UltrasoundNCT05687370
Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation
A study testing Modified dynamic needle tip positioning under ultrasound-guidance and Long-axis technique in people with Ultrasound and Arterial Catheterization, run by Qianfoshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ultrasound, Arterial Catheterization, Coronary Artery Disease
- What is being tested?
- Modified dynamic needle tip positioning under ultrasound-guidance and Long-axis technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 26 Mar 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
- Requires invasive arterial blood pressure monitoring;
- New York Heart Association(NYHA) classification I, II or III;
- The American Society of Anesthesiologists (ASA) classification I, II or III;
- Patients older than 18 years and younger than 85 years (Adult);
- Patients signed the informed consent before the study.
Who cannot join
- Patients with hemodynamically unstable (systolic blood pressure 60 or less);
- Patients with abnormal results of the modified Allen test;
- Patients with ulnar artery occlusion;
- Patients with coagulation disorders;
- Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
- Patients with raynaud disease and prevalent atherosclerosis;
Show all 10Show fewer
- Patients with history of hand or wrist trauma or surgery;
- Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side;
- Patients with BMI more than 40 kg/m2;
- Patients who have participated in other relevant clinical studies within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Modified dynamic needle tip positioning under ultrasound-guidance, Long-axis technique
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified dynamic needle tip positioning under ultrasound-guidanceProcedure or surgery
The tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view.
Long-axis techniqueProcedure or surgery
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
| Study group | Role | What they receive |
|---|---|---|
| Modified dynamic needle tip positioning technique | Active comparator | 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. Receives: Procedure: Modified dynamic needle tip positioning under ultrasound-guidance |
| Long-axis in-plane technique | Active comparator | Not described Receives: Procedure: Long-axis technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the radial artery cannulation at first attempt
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
Measured: intraoperative
Secondary outcomes (5)
Time of arterial catheterization
Measured: 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
Time to first puncture of the artery
Measured: Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds
Time ultrasound imaging
Measured: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds
Number of puncture attempts
Measured: Up to 5 times, an expected average observation time of 70 seconds
Vascular complications in the surgery
including thrombosis, hematoma, and vasospasm
Measured: postoperative, within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start15 Jan 2023
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Lv, Qianfoshan Hospital
- Investigators
- Meng Lv, doctor, Principal investigator, Jinan, Shandong Province, China, 250000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687370
- Sponsor's protocol ID
- YXLL-KY-2022(104)
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05687370
- Acronym / sponsor ID
- YXLL-KY-2022(104)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 18 Jan 2023 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified dynamic needle tip positioning technique | Active comparator | Procedure: Modified dynamic needle tip positioning under ultrasound-guidanceIn 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. |
| Long-axis in-plane technique | Active comparator | Procedure: Long-axis technique |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
- Requires invasive arterial blood pressure monitoring;
- New York Heart Association(NYHA) classification I, II or III;
- The American Society of Anesthesiologists (ASA) classification I, II or III;
- Patients older than 18 years and younger than 85 years (Adult);
Key exclusion criteria (10 listed)
- Patients with hemodynamically unstable (systolic blood pressure 60 or less);
- Patients with abnormal results of the modified Allen test;
- Patients with ulnar artery occlusion;
- Patients with coagulation disorders;
- Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
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 |
|---|---|---|
| Modified dynamic needle tip positioning under ultrasound-guidanceThe tip of needle is positioned under ultrasound-guidance using modified dynamic short-axis view. | Procedure or surgery | Modified dynamic needle tip positioning technique |
| Long-axis techniqueThe tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view. | Procedure or surgery | Long-axis in-plane technique |
Primary outcome
Success rate of the radial artery cannulation at first attempt
Time frame: intraoperative
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
5 secondary outcomes
Time of arterial catheterization
Time frame: 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
Time to first puncture of the artery
Time frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds
Time ultrasound imaging
Time frame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds
Number of puncture attempts
Time frame: Up to 5 times, an expected average observation time of 70 seconds
Vascular complications in the surgery
Time frame: postoperative, within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
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.
Meng Lv, doctor principal investigator
Jinan, Shandong Province, China, 250000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified dynamic needle tip positioning under ultrasound-guidance and Long-axis technique in people with Ultrasound and Arterial Catheterization, run by Qianfoshan Hospital 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 30 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the radial artery cannulation at first attempt (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.