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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Conventional Line-blocking, Bar-blocking and V-blocking
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.

China1 site
  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 423400

Other trials in China

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 groups in NCT05735132
Study groupRoleWhat they receive
Line armActive comparatorConventional line blocking is used in radial artery cannulation for local infiltration.
Receives: Procedure: Conventional Line-blocking
Bar armExperimentalBar-blocking is used in radial artery cannulation for local infiltration.
Receives: Procedure: Bar-blocking
V armExperimentalV-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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. Heart rate

    Heart rate changes will be recorded to supplementally evaluate the pain intensity during the cannulation.

    Measured: upto 5 minutes

  4. 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.

  1. First posted21 Feb 2023
  2. Study start5 Feb 2023
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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)
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

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.

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