Airway Ultrasound Prediction and Correlation

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea; Difficult Airway
• Interventions: Procedure: Ultrasound; Other: Questionnaire

• Registration Number: NCT03313947
• Lead Sponsor: Vidya Raman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-18
• Study Start: 2020-03-25
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Difficult Airway	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).
Obstructive Sleep Apnea	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).
Predictive Obstructive Sleep Apnea	Questionnaire	The following 6 questions will be asked during the preoperative visit: 1. While sleeping, does your child snore more than half the time? 2. While sleeping, does your child always snore? 3. Have you ever seen your child stop breathing during the night? 4. Does your child occasionally wet the bed? 5. Did your child stop growing at a normal rate at any time since birth? 6. Is your child overweight

Primary Outcome Measures

Name	Time	Method
Hyo-mental distance	5 minutes before surgery starts	The distance from the hyoid bone to the mentum to predict difficult airway.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States