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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marlene A Hansen, Stud.med, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01561196
First received: March 13, 2012
Last updated: January 30, 2013
Last verified: January 2013
  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 Phase
Heart Disease
Procedure: arterial catheterisation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Pain score on visual analog scale [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    The primary outcome is the subjective feeling of pain following the two methods.


Secondary Outcome Measures:
  • Time spend on the procedure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Number of utilized needles [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • number of pricks [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    a prick is defined as eruption of the skin

  • number of withdrawals [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    a withdrawal is defined as backwards movement of the needle or the needle+catheter.


Enrollment: 20
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 positive Allens test or traditional positive Allens test
  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: NCT01561196

Locations
Denmark
Anæstesiologisk-Intensiv afdeling I
Aarhus, Jylland, Denmark, 8200
Sponsors and Collaborators
Marlene A Hansen, Stud.med
Investigators
Principal Investigator: Marlene Aa Hansen, stud.med University of Aarhus
  More Information

Additional Information:
No publications provided

Responsible Party: Marlene A Hansen, Stud.med, stud.med, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01561196     History of Changes
Other Study ID Numbers: Sloth1
Study First Received: March 13, 2012
Last Updated: January 30, 2013
Health Authority: Denmark: Centre for Public Health

Keywords provided by Aarhus University Hospital Skejby:
arteria cannulation
Ultrasound
pain
complications

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014