Measurement of Cut-off Perfusion Index Value in Infraclav... | NCT05234541

Studies
Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks

NCT05234541

Sponsor

Adiyaman University

Status

Unknown status

Last Update Posted

Feb 10, 2022Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Upper Extremity Surgery

Interventions

Not provided

Countries

Turkey (Türkiye)

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

ID	Type	Description	Link
ISEYHANLI	Other Identifier	AdiyamanU

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Apr 15, 2022Estimated

Completion Date

Nov 15, 2022Estimated

First Submitted Date

Feb 1, 2022

First Submission Date that Met QC Criteria

Feb 1, 2022

First Posted Date

Feb 10, 2022Actual

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 1, 2022

Last Update Posted Date

Feb 10, 2022Actual

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

To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.

Detailed Description

In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance	To measure perfusion index values in patients aged 18-65 years who underwent upper extremity surgery	Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-2 PATIENTS
PATIENTS BETWEEN 18-65 YEARS
PATIENTS WITH INFRACLAVICULAR BLOCK

Exclusion Criteria:

ASA3-4 PATIENTS
PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65
PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY
PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK
PATIENTS WITHOUT COOPERATION
PATIENTS WITH DIABETES MELLITUS
THOSE WHO HAVE PERIPHERAL ARTERY DISEASE

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

ASA1-2 50 PATIENTS BETWEEN 18-65 YEARS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adıyaman University Recruitment		Adıyaman			Turkey (Türkiye)