Back to resultsUltrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
Primary Purpose
Difficult Airway, Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Difficult Airway
Eligibility Criteria
Inclusion Criteria:
- Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.
- Children with difficult tracheal intubation aged 1 month - 18 years old
- Children with obstructive sleep apnea aged 1 year - 8 years old
Exclusion Criteria:
- Parent/ patient refusal to participate in study
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Difficult Airway
Obstructive Sleep Apnea
Arm Description
Children with a history of difficult airway intubation.
Children with a history of obstructive sleep apnea.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02227134
Brief Title
Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to perform the ultrasound.
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vidya Raman
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Airway, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group 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
Children with a history of difficult airway intubation.
Arm Title
Obstructive Sleep Apnea
Arm Type
Other
Arm Description
Children with a history of obstructive sleep apnea.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.
Primary Outcome Measure Information:
Title
Hyo-mental distance
Description
The distance from the hyoid bone to the mentum to predict difficult airway.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Tongue width
Description
Width of the tongue between the lingual arteries.
Time Frame
intraoperative
Title
Tonsil Size
Description
Size of tonsil (bilateral)
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.
Children with difficult tracheal intubation aged 1 month - 18 years old
Children with obstructive sleep apnea aged 1 year - 8 years old
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
Learn more about this trial
Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
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