Arterial PunctureNCT01660724
Ultrasound Guided Arterial Puncture
A study testing Ultrasound guided arterial puncture and Conventional arterial puncture technique in people with Arterial Puncture, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Arterial Puncture
- What is being tested?
- Ultrasound guided arterial puncture and Conventional arterial puncture technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Aug 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient admitted or treated in the acute emergency department
- Indication for a arterial blood gas analysis, according to the physician responsible for the patient's hospital stay / treatment
Who cannot join
- Patient age < 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.
The main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is compared to conventional arterial puncture technique.
- Conditions
- Arterial Puncture
- Being tested
- Ultrasound guided arterial puncture, Conventional arterial puncture technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided arterial punctureProcedure or surgery
Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
Conventional arterial puncture techniqueProcedure or surgery
Arterial puncture is performed using the conventional technique
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided arterial puncture | Experimental | Patients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery Receives: Procedure: Ultrasound guided arterial puncture |
| Conventional arterial puncture technique | Active comparator | Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique Receives: Procedure: Conventional arterial puncture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis
Measured: up to 1 hour after arterial puncture
Secondary outcomes (4)
Time used for arterial puncture
Measured: up to 1 hour after arterial puncture
Patient corporation
Patient corporation is subjectively estimated by the physician performing the arterial puncture. The degree of patient corporation are assessed on a scale from 1 - 5, where 1 is very poor patient corporation and 5 is perfect patient corporation.
Measured: up to 1 hour after arterial puncture
Pain Scores on the Visual Analog Scale
Measured: Up to 1 hour after arterial puncture
Number of attempts before successfully acquiring arterial puncture
Measured: up to 1 hour after arterial puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial PunctureStudies of the same condition, open and under way.
- More trials run by Odense University 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Borbjerg Laursen, Odense University Hospital
- Investigators
- Christian B Laursen, MD, Principal investigator, Odense Universityhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660724
- Sponsor's protocol ID
- Mulvarp2012
- Status last verified
- Aug 2013
- First submitted
- 16 Jul 2012
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01660724
- Acronym / sponsor ID
- Mulvarp2012
- Conditions
- Arterial Puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Aug 2012 (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 main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is compared to conventional arterial puncture technique.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided arterial puncture | Experimental | Procedure: Ultrasound guided arterial puncturePatients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery |
| Conventional arterial puncture technique | Active comparator | Procedure: Conventional arterial puncture techniquePatients randomised to the active comparator arm has arterial puncture performed using the conventional technique |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient admitted or treated in the acute emergency department
- Indication for a arterial blood gas analysis, according to the physician responsible for the patient's hospital stay / treatment
Key exclusion criteria (1 listed)
- Patient age < 16 years
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 |
|---|---|---|
| Ultrasound guided arterial punctureArterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery | Procedure or surgery | Ultrasound guided arterial puncture |
| Conventional arterial puncture techniqueArterial puncture is performed using the conventional technique | Procedure or surgery | Conventional arterial puncture technique |
Primary outcome
The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis
Time frame: up to 1 hour after arterial puncture
4 secondary outcomes
Time used for arterial puncture
Time frame: up to 1 hour after arterial puncture
Patient corporation
Time frame: up to 1 hour after arterial puncture
Pain Scores on the Visual Analog Scale
Time frame: Up to 1 hour after arterial puncture
Number of attempts before successfully acquiring arterial puncture
Time frame: up to 1 hour after arterial puncture
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 5 Aug 2013.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
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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.
Christian B Laursen, MD principal investigator
Odense Universityhospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided arterial puncture and Conventional arterial puncture technique in people with Arterial Puncture, run by Odense University Hospital at 1 site in Denmark.
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 1 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 5 Aug 2013. 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 Denmark. 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?
The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis (time frame: up to 1 hour after arterial puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660724, which also lists 1 linked publication.
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 5 Aug 2013.