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

July 8, 2020 updated by: Vidya Raman
This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Difficult Airway
Children with a history of difficult airway intubation.
Procedure: Ultrasound
Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.
Other: Obstructive Sleep Apnea
Children with a history of obstructive sleep apnea.
Procedure: Ultrasound
Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyo-mental distance
Time Frame: intraoperative
The distance from the hyoid bone to the mentum to predict difficult airway.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue width
Time Frame: intraoperative
Width of the tongue between the lingual arteries.
intraoperative
Tonsil Size
Time Frame: intraoperative
Size of tonsil (bilateral)
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vidya Raman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe