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

Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561196
• Other study ID #: Sloth1
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2012
• Last updated: January 30, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Centre for Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Disease

Intervention

Procedure:
• arterial catheterisation
arterial catheterisation in Arterial Radialis

Locations

Country	Name	City	State
Denmark	Anæstesiologisk-Intensiv afdeling I	Aarhus	Jylland

Sponsors (1)

Lead Sponsor	Collaborator
Marlene A Hansen, Stud.med

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on visual analog scale	The primary outcome is the subjective feeling of pain following the two methods.	5 minutes	No
Secondary	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	No
Secondary	Number of utilized needles		1 day	No
Secondary	number of pricks	a prick is defined as eruption of the skin	1 day	No
Secondary	number of withdrawals	a withdrawal is defined as backwards movement of the needle or the needle+catheter.	1 day	No

External Links

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