Radial Artery CatheterizationNCT04806932
Comparison of the Modified and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in ICU Hypotensive Patients.
A study testing The modified approach and The conventional approach in people with Radial Artery Catheterization, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Radial artery cannulation can be performed under short-axis ultrasound guidance. However, the first puncture success rate was low in patients with hypotensive patients. Compared with the conventional approach, the modified approach combined the ultrasonic location system with a dynamic needle tip positioning… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radial Artery Catheterization
- What is being tested?
- The modified approach and The conventional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2021to 28 Feb 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in intensive care units;
- The need for invasive hemodynamic monitoring (arterial blood pressure and cardiac output monitoring);
- The need for frequent blood sampling (arterial blood gas analysis and general laboratory evaluation);
- Vasopressor therapy;
Who cannot join
- a negative Allen test;
- ulnar artery occlusion;
- prevalent atherosclerosis;
- a blocked or embolized target vessel determined by ultrasound assessment;
- Raynaud disease;
- infection near the radial artery puncture site;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Guowei Tu, PhD, +8613501996995, tu.guowei@zs-hospital.sh.cn
Zhe Luo, PhD, +8613916127028, luo.zhe@zs-hospital.sh.cn
About this study
Official title: Comparison of the Modified Approach and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in Intensive Care Unit(ICU) Hypotensive Patients: a Randomized Controlled Study.
Radial artery cannulation can be performed under short-axis ultrasound guidance. However, the first puncture success rate was low in patients with hypotensive patients. Compared with the conventional approach, the modified approach combined the ultrasonic location system with a dynamic needle tip positioning technique. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided radial artery cannulation in hypotensive ICU patients.
Read the detailed description
Hypotensive patients in the intensive care unit may have extremely unstable hemodynamics. Blood pressure is the most important outcome in the diagnosis and treatment of shock. Vasopressor drugs are often required to maintain blood pressure in addition to fluid infusion. Noninvasive blood pressure measurement is unable to meet the clinical requirements. It is necessary to establish an invasive blood pressure monitoring method as soon as possible that can observe the real-time pressure. Radial artery cannulation has become the most commonly used due to its superficial location and less severe complication. However, radial artery cannulation is difficult to achieve in hypotensive patients due to weak radial artery pulsation, small arterial diameter, and peripheral vasospasm as blood flow is directed toward central vessels.
Some studies have shown that ultrasound-guided cannulation is more successful than the palpation technique. However, the success rate is largely dependent on the ultrasound operator's experience and skills. The operator requires good hand-eye coordination, technical skills, and some experience to overcome this shortcoming of ultrasound, which limits the advantages of ultrasound-guided vascular puncture, especially for operators with insufficient experience. There are 2 basic approaches in needling techniques: short-axis out-of-plane(SA-OOP) and long-axis in-plane(LA-IP) techniques.
In-plane technology requires the operator to be very skilled at ultrasound technology, which is more dependent on experience and can be difficult for novices to master; on the other hand, given that the long axis is subject to slice-thickness artifacts, due to the measurable thickness of the ultrasound beam itself, the cannula in the long axis appears to be in the same plane as the extremely small radial artery, even when the cannula has not been successfully inserted into the artery. Therefore, we prefer the out-of-plane technique.
The short-axis view has the advantages of providing better visualization of the surrounding structures and easier imaging which is convenient for novices to master. The procedure of radial artery puncture can be divided into 3 steps. The first step is to locate the puncture site, the second step is the puncture, and the last step entails the insertion of the cannula into the radial artery.
The first step is particularly important because appropriate localization facilitates the success of the puncture and insertion. The first difficulty encountered during radial artery puncture is the exact positioning of the puncture point. Ultrasound with developing lines guided by dynamic ultrasound has achieved a good effect in patients without hypotension. In the group with the modified technique, we use the developing line to locate the puncture site.
