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

NCT05687370 | Completed

• 1 other identifier: YXLL-KY-2022(104)
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  postoperative, within 24 hours

Study Arms (2)

Modified dynamic needle tip positioning technique

ACTIVE COMPARATOR

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

Long-axis in-plane technique

ACTIVE COMPARATOR

Procedure: Long-axis technique

Interventions

Modified dynamic needle tip positioning under ultrasound-guidance PROCEDURE

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

Modified dynamic needle tip positioning technique

Long-axis technique PROCEDURE

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

Long-axis in-plane technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Meng Lv, doctor

  Jinan, Shandong Province, China, 250000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: January 18, 2023
• Study Start: January 15, 2023
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)