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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Ultrasound; Arterial Catheterization
• Interventions: Procedure: Modified dynamic needle tip positioning under ultrasound-guidance; Procedure: Long-axis technique

• Registration Number: NCT05687370
• Lead Sponsor: Qianfoshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-04
• Study Start: 2023-01-15
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-18
• Status Verified: 2023-03
• Primary Completion: 2023-03-26
• Study Completion: 2023-03-26
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified dynamic needle tip positioning technique	Modified dynamic needle tip positioning under ultrasound-guidance	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.
Long-axis in-plane technique	Long-axis technique	-

Primary Outcome Measures

Name	Time	Method
Success rate of the radial artery cannulation at first attempt	intraoperative	Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation

Secondary Outcome Measures

Name	Time	Method
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
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
Vascular complications in the surgery	postoperative, within 24 hours	including thrombosis, hematoma, and vasospasm

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China