Constructing a Learning Curve in Ultrasound Guided Needling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514604
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : April 30, 2014
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

Constructing a learning curve in ultrasound guided needling

Observational study - How many attempts, with continuous training and feedback, at in-plane ultrasound guided needling in a phantom model are required to attain competence?

The use of ultrasound to enable real-time needle visualisation during regional anaesthesia (placing local anaesthetic, via a needle, near nerves to result in numbing of an area of the body to be operated on) has gained in popularity in recent years. It has been recognised by NICE (National Institute for Clinical Excellence) and guidelines on training have been published, with UK equivalents pending. These call for training in the technique on models or 'phantoms' prior to patient contact.

It is unknown how much experience is necessary to attain competence in a phantom, prior to proceeding to patient contact. One study looking at experiential learning of the technique found a very wide range of experience needed between individuals.

In order to study the effect of any changes in training methods on the learning of the technique it is necessary to have a baseline learning curve.

The investigators are introducing a training package for anaesthetists new to the technique to meet the recommendations on initial phantom based training. Alongside this the investigators aim to gather prospective observational data allowing the investigators to generate a learning curve for the technique. This involves making a video recording of the ultrasound images of approximately 50 sequential attempts at performing a task in a phantom, with ongoing instruction and coaching. The whole training package will take approximately 1 hour.

These video clips will be reviewed and sequential attempts graded for quality of needle visualisation and task completion. This will allow the investigators to use a statistical method, Cumulative Sum (Cusum) analysis, to determine how many attempts were required to attain proficiency. The investigators hope to recruit approximately 20 participants to this pilot study, and from this determine the average amount of training necessary to attain proficiency. Using Cusum analysis requires the use of an acceptable failure rate, usually chosen arbitrarily. To add greater meaning to our findings the investigators will also invite anaesthetists experienced in the technique of in-plane ultrasound guided needling to participate. By measuring the actual success rate of our local trainers the investigators will be able to make a meaningful comparison of the training required to achieve a similar level of success.

Condition or disease
In-plane Ultrasound Guided Needling Training

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Constructing a Learning Curve in Ultrasound Guided Needling - an Observational Study Using Cumulative Sum (Cusum) Analysis
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Little or no experience.
All participants will be asked to declare their degree of experience in the technique being studied. Those declaring themselves as 'New to in-plane ultrasound guided needling. Little or no experience in technique' belong to this cohort and will form the study group.
Regular practitioner. Teaching
Participants declaring themselves as 'Regularly incorporate in-plane ultrasound guided needling in clinical practice. Teaching technique to others' fall within this cohort and form the 'control' group allowing application of a realistic acceptable failure rate to Cusum analysis of the study group.
Some exposure. Infrequent clinical use.
Participants declaring themselves as belonging to this group will not form part of the analysis. They will be welcome to complete training and receive feedback on their performance according to the study protocol.

Primary Outcome Measures :
  1. Attempts required to achieve proficiency as assessed by CUSUM analysis, using data from actual local failure rate. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Relationship between demographic factors or prior experience and the primary outcome [ Time Frame: 1 year ]
    We will record data including gender, grade of anaesthetist, prior exposure to ultrasound guided needling and prior video gaming experience and relate this to attainment of statistical competency during the training and observation.

  2. Relationship between trainers impression of competence and statistical competence? [ Time Frame: 1 year ]
    Trainers will be asked to record their impression of whether a participant has demonstrated competency following training, prior to scoring and analysis of the video recordings. We will compare the trainers impression with the outcome of scoring and cusum analysis for each participant.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Anaesthetists working within the anaesthetic department of Aberdeen Royal Infirmary / Woodend hospitals, Aberdeen.

Inclusion Criteria:

  • Any anaesthetist working within the anaesthetic dept of Aberdeen Royal Infirmary or Woodend Hospital, Aberdeen providing written, informed consent.

Exclusion Criteria:

  • Refusal of consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514604

United Kingdom
Aberdeen Royal Infirmary / Woodend Hospital
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
Principal Investigator: Paul Bourke, MBChB. FRCA NHS Grampian

Responsible Party: University of Aberdeen Identifier: NCT01514604     History of Changes
Other Study ID Numbers: 11/NS/0040
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014

Keywords provided by University of Aberdeen:
Anesthesia and analgesia