Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)
Study Overview
Brief Summary
Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.
Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.
Detailed Description
Introduction
Otitis media with effusion (OME, "glue ear") is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low.
Methods:
Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
only surgeon knows treated side, documentation of side only visible to surgeon and investigator
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •OME on both sides measured by flat tympanometry
Exclusion Criteria
- •Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Arms & Interventions
Ear without BET
ear without BET treatment works as control
BET ear
ear with BET treatment works as intervention arm
Intervention: Balloon Eustachian Tuboplasty (BET) (Procedure)
Outcomes
Primary Outcomes
Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry)
Time Frame: up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;
Tympanometry, an objective test of middle-ear function, uses variations of air pressure in the ear canal to assess for middle ear effusion / eardrum mobility.
Secondary Outcomes
- Otoscopy score(up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively;)
Investigators
Christoph Arnoldner
Assoc. Prof. PD M.D.
Medical University of Vienna