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Airway Ultrasound Prediction and Correlation

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313947
Enrollment
0
Registered
2017-10-18
Start date
2020-03-25
Completion date
2020-03-25
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway, Obstructive Sleep Apnea

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.

Interventions

PROCEDUREUltrasound

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).

OTHERQuestionnaire

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

Sponsors

Vidya Raman
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hyo-mental distance5 minutes before surgery startsThe distance from the hyoid bone to the mentum to predict difficult airway.

Secondary

MeasureTime frameDescription
Tongue width5 minutes after being intubated in surgeryWidth of the tongue between the lingual arteries.
Tonsil size5 minutes after being intubated in surgerySize of tonsil (bilateral)
Questionnaire30 minutes before surgery6 predictive OSA questions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026