheter material to extend the tube of a glaucoma drainage implant was successfully applied in four patients, preventing the need for more invasive surgery.

All patients experienced no postoperative complications, and the average intraocular pressure (IOP) after the procedure was a healthy 11.5 mmHg, indicating the effectiveness of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of another modality for extending glaucoma drainage tubes. Smith, MF., Doyle, JW.[2006]

The case study describes a minimally invasive suture technique for repositioning the Ahmed glaucoma valve, which helps maintain stability in the anterior chamber during the procedure.

This technique, referred to as tube endothelial touch, offers a safer alternative for patients undergoing glaucoma surgery by reducing potential complications associated with more invasive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microinvasive technique for management of corneal edema secondary to glaucoma drainage device tube-corneal touch. Kumar, H., Gupta, A., Gupta, V.[2018]

A new technique using a transcameral suture effectively corrected the position of a glaucoma drainage device tube that was touching the corneal endothelium, ensuring it was at a safe distance from both the cornea and iris.

This method proved to be safe, quick, and minimally invasive, with successful results maintained over a follow-up period of 20 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcameral suture to prevent tube-corneal touch after glaucoma drainage device implantation: a new surgical technique. Bochmann, F., Azuara-Blanco, A.[2021]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28562283/

Effectiveness of Tympanostomy Tubes for Otitis Media

Tympanostomy tubes improve hearing at 1 to 3 months compared with watchful waiting, with no evidence of benefit by 12 to 24 months.

2.

publications.aap.org

publications.aap.org/pediatrics/article/139/6/e20170125/38698/Effectiveness-of-Tympanostomy-Tubes-for-Otitis

Effectiveness of Tympanostomy Tubes for Otitis Media

Tympanostomy tubes improve hearing at 1 to 3 months compared with watchful waiting, with no evidence of benefit by 12 to 24 months.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9647717/

An Overview of the Tympanostomy Tube - PMC

These tympanostomy tubes provide ventilation, equalize pressure in the middle ear, and prevent further recurrent infections. Different types ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587625000370

Preventing unnecessary tympanostomy tube placement in ...

Another study found that tympanostomy tubes may increase the risk of long-term reduced hearing and tympanic membrane abnormalities compared to medical treatment ...

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aao-hnsfjournals.onlinelibrary.wiley.com

aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599813487302

Clinical Practice Guideline: Tympanostomy Tubes in Children

Placement of tympanostomy tubes significantly improves hearing, reduces effusion prevalence, may reduce the incidence of recurrent acute otitis ...

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mayoclinic.org

mayoclinic.org/tests-procedures/ear-tubes/about/pac-20384667

Ear tubes

Tympanostomy tubes​​ Surgeons place them into the eardrums during surgery. The tube makes an airway that keeps fluid from building up behind the ...

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ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK565858/

Tympanostomy Tube Insertion - StatPearls - NCBI Bookshelf

Tympanostomy tubes improve hearing and reduce the risk of long-term complications by ventilating the middle ear and promoting fluid drainage.