Radial Artery CannulationNCT05920538
Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation
A study testing Nicardipine and Normal saline in people with Radial Artery Cannulation, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radial Artery Cannulation
- What is being tested?
- Nicardipine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteThailand
- Study dates
- 13 Mar 2023to Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years
- the patient who need to arterial line
Who cannot join
- allergy to nicardipine
- history of peripheral artery disease
- BMI > 40 kg/m2
- unwilling to participate or denial of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation
- Conditions
- Radial Artery Cannulation
- Being tested
- Nicardipine, Normal saline
- Keywords
- Nicardipine, radial artery, artery cannulation, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Subcutaneous infiltrate drug at puncture site by ultrasound-guided
Normal salineOther
Subcutaneous infiltrate NSS at puncture site by ultrasound-guided
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine | Experimental | Using nicardipine 0.5 mg(0.5ml) subcutaneously infiltrated by ultrasound before redial artery cannulation. Receives: Drug: Nicardipine |
| Normal saline | Placebo comparator | Using normal saline 0.5ml subcutaneously infiltrated by ultrasound before redial artery cannulation Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of radial artery cannulation since first skin puncture
Success rate of radial artery cannulation since first skin puncture
Measured: 10 minute from puncture at skin
Secondary outcomes (2)
radial artery diameter
Pre-induction radial artery diameter, post-induction radial artery diameter, radial artery diameter after subcutaneous infiltration at 0,1,2 and 3 minute
Measured: Pre-induction to 3 minute after subcutaneous infiltration
Time from first skin puncture to success cannulation
Time from first skin puncture to present of arterial wave form, assessed less than 10 minutes
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start13 Mar 2023
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CannulationStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuriphon Songarj, MD, Study director, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920538
- Sponsor's protocol ID
- 764/2565(IRB3)
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation
- ClinicalTrials.gov ID
- NCT05920538
- Acronym / sponsor ID
- 764/2565(IRB3)
- Conditions
- Radial Artery Cannulation
- Keywords
- Nicardipine, radial artery, artery cannulation, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 27 Jun 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.
The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicardipine | Experimental | Drug: NicardipineUsing nicardipine 0.5 mg(0.5ml) subcutaneously infiltrated by ultrasound before redial artery cannulation. |
| Normal saline | Placebo comparator | Other: Normal salineUsing normal saline 0.5ml subcutaneously infiltrated by ultrasound before redial artery cannulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-75 years
- the patient who need to arterial line
Key exclusion criteria (4 listed)
- allergy to nicardipine
- history of peripheral artery disease
- BMI > 40 kg/m2
- unwilling to participate or denial of informed consent
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 |
|---|---|---|
| NicardipineSubcutaneous infiltrate drug at puncture site by ultrasound-guided | Drug | Nicardipine |
| Normal salineSubcutaneous infiltrate NSS at puncture site by ultrasound-guided | Other | Normal saline |
Primary outcome
Success rate of radial artery cannulation since first skin puncture
Time frame: 10 minute from puncture at skin
Success rate of radial artery cannulation since first skin puncture
2 secondary outcomes
radial artery diameter
Time frame: Pre-induction to 3 minute after subcutaneous infiltration
Time from first skin puncture to success cannulation
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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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.
Phuriphon Songarj, MD study director
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and Normal saline in people with Radial Artery Cannulation, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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 27 Jun 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 Thailand. 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?
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 radial artery cannulation since first skin puncture (time frame: 10 minute from puncture at skin). 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 27 Jun 2023.