Conventional Verses Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia
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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 | Phase |
|---|---|---|
|
Heart Disease |
Procedure: arterial catheterisation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Conventional vs. Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia |
- Pain score on visual analog scale [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]The primary outcome is the subjective feeling of pain following the two methods.
- Time spend on the procedure [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Number of utilized needles [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- number of pricks [ Time Frame: 1 day ] [ Designated as safety issue: No ]a prick is defined as eruption of the skin
- number of withdrawals [ Time Frame: 1 day ] [ Designated as safety issue: No ]a withdrawal is defined as backwards movement of the needle or the needle+catheter.
| Enrollment: | 20 |
| Study Start Date: | February 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ultrasound guided arterial cannulation
The arterial needle is placed using ultrasound monitoring for guiding the operator.
|
Procedure: arterial catheterisation
arterial catheterisation in Arterial Radialis
Other Name: ICD10 I95.9
|
|
Active Comparator: Conventional cannulation
the arterial needle is placed using the traditional method and lidocaine. The operator decides where to place the needle in the forearm
|
Procedure: arterial catheterisation
arterial catheterisation in Arterial Radialis
Other Name: ICD10 I95.9
|
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| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Denmark | |
| Anæstesiologisk-Intensiv afdeling I | |
| Aarhus, Jylland, Denmark, 8200 | |
| Principal Investigator: | Marlene Aa Hansen, stud.med | University of Aarhus |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marlene A Hansen, Stud.med, stud.med, Skejby Hospital |
| ClinicalTrials.gov Identifier: | NCT01561196 History of Changes |
| Other Study ID Numbers: | Sloth1 |
| Study First Received: | March 13, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Denmark: Centre for Public Health |
Keywords provided by Skejby Hospital:
|
arteria cannulation Ultrasound pain complications |
Additional relevant MeSH terms:
|
Heart Diseases Cardiovascular Diseases Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013