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

NCT02227134 | Withdrawn

• 1 other identifier: IRB14-00572
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Airway; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Hyo-mental distance

  The distance from the hyoid bone to the mentum to predict difficult airway.

  intraoperative

Secondary Outcomes (2)

• Tongue width

  intraoperative

• Tonsil Size

  intraoperative

Study Arms (2)

Difficult Airway

OTHER

Children with a history of difficult airway intubation.

Procedure: Ultrasound

Obstructive Sleep Apnea

OTHER

Children with a history of obstructive sleep apnea.

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

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

Difficult Airway; Obstructive Sleep Apnea

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Parent/ patient refusal to participate in study

Sponsors & Collaborators

• Vidya Raman: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (1)