Radial Artery, Regional Blood FlowNCT01089972
Ultrasonographic Evaluation of the Radial and Ulnar Blood Flow After Radial Arterial Cannulation
An observational study of Radial Artery, Regional Blood Flow, run by Severance Hospital at 1 site in South Korea.
Trial summary
The aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radial Artery, Regional Blood Flow
- What is being tested?
- 22 gauge catheter and 20 gauge catheter
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Sep 2010
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient(age >20) who are scheduled for elective surgery and need arterial
Who may be able to join
- The patient who are scheduled for elective surgery and need arterial cannulation
Who cannot join
- Coronary occlusive disease
- Known or suspected upper extremity peripheral arterial disease
- Coagulopathy
- DM with peripheral neuropathy
- Infection at puncture site
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation.
- Conditions
- Radial Artery, Regional Blood Flow
- Being tested
- 22 gauge catheter, 20 gauge catheter
- Keywords
- radial artery, ulnar artery, catheterization, regional blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22 gauge catheterDevice
radial artery cannulation using 22 gauge catheter
20 gauge catheterDevice
radial artery cannulation using 20 gauge catheter
| Study group | Role | What they receive |
|---|---|---|
| 20 gauge group | Not described Receives: Device: 20 gauge catheter | |
| 22 gauge group | Not described Receives: Device: 22 gauge catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery diameter and blood flow before and after cannulation
Measured: 30 min
Ulnar artery diameter and blood flow before and after cannulation
Measured: 30 min
Secondary outcomes (2)
The differences of radial artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
Measured: 30 min
The differences of ulnar artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery, Regional Blood FlowStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089972
- Sponsor's protocol ID
- IRB 1-2009-0033
- Status last verified
- Mar 2010
- First submitted
- 18 Mar 2010
- Last updated
- 1 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Radial and Ulnar Blood Flow After Radial Arterial Cannulation
- ClinicalTrials.gov ID
- NCT01089972
- Acronym / sponsor ID
- IRB 1-2009-0033
- Conditions
- Radial Artery, Regional Blood Flow
- Keywords
- radial artery, ulnar artery, catheterization, regional blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Mar 2010 (estimated)
- 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 aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 gauge group | – | Device: 20 gauge catheter |
| 22 gauge group | – | Device: 22 gauge catheter |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient(age >20) who are scheduled for elective surgery and need arterial
Key inclusion criteria (1 listed)
- The patient who are scheduled for elective surgery and need arterial cannulation
Key exclusion criteria (5 listed)
- Coronary occlusive disease
- Known or suspected upper extremity peripheral arterial disease
- Coagulopathy
- DM with peripheral neuropathy
- Infection at puncture 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 |
|---|---|---|
| 22 gauge catheterradial artery cannulation using 22 gauge catheter | Device | 22 gauge group |
| 20 gauge catheterradial artery cannulation using 20 gauge catheter | Device | 20 gauge group |
Primary outcome
Radial artery diameter and blood flow before and after cannulation
Time frame: 30 min
Ulnar artery diameter and blood flow before and after cannulation
Time frame: 30 min
2 secondary outcomes
The differences of radial artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
Time frame: 30 min
The differences of ulnar artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G)
Time frame: 30 min
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 1 Apr 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery, Regional Blood Flow, run by Severance Hospital at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 1 Apr 2011. 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 South Korea. 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?
Radial artery diameter and blood flow before and after cannulation (time frame: 30 min). The study lists 2 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 1 Apr 2011.