Clinical trial NCT05687370: Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Arterial Catheterization
Coronary Artery Disease
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Success rate of the radial artery cannulation at first attempt
timeFrame: intraoperative
Secondary outcomes:
measure: Time of arterial catheterization
timeFrame: 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
measure: Time to first puncture of the artery
timeFrame: Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds
measure: Time ultrasound imaging
timeFrame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds
measure: Number of puncture attempts
timeFrame: Up to 5 times, an expected average observation time of 70 seconds
measure: Vascular complications in the surgery
timeFrame: postoperative, within 24 hours
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Jinan, Shandong Province, China, 250000
name: Meng Lv, doctor
role: PRINCIPAL_INVESTIGATOR
References: