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Ultrasound-guided radial artery catheterization technique comparison in elderly patients over 70 years of age : ultrasound-guided dynamic needle tip radial artery cannulation technique(Group D) versus ultrasound-guided posterior wall puncture technique(Group P)

Status Approved

First Submitted Date

2019/08/19
Registered Date

2019/08/21
Last Updated Date

2019/08/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004232
Unique Protocol ID	2019-04-020-004
Public/Brief Title	Ultrasound-guided radial artery catheterization technique comparison in elderly patients over 70 years of age
Scientific Title	Ultrasound-guided radial artery catheterization technique comparison in elderly patients over 70 years of age : ultrasound-guided dynamic needle tip radial artery cannulation technique(Group D) versus ultrasound-guided posterior wall puncture technique(Group P)
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC-2019-04-020-004
Approval Date	2019-06-28
Institutional Review Board Name	Kangbuk samsung hospital IRB
Institutional Review Board Address	29, Saemunan-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-2001-2709
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jin hee Ahn
Title	M.D.
Telephone	+82-2-2001-2321
Affiliation	Samsung Medical Center
Address	Kangbuk samsung hospital
Contact Person for Public Queries
Name	Jin hee Ahn
Title	M.D.
Telephone	+82-2-2001-2321
Affiliation	Samsung Medical Center
Address	samunanro 29, Kangbuk samsung hospital
Contact Person for Updating Information
Name	Jin hee Ahn
Title	M.D.
Telephone	+82-2-2001-2321
Affiliation	Samsung Medical Center
Address	samunanro 29, Kangbuk samsung hospital

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-09-02 Anticipated
Target Number of Participant	152
Primary Completion Date	2020-08-01 , Anticipated
Study Completion Date	2020-08-02 , Anticipated
Name of Study	Kangbuk Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-09-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kangbuk Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kangbuk Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	In order to measure blood pressure continuously during the operation, the radial artery is placed on the surface of the skin, the blood supply to the hand is the dual blood supply, and the blood vessel is the most commonly selected because of its relatively low complication rate. In the palpation method, which confirms the pulsatility of the radial artery during the patency of the pulmonary artery, the ultrasound guided method has recently been used to confirm the position of the blood vessel using ultrasound. As age increases, atherosclerotic changes and tortuous changes in blood vessels make cannulation difficult. This study was planned because of the lack of studies comparing dynamic needle tip guidance in the ultrasound guided short axis view and posterior technique after puncture in radial artery in single view in elderly patients over 70 years of age .

Study Summary Information

Lay Summary

In order to measure blood pressure continuously during the operation, the radial artery is placed on the surface of the skin, the blood supply to the hand is the dual blood supply, and the blood vessel is the most commonly selected because of its relatively low complication rate.
In the palpation method, which confirms the pulsatility of the radial artery during the patency of the pulmonary artery, the ultrasound guided method has recently been used to confirm the position of the blood vessel using ultrasound.
As age increases, atherosclerotic changes and tortuous changes in blood vessels make cannulation difficult. This study was planned because of the lack of studies comparing dynamic needle tip guidance in the ultrasound guided short axis view and posterior technique after puncture in radial artery in single view in elderly patients over 70 years of age .

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Group D is a method of identifying the presence of the needle tip in the blood vessel using ultrasound, and positioning the needle tip in the blood vessel under an ultrasound guide. Group P is a method of locating an intravascular tube as the needle tip penetrates into the center of the vessel and then retracts and slides into the vessel.
Number of Arms	2
Arm 1	Arm Label Group D(Dynamic needle tip technique)
	Target Number of Participant 76
	Arm Type Experimental
	Arm Description Step 1: Check the needle tip in the radial artery central portion of the short axis view. Step 2: After withdrawal of the Sono probe, enter the needle and check the needle tip again. Repeat Step 1 and Step 2 to position the catheter all the way to the end.
Arm 2	Arm Label Group P(Posterior wall puncture technique )
	Target Number of Participant 76
	Arm Type Active comparator
	Arm Description Step 1: In the short axis view, the radial artery central portion puncture Step 2: After confirming the posterior puncture of the radial artery, the syringe is regurgitated and the intravenous catheter is positioned Step 3: Enter the catheter.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc radial artery cannulation
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 70Year~100Year
	Description 1) American society of anesthesiologist physical status classification I-IV (age 70+) 2) Patients scheduled for surgery under general anesthesia + continuous arterial blood pressure monitoring
Exclusion Criteria	) less than 70years 2) Abnormalities on Allen test 3) Patients with vascular malformations 4) Patients with unstable hemodynamic signs 5) Patients with skin erosion 6) Emergency surgery
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Time(Ultrasonic location time, cannulation time)
Timepoint	from cannulation to completion
Secondary Outcome(s) 1
Outcome	complication(Thrombosis / Hematoma / Edema / Vasospasm)
Timepoint	after cannulation
Secondary Outcome(s) 2
Outcome	Radial artery cannulation condition score
Timepoint	Before and after cannulation

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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