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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01561196
Enrollment
20
Registered
2012-03-22
Start date
2012-02-29
Completion date
2012-12-31
Last updated
2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

arteria cannulation, Ultrasound, pain, complications

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.

Interventions

PROCEDUREarterial catheterisation

arterial catheterisation in Arterial Radialis

Sponsors

Marlene A Hansen, Stud.med
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score on visual analog scale5 minutesThe primary outcome is the subjective feeling of pain following the two methods.

Secondary

MeasureTime frameDescription
Time spend on the procedure1 dayTime 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.
Number of utilized needles1 day
number of pricks1 daya prick is defined as eruption of the skin
number of withdrawals1 daya withdrawal is defined as backwards movement of the needle or the needle+catheter.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026