Conventional vs Ultrasound Guided Arteria Cannulation.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Disorder of Cardiac Function |
Procedure: Traditional palpation technique Procedure: Ultrasound DNTP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | Conventional vs Ultrasound Guided Arteria Cannulation |
- Attempts [ Time Frame: 1 hour ] [ Designated as safety issue: No ]The number of attempts (skin punctures) per catheterization
- Withdrawals [ Time Frame: 1 hour ] [ Designated as safety issue: No ]The number of withdrawals of the guide-needle per catheterization
- Time consume [ Time Frame: minutes ] [ Designated as safety issue: No ]The time spend for the catheterization procedure
- Catheters [ Time Frame: 1 hour ] [ Designated as safety issue: No ]The number of utilized catheters
- pain [ Time Frame: momentan ] [ Designated as safety issue: No ]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.
- Ease of method for the operator [ Time Frame: momentan ] [ Designated as safety issue: No ]The use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure on a Likert scale.
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Marlene A Hansen, Stud.med, Stud.med, Skejby Hospital |
| ClinicalTrials.gov Identifier: | NCT01690416 History of Changes |
| Other Study ID Numbers: | sloth2, Overlæge Dr. Med Edgar Schnohr |
| Study First Received: | September 13, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | Denmark: Ethics Committee |
ClinicalTrials.gov processed this record on May 19, 2013