The second difficulty encountered during radial artery puncture is the risk of posterior wall penetration. With the dynamic needle tip positioning(DNTP) technique, the operator keeps real-time track of the position of the needle tip at all times which significantly reduces the chance of posterior wall perforation. We combined the developing line and DNTP technique in the modified group and assume that the technique theoretically increases the success rate and decreases the complication rate of radial artery puncture. Therefore, in this trial, we compared the success rate of radial artery puncture using the traditional method and modified technique in hypotensive ICU patients.
- Conditions
- Radial Artery Catheterization
- Being tested
- The modified approach, The conventional approach
- Keywords
- radial artery catheterization, ultrasound, hypotensive, critical ill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The modified approachProcedure or surgery
The first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed.
The conventional approachProcedure or surgery
The conventional approach
| Study group | Role | What they receive |
|---|---|---|
| The modified approach | Active comparator | The first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed. Receives: Procedure: The modified approach |
| The conventional approach | Placebo comparator | The first three attempts via the conventional approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed. Receives: Procedure: The conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-pass success
successful catheterization on the first attempt
Measured: approximately 3 minutes
Secondary outcomes (5)
Overall success
successful catheterization without a limit on the number of punctures.
Measured: within 10 minutes
The cannulation time
the interval between skin contact with the probe and confirmation of the arterial waveform on the monitor.
Measured: within 10 minutes
Posterior wall puncture
the operator saw the needle passing the posterior wall or blood backflow appeared then disappeared while needle advancing.
Measured: within 10 minutes
the number of attempts
the number of attempts until successful cannulation
Measured: within 10 minutes
Complication rate
bleeding, hematoma,thrombosis, vasospasm, occlusion, aneurysm
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start11 Apr 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion28 Feb 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 Radial Artery CatheterizationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yangpu District Central Hospital Affiliated to Tongji University
- Responsible party
- Sponsor
- Investigators
- Guowei Tu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806932
- Sponsor's protocol ID
- MARS
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.
PubMed 24806143Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
PubMed 29787409Clemmesen L, Knudsen L, Sloth E, Bendtsen T. Dynamic needle tip positioning - ultrasound guidance for peripheral vascular access. A randomized, controlled and blinded study in phantoms performed by ultrasound novices. Ultraschall Med. 2012 Dec;33(7):E321-E325. doi: 10.1055/s-0032-1312824. Epub 2012 Oct 11.
PubMed 23059741
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Modified Approach and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in Intensive Care Unit(ICU) Hypotensive Patients: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04806932
- Acronym / sponsor ID
- MARS
- Conditions
- Radial Artery Catheterization
- Keywords
- radial artery catheterization, ultrasound, hypotensive, critical ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Yangpu District Central Hospital Affiliated to Tongji University
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 19 Mar 2021 (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.
Radial artery cannulation can be performed under short-axis ultrasound guidance. However, the first puncture success rate was low in patients with hypotensive patients. Compared with the conventional approach, the modified approach combined the ultrasonic location system with a dynamic needle tip positioning technique. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided radial artery cannulation in hypotensive ICU patients.
Detailed description
Hypotensive patients in the intensive care unit may have extremely unstable hemodynamics. Blood pressure is the most important outcome in the diagnosis and treatment of shock. Vasopressor drugs are often required to maintain blood pressure in addition to fluid infusion. Noninvasive blood pressure measurement is unable to meet the clinical requirements. It is necessary to establish an invasive blood pressure monitoring method as soon as possible that can observe the real-time pressure. Radial artery cannulation has become the most commonly used due to its superficial location and less severe complication. However, radial artery cannulation is difficult to achieve in hypotensive patients due to weak radial artery pulsation, small arterial diameter, and peripheral vasospasm as blood flow is directed toward central vessels.
