Clinical trial NCT01965457: Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings
Official title: Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Nasal Obstruction
Keywords: obstructive sleep apnea
pediatric
adenoid hypertrophy
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients aged 2-18 with suspected adenoid hypertrophy

Brief summary: 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.

Objectives :

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.

Methods :

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.

1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will be evaluated at the clinic, as described by Paradise grading system.
2. 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.
3. 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.


Eligibility criteria: Inclusion Criteria:

* age 2-18
* performed lateral cervical radiograph
* nasal obstruction
* signed informed consent by caregiver

Exclusion Criteria:

* previous adenoidectomy
* recent upper airway infection
* anatomic anomaly
* allergic rhinitis
* known obstructive sleep apnea

Primary outcomes:
measure: Adenoid Size Assessment
timeFrame: baseline
Secondary outcomes:
measure: Efficacy of lateral cervical radiographs and fiberoptic exams
timeFrame: baseline
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Armon Clinic
Study officials:
affiliation: Carmel Medical Center, Haifa
name: Raanan Cohen-Kerem, Md
role: PRINCIPAL_INVESTIGATOR
References: