Airway Ultrasound Prediction and Correlation

Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea

This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Difficult Airway
• Intervention / Treatment: Procedure: Ultrasound; Other: Questionnaire

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All children presenting for surgery at NCH ranging in age from 3-12 years

Exclusion Criteria:

• Parent/ patient refusal to participate in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Difficult Airway; Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).	Procedure: Ultrasound; Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).
Other: Obstructive Sleep Apnea; Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).	Procedure: Ultrasound; Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).
Other: Predictive Obstructive Sleep Apnea; The following 6 questions will be asked during the preoperative visit: While sleeping, does your child snore more than half the time?; While sleeping, does your child always snore?; Have you ever seen your child stop breathing during the night?; Does your child occasionally wet the bed?; Did your child stop growing at a normal rate at any time since birth?; Is your child overweight	Other: Questionnaire; The following 6 questions will be asked during the preoperative visit: While sleeping, does your child snore more than half the time?; While sleeping, does your child always snore?; Have you ever seen your child stop breathing during the night?; Does your child occasionally wet the bed?; Did your child stop growing at a normal rate at any time since birth?; Is your child overweight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyo-mental distance	The distance from the hyoid bone to the mentum to predict difficult airway.	5 minutes before surgery starts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue width	Width of the tongue between the lingual arteries.	5 minutes after being intubated in surgery
Tonsil size	Size of tonsil (bilateral)	5 minutes after being intubated in surgery
Questionnaire	6 predictive OSA questions	30 minutes before surgery

Collaborators and Investigators

• Sponsor: Vidya Raman

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: IRB17-00436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No