Disorder of Cardiac FunctionNCT01690416
Conventional vs Ultrasound Guided Arteria Cannulation.
A study testing Traditional palpation technique and Ultrasound DNTP in people with Disorder of Cardiac Function, run by Aarhus University Hospital Skejby 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 years
- Conditions the study is for
- Disorder of Cardiac Function
- What is being tested?
- Traditional palpation technique and Ultrasound DNTP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Feb 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 20 to 90 years
- All sexes
- No healthy volunteers
- 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 compromised flow in either the radial or ulnar artery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional vs Ultrasound Guided Arteria Cannulation
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.
It has been shown that inexperienced trainees lear the technique SAX-OOP and DNTT very quickly.
First investigators hypothesize that the number of attempts, the number of withdrawals, the time spend and the number of utilized catheters will be decreased using ultrasound vs. the traditional method. Secondly investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia. Thirdly 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. Fourthly investigators hypothesize that the use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure.
- Conditions
- Disorder of Cardiac Function
- Being tested
- Traditional palpation technique, Ultrasound DNTP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional palpation techniqueProcedure or surgery
Ultrasound DNTPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound DNTP | Active comparator | the catheter will be placed using ultrasound and DNTT and Lidocaine as local anesthesia, by the same fellow as the one who performs the puncture with the traditional method Receives: Procedure: Traditional palpation technique; Procedure: Ultrasound DNTP |
| Traditional palpation technique | Active comparator | arteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow Receives: Procedure: Traditional palpation technique; Procedure: Ultrasound DNTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attempts
The number of attempts (skin punctures) per catheterization
Measured: 1 hour
Withdrawals
The number of withdrawals of the guide-needle per catheterization
Measured: 1 hour
Time consume
The time spend for the catheterization procedure
Measured: minutes
Catheters
The number of utilized catheters
Measured: 1 hour
Secondary outcomes (2)
pain
The pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia measured on a VAS-score.
Measured: momentan
Ease of method for the operator
The use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure on a Likert scale.
Measured: momentan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Cardiac FunctionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene A Hansen, Stud.med, Aarhus University Hospital Skejby
- Investigators
- Marlene Aa Hansen, stud.med, Principal investigator, Anæstesiologisk-Intensiv afd I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690416
- Sponsor's protocol ID
- sloth2
- Other IDs
- Overlæge Dr. Med Edgar Schnohr
- Status last verified
- May 2015
- First submitted
- 13 Sep 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional vs Ultrasound Guided Arteria Cannulation
- ClinicalTrials.gov ID
- NCT01690416
- Acronym / sponsor ID
- sloth2
- Conditions
- Disorder of Cardiac Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Sep 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.
It has been shown that inexperienced trainees lear the technique SAX-OOP and DNTT very quickly.
First investigators hypothesize that the number of attempts, the number of withdrawals, the time spend and the number of utilized catheters will be decreased using ultrasound vs. the traditional method. Secondly investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia. Thirdly 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. Fourthly investigators hypothesize that the use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound DNTP | Active comparator | Procedure: Traditional palpation technique, Procedure: Ultrasound DNTPthe catheter will be placed using ultrasound and DNTT and Lidocaine as local anesthesia, by the same fellow as the one who performs the puncture with the traditional method |
| Traditional palpation technique | Active comparator | Procedure: Traditional palpation technique, Procedure: Ultrasound DNTParteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not 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 compromised flow in either the radial or ulnar artery.
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 |
|---|---|---|
| Traditional palpation technique | Procedure or surgery | Traditional palpation technique, Ultrasound DNTP |
| Ultrasound DNTP | Procedure or surgery | Traditional palpation technique, Ultrasound DNTP |
Primary outcome
Attempts
Time frame: 1 hour
The number of attempts (skin punctures) per catheterization
Withdrawals
Time frame: 1 hour
The number of withdrawals of the guide-needle per catheterization
Time consume
Time frame: minutes
The time spend for the catheterization procedure
Catheters
Time frame: 1 hour
The number of utilized catheters
2 secondary outcomes
pain
Time frame: momentan
Ease of method for the operator
Time frame: momentan
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 12 May 2015.
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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
Anæstesiologisk-Intensiv afd I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional palpation technique and Ultrasound DNTP in people with Disorder of Cardiac Function, run by Aarhus University Hospital Skejby 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 12 May 2015. 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?
Attempts (time frame: 1 hour). The study lists 4 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 12 May 2015.