Some studies have shown that ultrasound-guided cannulation is more successful than the palpation technique. However, the success rate is largely dependent on the ultrasound operator's experience and skills. The operator requires good hand-eye coordination, technical skills, and some experience to overcome this shortcoming of ultrasound, which limits the advantages of ultrasound-guided vascular puncture, especially for operators with insufficient experience. There are 2 basic approaches in needling techniques: short-axis out-of-plane(SA-OOP) and long-axis in-plane(LA-IP) techniques.
In-plane technology requires the operator to be very skilled at ultrasound technology, which is more dependent on experience and can be difficult for novices to master; on the other hand, given that the long axis is subject to slice-thickness artifacts, due to the measurable thickness of the ultrasound beam itself, the cannula in the long axis appears to be in the same plane as the extremely small radial artery, even when the cannula has not been successfully inserted into the artery. Therefore, we prefer the out-of-plane technique.
The short-axis view has the advantages of providing better visualization of the surrounding structures and easier imaging which is convenient for novices to master. The procedure of radial artery puncture can be divided into 3 steps. The first step is to locate the puncture site, the second step is the puncture, and the last step entails the insertion of the cannula into the radial artery.
The first step is particularly important because appropriate localization facilitates the success of the puncture and insertion. The first difficulty encountered during radial artery puncture is the exact positioning of the puncture point. Ultrasound with developing lines guided by dynamic ultrasound has achieved a good effect in patients without hypotension. In the group with the modified technique, we use the developing line to locate the puncture site.
The second difficulty encountered during radial artery puncture is the risk of posterior wall penetration. With the dynamic needle tip positioning(DNTP) technique, the operator keeps real-time track of the position of the needle tip at all times which significantly reduces the chance of posterior wall perforation. We combined the developing line and DNTP technique in the modified group and assume that the technique theoretically increases the success rate and decreases the complication rate of radial artery puncture. Therefore, in this trial, we compared the success rate of radial artery puncture using the traditional method and modified technique in hypotensive ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The modified approach | Active comparator | Procedure: The modified approachThe first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed. |
| The conventional approach | Placebo comparator | Procedure: The conventional approachThe first three attempts via the conventional approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in intensive care units;
- The need for invasive hemodynamic monitoring (arterial blood pressure and cardiac output monitoring);
- The need for frequent blood sampling (arterial blood gas analysis and general laboratory evaluation);
- Vasopressor therapy;
Key exclusion criteria (6 listed)
- a negative Allen test;
- ulnar artery occlusion;
- prevalent atherosclerosis;
- a blocked or embolized target vessel determined by ultrasound assessment;
- Raynaud disease;
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 |
|---|---|---|
| The modified approachThe first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed. | Procedure or surgery | The modified approach |
| The conventional approachThe conventional approach | Procedure or surgery | The conventional approach |
Primary outcome
First-pass success
Time frame: approximately 3 minutes
successful catheterization on the first attempt
5 secondary outcomes
Overall success
Time frame: within 10 minutes
The cannulation time
Time frame: within 10 minutes
Posterior wall puncture
Time frame: within 10 minutes
the number of attempts
Time frame: within 10 minutes
Complication rate
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 24806143Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.
- Background: PubMed 29787409Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
- Background: PubMed 23059741Clemmesen L, Knudsen L, Sloth E, Bendtsen T. Dynamic needle tip positioning - ultrasound guidance for peripheral vascular access. A randomized, controlled and blinded study in phantoms performed by ultrasound novices. Ultraschall Med. 2012 Dec;33(7):E321-E325. doi: 10.1055/s-0032-1312824. Epub 2012 Oct 11.
- Individual participant dataSharing planned: No
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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.
Guowei Tu, PhD principal investigator
Fudan 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 The modified approach and The conventional approach in people with Radial Artery Catheterization, run by Shanghai Zhongshan 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 4 inclusion and 6 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 May 2021. 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. Some participants in this study may receive a placebo. 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 Hongyu He, PhD (021-64041990 ext. 692958, he.hongyu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass success (time frame: approximately 3 minutes). 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 NCT04806932, 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 May 2021.