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

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Nasal Obstruction

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Armon Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients aged 2-18 with suspected adenoid hypertrophy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoid Size Assessment	Adenoid size assessment through a questionaire, physical exam, fiberoptic examination and lateral cervical radiographs.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of lateral cervical radiographs and fiberoptic exams	A measurement of cases that the exam was not possible to perform or was not in good quality will be done.	baseline

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Raanan Cohen-Kerem, Md, Carmel Medical Center, Haifa

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pediatric; obstructive sleep apnea; adenoid hypertrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nasal Obstruction
• Other Study ID Numbers: AdeQ