Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization

NCT06345131 | Recruiting

• 1 other identifier: KY20230829-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy.

Conditions

Surgical Patients

Keywords

Ultrasound guidance; Radial artery

Outcome Measures

Primary Outcomes (1)

• Measure the transverse diameter of the radial artery at each anatomical point

  The patient is in a flat lying position, with both upper limbs abduction, palms facing upwards, and wrist joint angle of 45 °. A portable ultrasound instrument (probe frequency 13-6MHz, Sono Sound Company) is used, and the ultrasound probe is in vertical contact with the forearm in the short axis direction, Explore the relative anatomical sites of the radial artery (confirmed by Doppler) on the left and right sides of the body surface projection line of the radial artery (from 2.5cm below the center of the cubital fossa to the inner side of the radial styloid process), with a relative distance of 2cm. There is no significant compression of the radial artery during scanning to maintain the normal shape and location of the blood vessels.

  Before anesthesia surgery

Study Arms (3)

Transverse diameter of radial artery (TDA)

OTHER

The patient was placed in a supine position, the upper limb was abducted on the operative side, the palm was upward, and the wrist joint was extended at an angle of 45°.Radial artery puncture catheterization is performed within this group

Other: Non invasive blood pressure monitoring

vertical distance of radial artery (center) from skin (VDA)

OTHER

The patient was placed in a supine position, the upper limb was abducted on the operative side, the palm was upward, and the wrist joint was extended at an angle of 45°.Radial artery puncture catheterization is performed within this group

Other: Non invasive blood pressure monitoring

distance of superficial branch of radial nerve relative to horizontal position of radial artery (D)

OTHER

The patient was placed in a supine position, the upper limb was abducted on the operative side, the palm was upward, and the wrist joint was extended at an angle of 45°.Radial artery puncture catheterization is performed within this group

Other: Non invasive blood pressure monitoring

Interventions

Non invasive blood pressure monitoring OTHER

Non invasive blood pressure monitoring

Transverse diameter of radial artery (TDA); distance of superficial branch of radial nerve relative to horizontal position of radial artery (D); vertical distance of radial artery (center) from skin (VDA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Selected surgical patients planning to undergo general anesthesia and invasive arterial blood pressure monitoring
• ASA grading I to II
• Age 18-65
• Agree to participate in this clinical study and sign an informed consent form

You may not qualify if:

• Patients with positive or suspected positive Allen test
• Peripheral vascular diseases
• Coronary artery related diseases
• Local skin infections, ulcers, scars, and surgical history
• Shock patients or receiving cardiac stimulants, vasoconstrictors, etc
• Peripheral nerve injury, anatomical abnormalities, and neurological dysfunction
• Passive upper limb position, unable to cooperate in completing ultrasound assessment

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (3)

• Gutwein A, Thalhammer C. Ultrasound-guided venous pressure measurement. Vasa. 2022 Nov;51(6):333-340. doi: 10.1024/0301-1526/a001032. Epub 2022 Oct 6.

  PMID: 36200379 BACKGROUND

• Genre Grandpierre R, Bobbia X, Muller L, Markarian T, Occean BV, Pommet S, Roger C, Lefrant JY, de la Coussaye JE, Claret PG. Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial. PLoS One. 2019 Mar 20;14(3):e0213683. doi: 10.1371/journal.pone.0213683. eCollection 2019.

  PMID: 30893349 BACKGROUND

• Maitra S, Baidya DK, Ray BR, Chowhan G, Bhattacharjee S. Comparison of ultrasound guided dorsal radial artery cannulation and conventional radial artery cannulation at the volar aspect of wrist: A pilot randomized controlled trial. J Vasc Access. 2023 Nov;24(6):1463-1468. doi: 10.1177/11297298221093953. Epub 2022 Apr 26.

  PMID: 35470717 BACKGROUND

Study Officials

• Han Liu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Han Liu, MD

CONTACT

18951670163; han_cold.student@sina.com

Han Liu

CONTACT

18951670163; han_cold.student@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: April 3, 2024
• Study Start: July 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)