Doppler Ultrasonography Assessed Vascular Changes Before... | NCT03294993

Studies
Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture

NCT03294993

Sponsor

China Medical University, China

Status

Withdrawn

Last Update Posted

Nov 11, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Blood Flow Indexes

Interventions

Ultrasound assess

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants enrolled

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 27, 2017Actual

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

Nov 5, 2021

Last Update Posted Date

Nov 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography

Detailed Description

The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography.The indexes include Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.

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
Ultrasound assess group	Experimental	The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography	Device: Ultrasound assess

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound assess	Device	The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Change of Peak Systolic Velocity	The Change of Peak Systolic Velocity before and after surgery	baseline and 30 minutes after surgery

Secondary Outcomes

Measure	Description	Time Frame
the change of modified Allen test	the change of modified Allen test before and after surgery	baseline and 30 minutes after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II,candidates for general anesthesia undergoing thoracic surgery

Exclusion Criteria:

Patients were excluded if they do not want to cooperate with the test, had a history of upper extremity arteriosclerosis obliterans or thromboangitis obliterans,had a history of radial artery puncture or coronary artery bypass grafting,had acute vessel trauma,or had been diagnosed with Raynaud' disease,had suffered from mental or neurological disorders

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Ma, MD,PhD	Department of Anesthesiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Hospital of China Medical University		Shenyang	Liaoning	110001	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided