Efficiency and Safey of Radial Artery CannulationNCT05735132
Novel Local Infiltration Anesthesia for Radial Artery Cannulation.
A study testing Conventional Line-blocking, Bar-blocking and V-blocking in people with Efficiency and Safey of Radial Artery Cannulation, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
This clinical trial aims to compare the pain scores and cannulation success rates of conventional, bar-shaped, and V-shaped local infiltration anesthesia in participants' radial artery cannulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Efficiency and Safey of Radial Artery Cannulation
- What is being tested?
- Conventional Line-blocking, Bar-blocking and V-blocking
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2023to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is scheduled for elective surgery.
- The participant's elective surgery required radial artery cannulation.
- Participants should be at least 18 years old.
Who cannot join
- The Allen test of the participant is negative.
- The participant has a history of peripheral vascular disease.
- The participant has a cannula site infection or lesion.
- The participant is on vasoactive medication.
- A history of artery cannulation at the planned cannulation site within the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Effects of Conventional, Bar-shaped, and V-shaped Local Infiltration Anesthesia on Pain Relief and Cannulation Success Rate in Patients Requiring Radial Artery Cannulation.
This clinical trial aims to compare the pain scores and cannulation success rates of conventional, bar-shaped, and V-shaped local infiltration anesthesia in participants' radial artery cannulation.
The main questions it aims to answer are:
Read more
- Are bar-shaped and V-shaped more successful than the conventional block in radial artery cannulation?
- Are bar-shaped and V-shaped less painful than the conventional block in radial artery cannulation? Participants will describe their pain score during their radial artery cannulation.
Researchers will compare the pain scores and cannulation success rates in bar-shaped, V-shaped, and conventional line blocking to see if bar-shaped and V-shaped blocking is better choices than conventional line blocking.
Read the detailed description
The purpose of the study, as well as the necessity, benefits, and risks of arterial cannulation, and the purpose of the study, were explained in detail to all participants screened by inclusion and exclusion criteria, and signed informed consent was obtained on the day before the operation.
Upon entering the operating room, participants will be connected to a pulse oximeter, noninvasive blood pressure monitor, and electrocardiograph and will record baseline heart rate, blood pressure, depth of the radial artery at the first wrist stripe before local anesthesia, and PVDF capacitance difference.
The arterial pressure transducer and tubing will be flushed with 25 U/mL of heparin saline and kept in a ready state.
Anesthesiologists not participating in the study will then be asked to open an opaque sealed envelope to determine the type of local anesthesia to be used during intubation. The conventional approach is to complete a 2 cm subcutaneous injection with 2% lidocaine directly above the artery in the direction of the palpable beat; the bar-blocking is to complete a 2 cm subcutaneous injection perpendicular to the arterial beat line 2 cm from the proximal segment of the puncture site, and the V-blocking is to complete a subcutaneous injection at a 90-degree angle with a 2-cm margin toward the distal end at 2 cm proximal to the puncture site. Heart rate, blood pressure, depth of the radial artery at the first wrist stripe, and PVDF capacitance difference were recorded at the end of local anesthesia.
The radial artery cannula will be placed with a 20 gauge radial artery catheter by palpation under the supervision of an anesthesia consultant in the operating room by another anesthesiology resident not involved in the study.
The participator's arm will be slightly abducted (less than 90 degrees) and placed on the arm board, placing the wrist in the extended position by placing a padded towel under the wrist. The wrist will then be secured to the arm board with tape. To maintain sterility, the wrist will be pretreated with 10% povidone-iodine, and surgical gloves and a sterile cloth will be used. The timer will start counting when the operator starts palpating the radial artery pulse. Immediately after successful cannulation, the assistant will connect a pressure monitoring tube. The timer will stop as soon as the arterial waveform appears on the monitor. The number of cannulations is also recorded, with one cannulation recorded for each skin puncture or each change of the puncture needle direction. If cannulation fails three times or if the radial artery is not cannulated after 360 seconds, the procedure will be aborted and recorded as "failed cannulation". A senior anesthesiologist will then complete the arterial cannulation using whatever method he/she decides. The time taken for cannulation is recorded, as well as the application of ultrasonography to measure the depth of the puncture site at the first wrist stripe after local anesthesia and the difference in PVDF membrane capacitance.
Systolic and diastolic blood pressures and heart rates were collected at the start and end of cannulation in the other arm, the time to successful placement of the radial artery cannula (in seconds), and the times of cannulation.
- Being tested
- Conventional Line-blocking, Bar-blocking, V-blocking
- Keywords
- Radial Artery, Local Anesthesia, Cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Line-blockingProcedure or surgery
Also called lidocaine infiltration at the point
Participants will receive a 2 cm subcutaneous 1% lidocaine local infiltration injection parallel to the arm at the puncture site.
Bar-blockingProcedure or surgery
Also called lidocaine infiltration with a cross bar
Participants will receive a bar-shaped subcutaneous 1% lidocaine local infiltration injection in the vertical arm, 2 cm away from the puncture site.
V-blockingProcedure or surgery
Also called lidocaine infiltration with v shape
Participants will receive a V-shaped subcutaneous 1% lidocaine local infiltration injection at a 90-degree angle 2 cm away from the puncture site.
| Study group | Role | What they receive |
|---|---|---|
| Line arm | Active comparator | Conventional line blocking is used in radial artery cannulation for local infiltration. Receives: Procedure: Conventional Line-blocking |
| Bar arm | Experimental | Bar-blocking is used in radial artery cannulation for local infiltration. Receives: Procedure: Bar-blocking |
| V arm | Experimental | V-blocking is used in radial artery cannulation for local infiltration. Receives: Procedure: V-blocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
The visual analogue scale (VAS) will evaluate pain intensity during radial artery cannulation. This scale is a 10-cm horizontal line with terminal descriptors of 0 (no pain) and 10 (worst imaginable pain) .
Measured: upto 10 minutes
Time spent on radial artery cannulation
From the completion of local infiltration anesthesia to the completion of radial artery cannulation, up to 15 minutes.
Measured: upto 5 minutes
Success rate of radial artery cannulation
Success rate will be recorded to evaluate the influences of local anesthesia to radial artery cannulation.
Measured: upto 3 months
Secondary outcomes (4)
Depth of tested radial artery
Depth of tested radial artery will be recorded to evaluate the influences of local anesthesia to radial artery cannulation.
Measured: upto 5 minutes
Polyvinylidene fluoride (PVDF) capacitance difference
PVDF capacitance difference will be recorded to evaluate the influences of local anesthesia to radial artery cannulation.
Measured: upto 5 minutes
Heart rate
Heart rate changes will be recorded to supplementally evaluate the pain intensity during the cannulation.
Measured: upto 5 minutes
Blood Pressure
Blood Pressure changes will be recorded to supplementally evaluate the pain intensity during the cannulation.
Measured: upto 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start5 Feb 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficiency and Safey of Radial Artery CannulationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, First People's Hospital of Chenzhou
- Investigators
- Bin Zeng, Master, Study chair, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735132
- Sponsor's protocol ID
- 2018012
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effects of Conventional, Bar-shaped, and V-shaped Local Infiltration Anesthesia on Pain Relief and Cannulation Success Rate in Patients Requiring Radial Artery Cannulation.
- ClinicalTrials.gov ID
- NCT05735132
- Acronym / sponsor ID
- 2018012
- Keywords
- Radial Artery, Local Anesthesia, Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Feb 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.
This clinical trial aims to compare the pain scores and cannulation success rates of conventional, bar-shaped, and V-shaped local infiltration anesthesia in participants' radial artery cannulation.
The main questions it aims to answer are:
- Are bar-shaped and V-shaped more successful than the conventional block in radial artery cannulation?
- Are bar-shaped and V-shaped less painful than the conventional block in radial artery cannulation? Participants will describe their pain score during their radial artery cannulation.
Researchers will compare the pain scores and cannulation success rates in bar-shaped, V-shaped, and conventional line blocking to see if bar-shaped and V-shaped blocking is better choices than conventional line blocking.
Detailed description
The purpose of the study, as well as the necessity, benefits, and risks of arterial cannulation, and the purpose of the study, were explained in detail to all participants screened by inclusion and exclusion criteria, and signed informed consent was obtained on the day before the operation.
Upon entering the operating room, participants will be connected to a pulse oximeter, noninvasive blood pressure monitor, and electrocardiograph and will record baseline heart rate, blood pressure, depth of the radial artery at the first wrist stripe before local anesthesia, and PVDF capacitance difference.
The arterial pressure transducer and tubing will be flushed with 25 U/mL of heparin saline and kept in a ready state.
