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. Identifier: NCT01965457
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Ohad Ronen, Carmel Medical Center

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.

Condition or disease
Obstructive Sleep Apnea Nasal Obstruction

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Adenoid Size Assessment [ Time Frame: baseline ]
    Adenoid size assessment through a questionaire, physical exam, fiberoptic examination and lateral cervical radiographs.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients aged 2-18 with suspected adenoid hypertrophy

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01965457

Armon Clinic
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Principal Investigator: Raanan Cohen-Kerem, Md Carmel Medical Center, Haifa

Responsible Party: Ohad Ronen, Senior Physician, Carmel Medical Center Identifier: NCT01965457     History of Changes
Other Study ID Numbers: AdeQ
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Ohad Ronen, Carmel Medical Center:
obstructive sleep apnea
adenoid hypertrophy

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nasal Obstruction
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Otorhinolaryngologic Diseases