The Assessment of Microcirculation in Brachial Plexus Blo... | NCT02727829

Studies
The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time

NCT02727829

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Circulatory; Change

Interventions

pefusion index measurement

Countries

Not provided

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

Feb 2017

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

May 1, 2016Actual

Primary Completion Date

Oct 1, 2016Actual

Completion Date

Oct 1, 2016Actual

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Apr 5, 2016Estimated

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

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time.

Detailed Description

Microcirculation is very crucial to evaluate the organ function those working properly in human body. The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time. A total of 50 patients whose planned to underwent surgery are performed brachial plexus block using ultrasound, and pefusion index, heart rate, blood pressure, capillary filling time are measured at 0, 10th and 20th minutes interval and at postoperative 24th hours. All measures will be recorded.

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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pefusion index measurement	Device	perfusion index measurement using massimo radical 7 device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
perfusion index		five times in one year

Secondary Outcomes

Measure	Description	Time Frame
capillary filing time		five times in one year
heart rate		five times in one year
blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists score of I and III
ages between 18 and 70
upper extremity surgery

Exclusion Criteria:

not to participate in the study
reject to perform the intervention
infection in injection cite
allergy to local anesthetics
peripherical vasculary diseases
psychiatric diseases
coagulation anomalies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

American Society of Anesthesiologists score of I and III
ages between 18 and 70
upper extremity surgery

Sampling Method

Probability Sample

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