Conventional Verses Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561196
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Marlene A Hansen,, Aarhus University Hospital Skejby

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Disease Procedure: arterial catheterisation Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ultrasound guided arterial cannulation
The arterial needle is placed using ultrasound monitoring for guiding the operator.
Procedure: arterial catheterisation
arterial catheterisation in Arterial Radialis
Other Name: ICD10 I95.9

Active Comparator: Conventional cannulation
the arterial needle is placed using the traditional method and lidocaine. The operator decides where to place the needle in the forearm
Procedure: arterial catheterisation
arterial catheterisation in Arterial Radialis
Other Name: ICD10 I95.9

Primary Outcome Measures :
  1. Pain score on visual analog scale [ Time Frame: 5 minutes ]
    The primary outcome is the subjective feeling of pain following the two methods.

Secondary Outcome Measures :
  1. Time spend on the procedure [ Time Frame: 1 day ]
    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.

  2. Number of utilized needles [ Time Frame: 1 day ]
  3. number of pricks [ Time Frame: 1 day ]
    a prick is defined as eruption of the skin

  4. number of withdrawals [ Time Frame: 1 day ]
    a withdrawal is defined as backwards movement of the needle or the needle+catheter.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 20-90 years
  • Fulfill the criteria of an operation
  • Routine need of an arterial needle

Exclusion Criteria:

  • Lack of patient consent
  • Ultrasound identified plaques in the radial artery or ultrasound verified positive Allens test or traditional positive Allens test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01561196

Anæstesiologisk-Intensiv afdeling I
Aarhus, Jylland, Denmark, 8200
Sponsors and Collaborators
Marlene A Hansen,
Principal Investigator: Marlene Aa Hansen, University of Aarhus

Additional Information:
Responsible Party: Marlene A Hansen,,, Aarhus University Hospital Skejby Identifier: NCT01561196     History of Changes
Other Study ID Numbers: Sloth1
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Marlene A Hansen,, Aarhus University Hospital Skejby:
arteria cannulation

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases