Airway Ultrasound Prediction and Correlation

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03313947
• Other study ID #: IRB17-00436
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: March 25, 2020

Study information

• Verified date: April 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Vidya Raman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyo-mental distance	The distance from the hyoid bone to the mentum to predict difficult airway.	5 minutes before surgery starts
Secondary	Tongue width	Width of the tongue between the lingual arteries.	5 minutes after being intubated in surgery
Secondary	Tonsil size	Size of tonsil (bilateral)	5 minutes after being intubated in surgery
Secondary	Questionnaire	6 predictive OSA questions	30 minutes before surgery