Airway Ultrasound Prediction and Correlation

NCT03313947 | Withdrawn

• 1 other identifier: IRB17-00436
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Difficult Airway

Outcome Measures

Primary Outcomes (1)

• Hyo-mental distance

  The distance from the hyoid bone to the mentum to predict difficult airway.

  5 minutes before surgery starts

Secondary Outcomes (3)

• Tongue width

  5 minutes after being intubated in surgery

• Tonsil size

  5 minutes after being intubated in surgery

• Questionnaire

  30 minutes before surgery

Study Arms (3)

Difficult Airway

OTHER

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

Obstructive Sleep Apnea

OTHER

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

Predictive Obstructive Sleep Apnea

OTHER

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

Other: Questionnaire

Interventions

Ultrasound PROCEDURE

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).

Difficult Airway; Obstructive Sleep Apnea

Questionnaire OTHER

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

Predictive Obstructive Sleep Apnea

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Parent/ patient refusal to participate in study

Sponsors & Collaborators

• Vidya Raman: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

High-Energy Shock Waves; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 18, 2017
• Study Start: March 25, 2020
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (1)