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NCT02227134 Clinical Trial

Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02227134
Other study ID # IRB14-00572
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date December 2020

Study information
Verified date July 2020
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound
Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.

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. intraoperative
Secondary Tongue width Width of the tongue between the lingual arteries. intraoperative
Secondary Tonsil Size Size of tonsil (bilateral) intraoperative
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