Clinical trial NCT01561196: Conventional Verses Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
Official title: Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Disease
Keywords: arteria cannulation
Ultrasound
pain
complications
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Pain score on visual analog scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Time spend on the procedure
timeFrame: 1 day
measure: Number of utilized needles
timeFrame: 1 day
measure: number of pricks
timeFrame: 1 day
measure: number of withdrawals
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Anæstesiologisk-Intensiv afdeling I
state: Jylland
Study officials:
affiliation: University of Aarhus
name: Marlene Aa Hansen, stud.med
role: PRINCIPAL_INVESTIGATOR
References: