Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ultrasound, Arterial Catheterization, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Modified dynamic needle tip positioning under ultrasound-guidance
* Procedure: Long-axis technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified dynamic needle tip positioning technique<br>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. | Procedure: Modified dynamic needle tip positioning under ultrasound-guidance<br>* The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.<br>|
| Active Comparator: Long-axis in-plane technique<br> | Procedure: Long-axis technique<br>* The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of arterial catheterization |  | 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 | 
| Time to first puncture of the artery |  | Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds | 
| Time ultrasound imaging |  | Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds | 
| Number of puncture attempts |  | Up to 5 times, an expected average observation time of 70 seconds | 
| Vascular complications in the surgery | including thrombosis, hematoma, and vasospasm | postoperative, within 24 hours |