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

NCT ID: NCT05687370

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-03-26

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.

Conditions

Ultrasound; Arterial Catheterization; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Modified dynamic needle tip positioning under ultrasound-guidance

Intervention Type: PROCEDURE

The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.

Long-axis in-plane technique

Group Type: ACTIVE_COMPARATOR

Long-axis technique

Intervention Type: PROCEDURE

The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Interventions

Modified dynamic needle tip positioning under ultrasound-guidance

The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.

Intervention Type: PROCEDURE

Long-axis technique

The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meng Lv

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meng Lv, doctor

Role: PRINCIPAL_INVESTIGATOR

Jinan, Shandong Province, China, 250000

Locations

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

YXLL-KY-2022(104)

Identifier Type: -

Identifier Source: org_study_id