Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization
NCT ID: NCT06345131
Last Updated: 2024-04-03
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-07-01
2024-09-30
Brief Summary
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Detailed Description
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A total of 100 surgical patients were included. Ultrasound was used to measure the transverse diameter (TDA) of the radial artery, the vertical distance (VDA) between the radial artery (center) and the skin, and the distance (D) between the superficial branch of the radial nerve and the radial artery at the midpoint between the radial styloid process point, 2.5cm, 5cm, 7.5cm, 10cm from the radial styloid process point, 2.5cm below the center of the elbow fossa, and 10cm from the radial styloid process point and 2.5cm below the center of the elbow fossa. The radial artery was compared on both sides of the patient, as well as on different genders and ages Differences in anatomical parameters and spatial relationships of the radial nerve. Patients were randomly divided into a distal group (Group A, 33 cases), a mid distal group (Group B, 33 cases), and a proximal group (Group C, 33 cases). Group A underwent radial artery puncture and catheterization within 0-5cm of the proximal end of the radial styloid process; Group B underwent radial artery puncture and catheterization within 5-10cm of the proximal end of the radial styloid process; Group C underwent radial artery puncture and catheterization within a range of 10cm proximal to the styloid process of the radius and 2.5cm below the center of the cubital fossa. The success rate, puncture time, puncture frequency, and puncture related complications of the first ultrasound-guided radial artery puncture and catheterization were recorded for three groups of patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Transverse diameter of radial artery (TDA)
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
Non invasive blood pressure monitoring
Non invasive blood pressure monitoring
vertical distance of radial artery (center) from skin (VDA)
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
Non invasive blood pressure monitoring
Non invasive blood pressure monitoring
distance of superficial branch of radial nerve relative to horizontal position of radial artery (D)
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
Non invasive blood pressure monitoring
Non invasive blood pressure monitoring
Interventions
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Non invasive blood pressure monitoring
Non invasive blood pressure monitoring
Eligibility Criteria
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Inclusion Criteria
2. ASA grading I to II
3. Age 18-65
4. Agree to participate in this clinical study and sign an informed consent form
Exclusion Criteria
2. Peripheral vascular diseases
3. Coronary artery related diseases
4. Local skin infections, ulcers, scars, and surgical history
5. Shock patients or receiving cardiac stimulants, vasoconstrictors, etc
6. Peripheral nerve injury, anatomical abnormalities, and neurological dysfunction
7. Passive upper limb position, unable to cooperate in completing ultrasound assessment
18 Years
65 Years
ALL
Yes
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Liu Han
associate professor
Principal Investigators
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Han Liu
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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KY20230829-06
Identifier Type: -
Identifier Source: org_study_id
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