Radial Artery CatheterizationNCT03920423
Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach
A study testing improvement of arterial depth in people with Radial Artery Catheterization and Ultrasound or Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study is designed to evaluate and validate impact factors to success and complication using ultrasound guided short-axis out-of-plane dynamic approach, and validate the impaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Catheterization, Ultrasound or Ultrasonography, Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
- What is being tested?
- improvement of arterial depth
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 17 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requirement of radial arterial catheterization during perioperative period
- within cardiac-vascular disease
- written consent
Who cannot join
- contraindication to radial arterial catheterization
- abnormal artery evaluated by ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Factors to Success Without Posterior Wall Puncture Using Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
The study is designed to evaluate and validate impact factors to success and complication using ultrasound guided short-axis out-of-plane dynamic approach, and validate the impaction.
Read the detailed description
The study including two phase: observational phase and validation phase. In observational phase, factors relative to success catheterization without posterior puncture and success in first attempt are evaluated. In validation phase, patients are randomized into different depth group with or without injection of saline. Success without posterior wall puncture, success in first attempt and overall, catheterization time are compared between groups.
- Conditions
- Radial Artery Catheterization, Ultrasound or Ultrasonography, Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
- Being tested
- improvement of arterial depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improvement of arterial depthProcedure or surgery
deepen radial arterial depth by injection of saline to more than deep cutoff point relative to result.
| Study group | Role | What they receive |
|---|---|---|
| shallow depth | No intervention | Radial arterial deth is shallow than the cutoff point that relative to results. |
| improved depth | Experimental | Radial arterial deth is shallow than the cutoff point that relative to results, and increased by injection of saline to more than deep cutoff point. Receives: Procedure: improvement of arterial depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
success without posterior wall puncture
success to puncture and catheterize of radial artery, without posterior wall puncture.
Measured: Through study completion,an average of 5 minutes
success in first attempt
success puncture and catheterization in first attempt
Measured: Through study completion,an average of 5 minutes
Secondary outcomes (2)
success overall
success catheterization with the maximum of 10 minutes
Measured: Through study completion,an average of 5 minutes
time needed to catheterization
time required for successful puncturing and catheterization with the maximum of 10 minutes
Measured: Through study completion,an average of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start22 Apr 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CatheterizationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920423
- Sponsor's protocol ID
- 1338
- Status last verified
- Aug 2020
- First submitted
- 15 Apr 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Factors to Success Without Posterior Wall Puncture Using Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
- ClinicalTrials.gov ID
- NCT03920423
- Acronym / sponsor ID
- 1338
- Conditions
- Radial Artery Catheterization, Ultrasound or Ultrasonography, Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 18 Apr 2019 (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 study is designed to evaluate and validate impact factors to success and complication using ultrasound guided short-axis out-of-plane dynamic approach, and validate the impaction.
Detailed description
The study including two phase: observational phase and validation phase. In observational phase, factors relative to success catheterization without posterior puncture and success in first attempt are evaluated. In validation phase, patients are randomized into different depth group with or without injection of saline. Success without posterior wall puncture, success in first attempt and overall, catheterization time are compared between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shallow depth | No intervention | –Radial arterial deth is shallow than the cutoff point that relative to results. |
| improved depth | Experimental | Procedure: improvement of arterial depthRadial arterial deth is shallow than the cutoff point that relative to results, and increased by injection of saline to more than deep cutoff point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- requirement of radial arterial catheterization during perioperative period
- within cardiac-vascular disease
- written consent
Key exclusion criteria (2 listed)
- contraindication to radial arterial catheterization
- abnormal artery evaluated by ultrasonography
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 |
|---|---|---|
| improvement of arterial depthdeepen radial arterial depth by injection of saline to more than deep cutoff point relative to result. | Procedure or surgery | improved depth |
Primary outcome
success without posterior wall puncture
Time frame: Through study completion,an average of 5 minutes
success to puncture and catheterize of radial artery, without posterior wall puncture.
success in first attempt
Time frame: Through study completion,an average of 5 minutes
success puncture and catheterization in first attempt
2 secondary outcomes
success overall
Time frame: Through study completion,an average of 5 minutes
time needed to catheterization
Time frame: Through study completion,an average of 5 minutes
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 31 Aug 2020.
- 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.
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?
A study testing improvement of arterial depth in people with Radial Artery Catheterization and Ultrasound or Ultrasonography, run by Peking Union Medical College 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 3 inclusion and 2 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 31 Aug 2020. 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?
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?
success without posterior wall puncture (time frame: Through study completion,an average of 5 minutes). 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 31 Aug 2020.