Anesthesiologists not participating in the study will then be asked to open an opaque sealed envelope to determine the type of local anesthesia to be used during intubation. The conventional approach is to complete a 2 cm subcutaneous injection with 2% lidocaine directly above the artery in the direction of the palpable beat; the bar-blocking is to complete a 2 cm subcutaneous injection perpendicular to the arterial beat line 2 cm from the proximal segment of the puncture site, and the V-blocking is to complete a subcutaneous injection at a 90-degree angle with a 2-cm margin toward the distal end at 2 cm proximal to the puncture site. Heart rate, blood pressure, depth of the radial artery at the first wrist stripe, and PVDF capacitance difference were recorded at the end of local anesthesia.
The radial artery cannula will be placed with a 20 gauge radial artery catheter by palpation under the supervision of an anesthesia consultant in the operating room by another anesthesiology resident not involved in the study.
The participator's arm will be slightly abducted (less than 90 degrees) and placed on the arm board, placing the wrist in the extended position by placing a padded towel under the wrist. The wrist will then be secured to the arm board with tape. To maintain sterility, the wrist will be pretreated with 10% povidone-iodine, and surgical gloves and a sterile cloth will be used. The timer will start counting when the operator starts palpating the radial artery pulse. Immediately after successful cannulation, the assistant will connect a pressure monitoring tube. The timer will stop as soon as the arterial waveform appears on the monitor. The number of cannulations is also recorded, with one cannulation recorded for each skin puncture or each change of the puncture needle direction. If cannulation fails three times or if the radial artery is not cannulated after 360 seconds, the procedure will be aborted and recorded as "failed cannulation". A senior anesthesiologist will then complete the arterial cannulation using whatever method he/she decides. The time taken for cannulation is recorded, as well as the application of ultrasonography to measure the depth of the puncture site at the first wrist stripe after local anesthesia and the difference in PVDF membrane capacitance.
Systolic and diastolic blood pressures and heart rates were collected at the start and end of cannulation in the other arm, the time to successful placement of the radial artery cannula (in seconds), and the times of cannulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Line arm | Active comparator | Procedure: Conventional Line-blockingConventional line blocking is used in radial artery cannulation for local infiltration. |
| Bar arm | Experimental | Procedure: Bar-blockingBar-blocking is used in radial artery cannulation for local infiltration. |
| V arm | Experimental | Procedure: V-blockingV-blocking is used in radial artery cannulation for local infiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participant is scheduled for elective surgery.
- The participant's elective surgery required radial artery cannulation.
- Participants should be at least 18 years old.
Key exclusion criteria (5 listed)
- The Allen test of the participant is negative.
- The participant has a history of peripheral vascular disease.
- The participant has a cannula site infection or lesion.
- The participant is on vasoactive medication.
- A history of artery cannulation at the planned cannulation site within the past month.
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 |
|---|---|---|
| Conventional Line-blockingAlso: lidocaine infiltration at the pointParticipants will receive a 2 cm subcutaneous 1% lidocaine local infiltration injection parallel to the arm at the puncture site. | Procedure or surgery | Line arm |
| Bar-blockingAlso: lidocaine infiltration with a cross barParticipants will receive a bar-shaped subcutaneous 1% lidocaine local infiltration injection in the vertical arm, 2 cm away from the puncture site. | Procedure or surgery | Bar arm |
| V-blockingAlso: lidocaine infiltration with v shapeParticipants will receive a V-shaped subcutaneous 1% lidocaine local infiltration injection at a 90-degree angle 2 cm away from the puncture site. | Procedure or surgery | V arm |
Primary outcome
VAS score
Time frame: upto 10 minutes
The visual analogue scale (VAS) will evaluate pain intensity during radial artery cannulation. This scale is a 10-cm horizontal line with terminal descriptors of 0 (no pain) and 10 (worst imaginable pain) .
Time spent on radial artery cannulation
Time frame: upto 5 minutes
From the completion of local infiltration anesthesia to the completion of radial artery cannulation, up to 15 minutes.
Success rate of radial artery cannulation
Time frame: upto 3 months
Success rate will be recorded to evaluate the influences of local anesthesia to radial artery cannulation.
4 secondary outcomes
Depth of tested radial artery
Time frame: upto 5 minutes
Polyvinylidene fluoride (PVDF) capacitance difference
Time frame: upto 5 minutes
Heart rate
Time frame: upto 5 minutes
Blood Pressure
Time frame: upto 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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.
Bin Zeng, Master study chair
First People's Hospital of Chenzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Line-blocking, Bar-blocking and V-blocking in people with Efficiency and Safey of Radial Artery Cannulation, run by First People's Hospital of Chenzhou 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 3 inclusion and 5 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 21 Feb 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?
Results are not available in the source record.
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?
VAS score (time frame: upto 10 minutes). The study lists 3 primary outcomes in all. 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 21 Feb 2023.