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

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687370
Collaborator
(none)
124
2
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified dynamic needle tip positioning under ultrasound-guidance
  • Procedure: Long-axis technique
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Mar 27, 2023
Anticipated Study Completion Date :
Mar 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

Active Comparator: Long-axis in-plane technique

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. Time to first puncture of the artery [Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds]

  3. 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]

  4. Number of puncture attempts [Up to 5 times, an expected average observation time of 70 seconds]

  5. Vascular complications in the surgery [postoperative, within 24 hours]

    including thrombosis, hematoma, and vasospasm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

  • Principal Investigator: Meng Lv, doctor, Jinan, Shandong Province, China, 250000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meng Lv, Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05687370
Other Study ID Numbers:
  • YXLL-KY-2022(104)
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2023