The Evaluation of Airway Dimension by Using Ultrasonography | NCT04175483

Studies
The Evaluation of Airway Dimension by Using Ultrasonography

NCT04175483

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 4, 2020Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Subglottic Airway Diameter in Normal Adults

Interventions

assessment of subglottic diameter by ultrasonography

Countries

Taiwan

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Aug 31, 2020Estimated

First Submitted Date

Nov 21, 2019

First Submission Date that Met QC Criteria

Nov 21, 2019

First Posted Date

Nov 25, 2019Actual

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

Aug 2, 2020

Last Update Posted Date

Aug 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of this study is to measure the dimension of airway in healthy Asian population. We recruit normal volunteer subjects aged more than 20 years old. Subglottic transverse diameter is measured and recorded by ultrasonography.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
assessment of subglottic diameter by ultrasonography	Other	assessment of subglottic diameter by ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
transverse glottic diameter by ultrasonography	transverse glottic diameter by ultrasonography	one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult healthy volunteers (aged more than 20 years) without pre-existing airway or respiratory diseases, neck tumors and a history of neck operation.

Exclusion Criteria:

pre-existing airway or respiratory diseases, neck tumors and a history of neck operation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult healthy volunteers (aged more than 20 years) without pre-existing airway or respiratory diseases, neck tumors and a history of neck operation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wan-Ching Lien, ph.D.	Contact	+886-2-2312345	62831	wanchinglien@ntu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wan-Ching Lien	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided