The Effect of Head and Shoulder Positioning on the Cross-... | NCT03993587

Studies
The Effect of Head and Shoulder Positioning on the Cross-sectional Area of the Subclavian Vein in Obese Adults

NCT03993587

Sponsor

SMG-SNU Boramae Medical Center

Status

Completed

Last Update Posted

Mar 29, 2021Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Normal Volunteers

Interventions

Ultrasound assessment of vessels

Countries

South Korea

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2019Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 19, 2019

First Posted Date

Jun 20, 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

Mar 25, 2021

Last Update Posted Date

Mar 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical CenterPrincipal Investigator

Lead Sponsor

SMG-SNU Boramae Medical CenterOTHER

Collaborators

Not provided

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

In the present study, the cross-sectional area of subclavian vein, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults.

Detailed Description

Not provided

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

26Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound assessment of vessels	Other	Subclavian vein and related structures are examined using ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cross-sectional area of subclavian vein	Cross-sectional area of subclavian vein is assessed.	through the completion of assessment, an average of 1 hr

Secondary Outcomes

Measure	Description	Time Frame
Depth of subclavian vein from skin	Depth of subclavian vein from skin is assessed.	through the completion of assessment, an average of 1 hr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy obese adults (BMI ≥ 30)

Exclusion Criteria:

Medication affecting vascular elasticity History of central venous catheterization or clavicle fracture History of lung surgery, operation of chest cage

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy obese adults (BMI ≥ 30)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Young Hwang, MD, PhD	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SMG-SNU Boramae Medical Center		Seoul			South Korea

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