Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy

Summary

Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in breathing during sleep. It affects at least 1-3% of the general pediatric population with greater prevalence among certain high risk groups such as children with obesity, Down syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown that, even after having adenotonsillectomy (AT), approximately 30% of children continue to struggle with OSA. They further found that older children (age \> 7 yrs), obesity, and high pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these known risk factors, the ability to predict each individual patient's risk of residual OSA after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an important step towards more effective post-surgery OSA management.

The purpose of this study is to determine whether sleep endoscopy can predict whether their AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple areas of obstruction in addition to large tonsils will be more likely to have residual OSA after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves passing a flexible endoscope through the subject's nose into the back of the throat to look for sources of obstruction while breathing spontaneously.

This will be a prospective cohort study examining subjects between the ages of 2 and 18 who are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for residual OSA after surgery. High risk will be defined based on the following criteria: obesity, Down syndrome, African American race, severe baseline OSA, and age \> 7 yrs. Eligible subjects will be recruited from the pediatric otolaryngology clinic at the time of initial evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the time of AT. All patients will be asked to complete a preoperative sleep study to confirm the diagnosis of OSA and a postoperative sleep study to determine the impact of AT and the presence of residual OSA. Secondary outcome measures will include several questionnaires assessing generic and OSA-specific quality of life as well as subjective measures of cognitive/executive functioning and daytime sleepiness.

Conditions

• Obstructive Sleep Apnea

Interventions

PROCEDURE

Sleep Endoscopy

Sleep endoscopy will be performed prior to the adenotonsillectomy, under the same general anesthetic. The endoscopy will be performed using a flexible fiber optic endoscope which will be advanced trans nasally into the pharynx down to the level of the hypopharynx. We will take note of any obvious septal deviation or nasal obstruction as well as adenoid hypertrophy, and dynamic collapse at the level of the velum, oropharynx/lateral walls, tongue base, epiglottis, and supraglottis. Relatively fixed structures such as the nasal airway and adenoids should require 1 minute to fully assess. The endoscope will then be held for 2 minutes of observation above each subsequent site of potential dynamic airway collapse (the velum, oropharynx/lateral walls, tongue base, epiglottis/supraglottis).

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Derek Lam, MD, MPH · Oregon Health and Science University

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-01

Primary Completion

2022-11-09

Completion

2023-03-31

Countries

• United States

Study Locations