Radial Artery Cannulation and Perfusion Index | NCT03845361

Studies
Radial Artery Cannulation and Perfusion Index

NCT03845361

Sponsor

Assiut University

Status

Completed

Last Update Posted

Oct 19, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Peripheral Perfusion

Interventions

Radial artery cannulation

Countries

Egypt

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 2022

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

Feb 21, 2019Actual

Primary Completion Date

Jan 21, 2021Actual

Completion Date

Feb 21, 2021Actual

First Submitted Date

Dec 25, 2018

First Submission Date that Met QC Criteria

Feb 17, 2019

First Posted Date

Feb 19, 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

Oct 18, 2022

Last Update Posted Date

Oct 19, 2022Actual

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

This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.

Detailed Description

Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.

Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.

this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C. hand	Experimental	Radial artery cannulation	Procedure: Radial artery cannulation
N.C. hand	No Intervention	No cannulation of the radial artery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radial artery cannulation	Procedure	Radial artery cannulation	C. hand

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The perfusion index		Intraoperative
The peripheral temperature		Intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

Peripheral vascular diseases
previous upper limb surgeries
planned radial artery harvesting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut		71515	Egypt

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