Conventional vs Ultrasound Guided Arteria Cannulation.

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Cardiac Function
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Jylland
    • Aarhus, Jylland, Denmark, 8200
      • Aarhus Universitets Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• 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 compromised flow in either the radial or ulnar artery.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attempts	The number of attempts (skin punctures) per catheterization	1 hour
Withdrawals	The number of withdrawals of the guide-needle per catheterization	1 hour
Time consume	The time spend for the catheterization procedure	minutes
Catheters	The number of utilized catheters	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	momentan
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.	momentan

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Investigators: Principal Investigator: Marlene Aa Hansen, stud.med, Anæstesiologisk-Intensiv afd I

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (ESTIMATE): September 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: sloth2; Overlæge Dr. Med Edgar Schnohr (OTHER_GRANT: Overlæge Dr. Med Edgar Schnohr)