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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687370
• Other study ID #: YXLL-KY-2022(104)
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: March 26, 2023

Study information

• Verified date: March 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 26, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Catheterization
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Ultrasound

Intervention

Procedure:
• Modified dynamic needle tip positioning under ultrasound-guidance
The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.
• Long-axis technique
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to first puncture of the artery		Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds
Secondary	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
Secondary	Number of puncture attempts		Up to 5 times, an expected average observation time of 70 seconds
Secondary	Vascular complications in the surgery	including thrombosis, hematoma, and vasospasm	postoperative, within 24 hours