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

Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Procedure: arterial catheterisation

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
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Jylland
    • Aarhus, Jylland, Denmark, 8200
      • Anæstesiologisk-Intensiv afdeling I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: ICD10 I95.9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score on visual analog scale	The primary outcome is the subjective feeling of pain following the two methods.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spend on the procedure	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.	1 day
Number of utilized needles		1 day
number of pricks	a prick is defined as eruption of the skin	1 day
number of withdrawals	a withdrawal is defined as backwards movement of the needle or the needle+catheter.	1 day

Collaborators and Investigators

• Sponsor: Marlene A Hansen, Stud.med
• Investigators: Principal Investigator: Marlene Aa Hansen, stud.med, University of Aarhus

Publications and helpful links

Helpful Links

• Aarhus university Hospital, Skejby
• The danish local ethical komité

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasound; pain; complications; arteria cannulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Sloth1