Conventional vs Ultrasound Guided Arteria Cannulation.

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Marlene A Hansen, Stud.med, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01690416
First received: September 13, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention
Disorder of Cardiac Function
Procedure: Traditional palpation technique
Procedure: Ultrasound DNTP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Conventional vs Ultrasound Guided Arteria Cannulation

Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Attempts [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The number of attempts (skin punctures) per catheterization

  • Withdrawals [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The number of withdrawals of the guide-needle per catheterization

  • Time consume [ Time Frame: minutes ] [ Designated as safety issue: No ]
    The time spend for the catheterization procedure

  • Catheters [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The number of utilized catheters


Secondary Outcome Measures:
  • pain [ Time Frame: momentan ] [ Designated as safety issue: No ]
    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.

  • Ease of method for the operator [ Time Frame: momentan ] [ Designated as safety issue: No ]
    The use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure on a Likert scale.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound DNTP
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
Procedure: Traditional palpation technique Procedure: Ultrasound DNTP
Active Comparator: Traditional palpation technique
arteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow
Procedure: Traditional palpation technique Procedure: Ultrasound DNTP

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 compromised flow in either the radial or ulnar artery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690416

Locations
Denmark
Aarhus Universitets Hospital
Aarhus, Jylland, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
Investigators
Principal Investigator: Marlene Aa Hansen, stud.med Anæstesiologisk-Intensiv afd I
  More Information

No publications provided

Responsible Party: Marlene A Hansen, Stud.med, Stud.med, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01690416     History of Changes
Other Study ID Numbers: sloth2, Overlæge Dr. Med Edgar Schnohr
Study First Received: September 13, 2012
Last Updated: September 20, 2012
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on July 28, 2014