Ultrasound to Predict a Pediatric Difficult Airway and Ob... | NCT02227134

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

NCT02227134

Sponsor

Vidya Raman

Status

Withdrawn

Last Update Posted

Jul 10, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Difficult Airway
Obstructive Sleep Apnea

Interventions

Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to perform the ultrasound.

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 26, 2014

First Submission Date that Met QC Criteria

Aug 26, 2014

First Posted Date

Aug 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2020

Last Update Posted Date

Jul 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Procedure	Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.	Difficult Airway Obstructive Sleep Apnea

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided