Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01965457|
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : January 25, 2018
The term adenoids describes lymphoid tissue on the superior and posterior walls of the nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged, adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice, and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease. Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through Eustachian tube dysfunction or chronic adenoidal infection.
Methods for identification of adenoid hypertrophy include the clinical history, examination, imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of the nasal cavity with dynamic evaluation of any nasal airway obstruction.
The aim of this study is to prospectively examine invasive and non-invasive office procedures to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal endoscopy.
Prospective, observational study in pediatric patients aged 2-18 that will be referred to the otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed consent.
- Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will be evaluated at the clinic, as described by Paradise grading system.
- Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the patients had them at the time of referral. Adenoidal obstruction will be assessed by Fujioka's Adenoid-Nasopharynx ratio.
- Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be assessed by Parikh grading system.
|Condition or disease|
|Obstructive Sleep Apnea Nasal Obstruction|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings|
|Actual Study Start Date :||September 2013|
|Primary Completion Date :||September 2017|
|Study Completion Date :||September 2017|
- Adenoid Size Assessment [ Time Frame: baseline ]Adenoid size assessment through a questionaire, physical exam, fiberoptic examination and lateral cervical radiographs.
- Efficacy of lateral cervical radiographs and fiberoptic exams [ Time Frame: baseline ]A measurement of cases that the exam was not possible to perform or was not in good quality will be done.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965457
|Principal Investigator:||Raanan Cohen-Kerem, Md||Carmel Medical Center, Haifa|