Anatomy and Ultrasound Evaluation for Central Venous Access | NCT03481062

Studies
Anatomy and Ultrasound Evaluation for Central Venous Access

NCT03481062

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Oct 29, 2018Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Catheterization, Central Venous; Ultrasonography

Interventions

Not provided

Countries

China

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

Oct 2018

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

Mar 1, 2018Actual

Primary Completion Date

Dec 30, 2018Estimated

Completion Date

Dec 30, 2018Estimated

First Submitted Date

Mar 22, 2018

First Submission Date that Met QC Criteria

Mar 22, 2018

First Posted Date

Mar 29, 2018Actual

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

Oct 26, 2018

Last Update Posted Date

Oct 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization.

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

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area	SV area in square centimeter	12 months
length	SV length in centimeter	12 months

Secondary Outcomes

Measure	Description	Time Frame
width	SV width in centimeter	12 months
skin distance	depth from skin in centimeter	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years old
gender unlimited
18.5 < body mass index (BMI) < 30
written consent signed.

Exclusion Criteria:

abnormality of the infraclavicular region, including infection, deformity,
history of bone, joint, muscle or neurovascular disease
history of injury, radiation or invasive procedure
subjects refused.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

adult Asian without past medical history of the infraclavicular region

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

Label	Type	Description	Intervention Names
Neutral
abduction
pad
combination