Back to resultsModified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
Primary Purpose
Ultrasound, Arterial Catheterization, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified dynamic needle tip positioning under ultrasound-guidance
Long-axis technique
Sponsored by
About this trial
This is an interventional other trial for Ultrasound
Eligibility Criteria
Inclusion Criteria: The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10); Requires invasive arterial blood pressure monitoring; New York Heart Association(NYHA) classification I, II or III; The American Society of Anesthesiologists (ASA) classification I, II or III; Patients older than 18 years and younger than 85 years (Adult); Patients signed the informed consent before the study. Exclusion Criteria: Patients with hemodynamically unstable (systolic blood pressure 60 or less); Patients with abnormal results of the modified Allen test; Patients with ulnar artery occlusion; Patients with coagulation disorders; Patients with skin abnormalities such as inflammation or hematoma at the cannulation site; Patients with raynaud disease and prevalent atherosclerosis; Patients with history of hand or wrist trauma or surgery; Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side; Patients with BMI more than 40 kg/m2; Patients who have participated in other relevant clinical studies within 3 months.
Sites / Locations
- Shandong Provincial Qianfoshan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Modified dynamic needle tip positioning technique
Long-axis in-plane technique
Arm Description
In Modified dynamic needle tip positioning technique, short-axis in-plane is used, needle tip was dynamic guided by ultrasound that added two developing lines on the ultrasonic probe.
Outcomes
Primary Outcome Measures
Success rate of the radial artery cannulation at first attempt
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
Secondary Outcome Measures
Time of arterial catheterization
Time to first puncture of the artery
Time ultrasound imaging
Number of puncture attempts
Vascular complications in the surgery
including thrombosis, hematoma, and vasospasm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687370
Brief Title
Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
Official Title
Modified Dynamic Needle Tip Positioning Versus Long-Axis In-Plane Ultrasound Guided Radial Artery Cannulation in Patients With Coronary Artery Disease: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
March 26, 2023 (Actual)
Study Completion Date
March 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Conventionally, long-axis in-plane (LA-IP), short-axis out-of-plane (SA-OOP) and dynamic needle tip positioning based on SA-OOP views are commonly used method to image the target vessel during cannulation under US guidance. A modified SA-OOP that add developing line on the ultrasonic probe improve the success rate of cannula insertion into the radial artery on the first attempt.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound, Arterial Catheterization, Coronary Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified dynamic needle tip positioning technique
Arm Type
Active Comparator
Arm Description
In Modified dynamic needle tip positioning technique, short-axis in-plane is used, needle tip was dynamic guided by ultrasound that added two developing lines on the ultrasonic probe.
Arm Title
Long-axis in-plane technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Modified dynamic needle tip positioning under ultrasound-guidance
Intervention Description
The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.
Intervention Type
Procedure
Intervention Name(s)
Long-axis technique
Intervention Description
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
Primary Outcome Measure Information:
Title
Success rate of the radial artery cannulation at first attempt
Description
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Time of arterial catheterization
Time Frame
Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average observation time of 300 seconds
Title
Time to first puncture of the artery
Time Frame
Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds
Title
Time ultrasound imaging
Time Frame
Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds
Title
Number of puncture attempts
Time Frame
Up to 5 times, an expected average observation time of 70 seconds
Title
Vascular complications in the surgery
Description
including thrombosis, hematoma, and vasospasm
Time Frame
postoperative, within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
Requires invasive arterial blood pressure monitoring;
New York Heart Association(NYHA) classification I, II or III;
The American Society of Anesthesiologists (ASA) classification I, II or III;
Patients older than 18 years and younger than 85 years (Adult);
Patients signed the informed consent before the study.
Exclusion Criteria:
Patients with hemodynamically unstable (systolic blood pressure 60 or less);
Patients with abnormal results of the modified Allen test;
Patients with ulnar artery occlusion;
Patients with coagulation disorders;
Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
Patients with raynaud disease and prevalent atherosclerosis;
Patients with history of hand or wrist trauma or surgery;
Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side;
Patients with BMI more than 40 kg/m2;
Patients who have participated in other relevant clinical studies within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Lv, doctor
Organizational Affiliation
Jinan, Shandong Province, China, 250000
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
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