An interventional study of Ultrasound and Questionnaire in Obstructive Sleep Apnea and Difficult Airway, sponsored by Vidya Raman. Withdrawn at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by Vidya Raman · Not applicable, Interventional, and Diagnostic
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →Vidya Raman is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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
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: 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
Hyo-mental distance
The distance from the hyoid bone to the mentum to predict difficult airway.
Time frame: 5 minutes before surgery starts
Tongue width
Width of the tongue between the lingual arteries.
Time frame: 5 minutes after being intubated in surgery
Tonsil size
Size of tonsil (bilateral)
Time frame: 5 minutes after being intubated in surgery
Questionnaire
6 predictive OSA questions
Time frame: 30 minutes before surgery
Ran from Mar 2020 to primary completion in Mar 2020, 0 months.
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This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Vidya Raman