Plain English Summary
Background and study aims
Traumatic injury remains the leading cause of potentially preventable death in the Western world, especially in the Arctic, and is one, if not the most feared, pathology in Space Medicine. Resuscitative ultrasound is becoming a universal tool in emergency medicine that can capture a vast array of injuries and deranged physiology in the critically injured. An unfortunate practical reality however, is that ultrasound is very user dependant. Space Medicine has led the innovation however, in using advanced telecommunications to allow experts not at the scene of the trauma (remote expert) to guide non-experts to use on-scene ultrasound equipment to get clinically meaningful images. Furthermore, the Trauma Services group at the University of Calgary has led the world in examining the use of this technology in a clinical setting on earth. The Ultrasonix Corporation, under contract to the Canadian Space Agency (CSA), has developed an advanced Graphic User Interface (GUI) which allows a expert to control the ultrasound settings of a Ultrasonix Ultrasound remotely and to communicate with the non-expert user over a unique voice and video connection. A consistent finding of this experience has been the sentiment that being able to transfer the responsibility of controlling the ultrasound settings (knobology) from the on-site inexperienced user to the remote expert. The aim of this study is to test whether the use of a remote controlled GUI improve the usefulness of emergency “just-in-time” remote telementored ultrasound as measured by examining the accuracy of the examination
Who can participate?
Firefighters from the city of Edmonton that have not had any prior experience with trauma ultrasound.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 perform a telementored ultrasound examination on an ultrasound phantom (a training model that gives realistic ultrasound images when scanned) to which fluid has been added. