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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ultrasound; Arterial Catheterization
• Intervention / Treatment: Procedure: Modified dynamic needle tip positioning under ultrasound-guidance; Procedure: Long-axis technique

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
2. Requires invasive arterial blood pressure monitoring;
3. New York Heart Association(NYHA) classification I, II or III;
4. The American Society of Anesthesiologists (ASA) classification I, II or III;
5. Patients older than 18 years and younger than 85 years (Adult);
6. Patients signed the informed consent before the study.

Exclusion Criteria:

1. Patients with hemodynamically unstable (systolic blood pressure 60 or less);
2. Patients with abnormal results of the modified Allen test;
3. Patients with ulnar artery occlusion;
4. Patients with coagulation disorders;
5. Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
6. Patients with raynaud disease and prevalent atherosclerosis;
7. Patients with history of hand or wrist trauma or surgery;
8. Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side;
9. Patients with BMI more than 40 kg/m2;
10. Patients who have participated in other relevant clinical studies within 3 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Meng Lv, doctor, Jinan, Shandong Province, China, 250000

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: YXLL-KY-2022(104)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No