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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Measure the anatomical parameters of the radial artery and radial nerve in the forearm using ultrasound, summarize the relevant anatomical factors that affect the placement of radial artery catheterization, and find the optimal puncture range that is both safe and accurate for radial artery catheterization.

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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Surgical Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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

Group Type OTHER

Non invasive blood pressure monitoring

Intervention Type OTHER

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

Group Type OTHER

Non invasive blood pressure monitoring

Intervention Type OTHER

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

Group Type OTHER

Non invasive blood pressure monitoring

Intervention Type OTHER

Non invasive blood pressure monitoring

Interventions

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Non invasive blood pressure monitoring

Non invasive blood pressure monitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Selected surgical patients planning to undergo general anesthesia and invasive arterial blood pressure monitoring
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

1. Patients with positive or suspected positive Allen test
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Liu Han

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Han Liu, MD

Role: CONTACT

18951670163

Han Liu

Role: CONTACT

18951670163

Facility Contacts

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Liu Han, MD

Role: primary

18951670163

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.

Reference Type BACKGROUND
PMID: 36200379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30893349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35470717 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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KY20230829-06

Identifier Type: -

Identifier Source: org_study_id

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