Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196749
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-12-25
Brief Title:
Ultrasound-Guided Technique in Distal Radial Artery Catheterization Study
Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Organization:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization Anticipated results suggest that the improved ultrasound dynamic needle tip positioning method will surpass tactile guidance in terms of the success rate of the first puncture attempt as well as overall puncture and catheterization success rates
Detailed Description:
The distal radial artery access route has several advantages however it comes with drawbacks like tortuous anatomy and a smaller lumen diameter Compared to the wrist radial artery approach it is more prone to spasm and has a lower success rate for puncture and catheterization This clinical study aims to explore the effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization
In this prospective randomized single-center study we will enroll 112 patients scheduled for percutaneous coronary angiography They will be randomly assigned to either the control group 56 cases or the study group 56 cases using digital odd-even randomization The control group will undergo conventional tactile guidance while the study group will be guided by the improved ultrasound dynamic needle tip positioning method
Parameters to be compared between the two groups include the success rate of the first puncture attempt overall puncture success rate number of puncture attempts success rate of catheterization time to successful catheterization proportion of sheath sizes used incidence of hematoma and incidence of radial artery occlusion 24 hours post-procedure The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt overall puncture success rate and catheterization success rate while reducing the number of puncture attempts and operation time
In this prospective randomized single-center study we will enroll 112 patients scheduled for percutaneous coronary angiography They will be randomly assigned to either the control group 56 cases or the study group 56 cases using digital odd-even randomization The control group will undergo conventional tactile guidance while the study group will be guided by the improved ultrasound dynamic needle tip positioning method
Parameters to be compared between the two groups include the success rate of the first puncture attempt overall puncture success rate number of puncture attempts success rate of catheterization time to successful catheterization proportion of sheath sizes used incidence of hematoma and incidence of radial artery occlusion 24 hours post-procedure The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt overall puncture success rate and catheterization success rate while reducing the number of puncture attempts and operation time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None