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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Ohad Ronen, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01965457
First received: October 16, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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
Obstructive Sleep Apnea
Nasal Obstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Adenoid Size Assessment [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Adenoid size assessment through a questionaire, physical exam, fiberoptic examination and lateral cervical radiographs.


Secondary Outcome Measures:
  • Efficacy of lateral cervical radiographs and fiberoptic exams [ Time Frame: baseline ] [ Designated as safety issue: No ]
    A measurement of cases that the exam was not possible to perform or was not in good quality will be done.


Estimated Enrollment: 36
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pediatric patients aged 2-18 with suspected adenoid hypertrophy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965457

Contacts
Contact: Raana Cohen-Kerem, MD +972-4-8250279 raanan@clalit.org.il

Locations
Israel
Armon Clinic Recruiting
Haifa, Israel
Contact: Raanan Cohen-Kerem, MD    +972-4-8250279    raanan@clalit.org.il   
Principal Investigator: Raanan Cohen Kerem, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Raanan Cohen-Kerem, Md Carmel Medical Center, Haifa
  More Information

No publications provided

Responsible Party: Ohad Ronen, Senior Physician, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01965457     History of Changes
Other Study ID Numbers: AdeQ
Study First Received: October 16, 2013
Last Updated: October 17, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
obstructive sleep apnea
pediatric
adenoid hypertrophy

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

ClinicalTrials.gov processed this record on August 25, 2014