Surgical PatientsNCT06345131
Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization
A study testing Non invasive blood pressure monitoring in people with Surgical Patients, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Patients
- What is being tested?
- Non invasive blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Liu Han, MD, 18951670163, han_cold.student@sina.com
About this study
Official title: Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery
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.
Read the detailed description
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
- Surgical Patients
- Being tested
- Non invasive blood pressure monitoring
- Keywords
- Ultrasound guidance, Radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive blood pressure monitoringOther
Non invasive blood pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Non invasive blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before anesthesia surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jul 2023
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical PatientsStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Han, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Han Liu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345131
- Sponsor's protocol ID
- KY20230829-06
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36200379Genre 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.
PubMed 30893349Maitra 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.
PubMed 35470717
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery
- ClinicalTrials.gov ID
- NCT06345131
- Acronym / sponsor ID
- KY20230829-06
- Conditions
- Surgical Patients
- Keywords
- Ultrasound guidance, Radial artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transverse diameter of radial artery (TDA) | Other | Other: Non invasive blood pressure monitoringThe 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 |
| vertical distance of radial artery (center) from skin (VDA) | Other | Other: Non invasive blood pressure monitoringThe 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 |
| distance of superficial branch of radial nerve relative to horizontal position of radial artery (D) | Other | Other: Non invasive blood pressure monitoringThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive blood pressure monitoringNon invasive blood pressure monitoring | Other | 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) |
Primary outcome
Measure the transverse diameter of the radial artery at each anatomical point
Time frame: Before anesthesia surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 36200379Gutwein 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.
- Background: PubMed 30893349Genre 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.
- Background: PubMed 35470717Maitra 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.
- Individual participant dataSharing planned: No
Related trials for Surgical Patients
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Liu study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive blood pressure monitoring in people with Surgical Patients, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Liu, MD (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the transverse diameter of the radial artery at each anatomical point (time frame: Before anesthesia surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345131, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.