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Completed

NCT Number: NCT05687370

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

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.

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Key information

Conditions

Ultrasound Arterial Catheterization Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Modified dynamic needle tip positioning under ultrasound-guidance

Procedure

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

Long-axis technique

Procedure

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

Primary outcomes

  1. Success rate of the radial artery cannulation at first attempt

    Time frame: intraoperative

    Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation

Secondary outcomes

  1. Time of arterial catheterization

    Time frame: 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

  2. Time to first puncture of the artery

    Time frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds

  3. Time ultrasound imaging

    Time frame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds

  4. Number of puncture attempts

    Time frame: Up to 5 times, an expected average observation time of 70 seconds

  5. Vascular complications in the surgery

    Time frame: postoperative, within 24 hours

    including thrombosis, hematoma, and vasospasm

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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