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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Aarhus Universitets Hospital

    Aarhus, Jylland, 8200

Other trials in Denmark

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.

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 groups in NCT01690416
Study groupRoleWhat they receive
Ultrasound DNTPActive comparatorthe 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 techniqueActive comparatorarteria 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.

  1. Attempts

    The number of attempts (skin punctures) per catheterization

    Measured: 1 hour

  2. Withdrawals

    The number of withdrawals of the guide-needle per catheterization

    Measured: 1 hour

  3. Time consume

    The time spend for the catheterization procedure

    Measured: minutes

  4. Catheters

    The number of utilized catheters

    Measured: 1 hour

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted21 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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)
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

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.

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