Inferior Turbinate Reduction in Pediatric Population Failing Surgery for Sleep Disordered Breathing
NCT ID: NCT00936494
Last Updated: 2016-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2009-06-30
2011-05-31
Brief Summary
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Detailed Description
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The trial seeks to provide evidence that the treatment of inferior turbinates in patients with continued symptoms of obstructive sleep apnea, sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome after tonsillectomy and adenoidectomy will improve these symptoms and should be included in the treatment paradigm for treatment of sleep related breathing disorders in infants, children, and adolescents.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
No inferior turbinate surgery.
No interventions assigned to this group
Intervention
Intervention group: Cold ablation inferior turbinate reduction utilizing radiofrequency ablation surgery (CITR).
Cold ablation inferior turbinate reduction
The procedure usually takes 30 minutes and involves the surgeon inserting the coblation inferior turbinate reduction wand into the inferior turbinates and allowing for the radiofrequency cold ablation to ablate soft tissues, with a resultant thermal lesion allowing for additional soft tissue attenuation and contracture with time.
Interventions
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Cold ablation inferior turbinate reduction
The procedure usually takes 30 minutes and involves the surgeon inserting the coblation inferior turbinate reduction wand into the inferior turbinates and allowing for the radiofrequency cold ablation to ablate soft tissues, with a resultant thermal lesion allowing for additional soft tissue attenuation and contracture with time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Enlarged inferior turbinates with nasal obstruction (\>25%).
3. Age 0-18 years.
4. Lack of improvement of obstructive sleep apnea symptoms after maximal medical treatment with intranasal steroids in patients with symptoms of ARS and H2 blocker medication in patients with symptoms of LPR.
Exclusion Criteria
2. Patients with BMI \> 97% for age and sex.
3. Patients with craniofacial abnormalities.
4. Patients with previous airway issues, anatomic variance from normal, mallampati class III or IV, septal deviation, choanal stenosis, and nasal stenosis.
18 Years
ALL
Yes
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Principal Investigators
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Eliav Gov-Ari, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University Hospitals and Clinics
Columbia, Missouri, United States
Countries
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Other Identifiers
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1137500
Identifier Type: -
Identifier Source: org_study_id
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