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Clinical Trials/NCT01965457
NCT01965457
Completed
Not Applicable

Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings

Carmel Medical Center1 site in 1 country36 target enrollmentStarted: September 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Carmel Medical Center
Enrollment
36
Locations
1
Primary Endpoint
Adenoid Size Assessment

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Adenoid Size Assessment

Time Frame: baseline

Adenoid size assessment through a questionaire, physical exam, fiberoptic examination and lateral cervical radiographs.

Secondary Outcomes

  • Efficacy of lateral cervical radiographs and fiberoptic exams(baseline)

Investigators

Sponsor
Carmel Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ohad Ronen

Senior Physician

Carmel Medical Center

Study Sites (1)

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