Back to resultsAirway Ultrasound Prediction and Correlation
Primary Purpose
Obstructive Sleep Apnea, Difficult Airway
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Difficult Airway
Obstructive Sleep Apnea
Predictive Obstructive Sleep Apnea
Arm Description
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).
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).
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
Outcomes
Primary Outcome Measures
Hyo-mental distance
The distance from the hyoid bone to the mentum to predict difficult airway.
Secondary Outcome Measures
Tongue width
Width of the tongue between the lingual arteries.
Tonsil size
Size of tonsil (bilateral)
Questionnaire
6 predictive OSA questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03313947
Brief Title
Airway Ultrasound Prediction and Correlation
Official Title
Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI was unable to perform ultrasound of airway.
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vidya Raman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Difficult Airway
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Difficult Airway
Arm Type
Other
Arm Description
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).
Arm Title
Obstructive Sleep Apnea
Arm Type
Other
Arm Description
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).
Arm Title
Predictive Obstructive Sleep Apnea
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
Hyo-mental distance
Description
The distance from the hyoid bone to the mentum to predict difficult airway.
Time Frame
5 minutes before surgery starts
Secondary Outcome Measure Information:
Title
Tongue width
Description
Width of the tongue between the lingual arteries.
Time Frame
5 minutes after being intubated in surgery
Title
Tonsil size
Description
Size of tonsil (bilateral)
Time Frame
5 minutes after being intubated in surgery
Title
Questionnaire
Description
6 predictive OSA questions
Time Frame
30 minutes before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
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Airway Ultrasound Prediction and Correlation
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