Heart DiseasePhase 3NCT01561196
Conventional Verses Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
A Phase 3 study testing arterial catheterisation in people with Heart Disease, run by Marlene A Hansen, Stud.med at 1 site in Denmark.
Trial summary
The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- arterial catheterisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-90 years
- Fulfill the criteria of an operation
- Routine need of an arterial needle
Who cannot join
- Lack of patient consent
- Ultrasound identified plaques in the radial artery or ultrasound verified positive Allens test or traditional positive Allens test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.
Read the detailed description
The practice of placing vascular catheters is used many times every day at almost every hospital. It is a safe procedure which generally does not imply problems. Though the procedural optimum aren't reached. The procedure still fails some times and induce complications. When the catheter is placed using the traditional method the pulse is palpated by the operator's fingers. This is only to be done near the hand wrist. In this position the catheter steadiness is fragile but because the pulse can't be sensed more proximal the operator is forced to choose this position. This it though a problem that can be solved by non invasive visualization technology. Ultrasound-guidance for central vascular access is already well-established. However, in recent years ultrasound-guidance for peripheral vascular access has gained popularity too. The evidence of multiple studies demonstrates increased success rate and reduced complication rate with ultrasound compared to blind landmark technique for vascular catheter placement.
In recent years there have been both procedural technique and technology improvements in the field of ultrasound. This has led to the improvement of procedural catheterisation techniques that now can be done by novices with higher attempt success rate than traditional method. One technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a more proximal direction on the forearm and the investigators believe that by the help of the exposed procedure on the monitor many complications can be reduced.
Hypothesis; Firstly the investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT without local anesthesia. Secondly the investigators hypothesize that the use of DNTT for the placement of the arterial catheter will decrease the time spend, amount of complications (hematoma), the number of pricks, the number of utilized catheters compared to the traditional palpation method. Thirdly the investigators claim that the best anatomical place to put the catheter isn't always corresponding with the spot chosen by palpation, which increase the number of failures.
- Conditions
- Heart Disease
- Being tested
- arterial catheterisation
- Keywords
- arteria cannulation, Ultrasound, pain, complications
- Medical subject headings
- Heart Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial catheterisationProcedure or surgery
Also called ICD10 I95.9
arterial catheterisation in Arterial Radialis
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided arterial cannulation | Active comparator | The arterial needle is placed using ultrasound monitoring for guiding the operator. Receives: Procedure: arterial catheterisation |
| Conventional cannulation | Active comparator | the arterial needle is placed using the traditional method and lidocaine. The operator decides where to place the needle in the forearm Receives: Procedure: arterial catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on visual analog scale
The primary outcome is the subjective feeling of pain following the two methods.
Measured: 5 minutes
Secondary outcomes (4)
Time spend on the procedure
Time will be measured from the point where 1) the operator starts searching for the patients plus or 2) the operator starts examining the patient with the ultrasound machine. The time will be stopped at the time where the catheter is successfully placed.
Measured: 1 day
Number of utilized needles
Measured: 1 day
number of pricks
a prick is defined as eruption of the skin
Measured: 1 day
number of withdrawals
a withdrawal is defined as backwards movement of the needle or the needle+catheter.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marlene A Hansen, Stud.med
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marlene A Hansen, Stud.med, Aarhus University Hospital Skejby
- Investigators
- Marlene Aa Hansen, stud.med, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561196
- Sponsor's protocol ID
- Sloth1
- Status last verified
- Jan 2013
- First submitted
- 13 Mar 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
- ClinicalTrials.gov ID
- NCT01561196
- Acronym / sponsor ID
- Sloth1
- Conditions
- Heart Disease
- Keywords
- arteria cannulation, Ultrasound, pain, complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marlene A Hansen, Stud.medUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Mar 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 aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.
Detailed description
The practice of placing vascular catheters is used many times every day at almost every hospital. It is a safe procedure which generally does not imply problems. Though the procedural optimum aren't reached. The procedure still fails some times and induce complications. When the catheter is placed using the traditional method the pulse is palpated by the operator's fingers. This is only to be done near the hand wrist. In this position the catheter steadiness is fragile but because the pulse can't be sensed more proximal the operator is forced to choose this position. This it though a problem that can be solved by non invasive visualization technology. Ultrasound-guidance for central vascular access is already well-established. However, in recent years ultrasound-guidance for peripheral vascular access has gained popularity too. The evidence of multiple studies demonstrates increased success rate and reduced complication rate with ultrasound compared to blind landmark technique for vascular catheter placement.
In recent years there have been both procedural technique and technology improvements in the field of ultrasound. This has led to the improvement of procedural catheterisation techniques that now can be done by novices with higher attempt success rate than traditional method. One technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a more proximal direction on the forearm and the investigators believe that by the help of the exposed procedure on the monitor many complications can be reduced.
Hypothesis; Firstly the investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT without local anesthesia. Secondly the investigators hypothesize that the use of DNTT for the placement of the arterial catheter will decrease the time spend, amount of complications (hematoma), the number of pricks, the number of utilized catheters compared to the traditional palpation method. Thirdly the investigators claim that the best anatomical place to put the catheter isn't always corresponding with the spot chosen by palpation, which increase the number of failures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided arterial cannulation | Active comparator | Procedure: arterial catheterisationThe arterial needle is placed using ultrasound monitoring for guiding the operator. |
| Conventional cannulation | Active comparator | Procedure: arterial catheterisationthe arterial needle is placed using the traditional method and lidocaine. The operator decides where to place the needle in the forearm |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-90 years
- Fulfill the criteria of an operation
- Routine need of an arterial needle
Key exclusion criteria (2 listed)
- Lack of patient consent
- Ultrasound identified plaques in the radial artery or ultrasound verified positive Allens test or traditional positive Allens test
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 |
|---|---|---|
| arterial catheterisationAlso: ICD10 I95.9arterial catheterisation in Arterial Radialis | Procedure or surgery | Conventional cannulation, Ultrasound guided arterial cannulation |
Primary outcome
Pain score on visual analog scale
Time frame: 5 minutes
The primary outcome is the subjective feeling of pain following the two methods.
4 secondary outcomes
Time spend on the procedure
Time frame: 1 day
Number of utilized needles
Time frame: 1 day
number of pricks
Time frame: 1 day
number of withdrawals
Time frame: 1 day
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 Jan 2013.
- Aarhus university Hospital, SkejbyLink provided by the sponsor.
- The danish local ethical komitéLink provided by the sponsor.
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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.
Marlene Aa Hansen, stud.med principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing arterial catheterisation in people with Heart Disease, run by Marlene A Hansen, Stud.med 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 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 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score on visual analog scale (time frame: 5 minutes). 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 Jan 2013.