Constructing a Learning Curve in Ultrasound Guided Needling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01514604
First received: January 17, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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
In-plane Ultrasound Guided Needling Training

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Constructing a Learning Curve in Ultrasound Guided Needling - an Observational Study Using Cumulative Sum (Cusum) Analysis

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Attempts required to achieve proficiency as assessed by CUSUM analysis, using data from actual local failure rate. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between demographic factors or prior experience and the primary outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Relationship between trainers impression of competence and statistical competence? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Anaesthetists working within the anaesthetic department of Aberdeen Royal Infirmary / Woodend hospitals, Aberdeen.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514604

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

No publications provided

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01514604     History of Changes
Other Study ID Numbers: 11/NS/0040
Study First Received: January 17, 2012
Last Updated: April 29, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
Anesthesia and analgesia
ultrasonography
education

ClinicalTrials.gov processed this record on July 31, 2014