Conventional vs Ultrasound Guided Arteria Cannulation.

Disorder of Cardiac Function Clinical Trial

Official title:

Conventional vs Ultrasound Guided Arteria Cannulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690416
• Other study ID #: sloth2
• Secondary ID: Overlæge Dr. Med
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: May 11, 2015
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2015
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• 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 compromised flow in either the radial or ulnar artery.

Study Design

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

Related Conditions & MeSH terms

• Disorder of Cardiac Function

Intervention

Procedure:
• Traditional palpation technique

• Ultrasound DNTP

Locations

Country	Name	City	State
Denmark	Aarhus Universitets Hospital	Aarhus	Jylland

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attempts	The number of attempts (skin punctures) per catheterization	1 hour	No
Primary	Withdrawals	The number of withdrawals of the guide-needle per catheterization	1 hour	No
Primary	Time consume	The time spend for the catheterization procedure	minutes	No
Primary	Catheters	The number of utilized catheters	1 hour	No
Secondary	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	No
Secondary	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	No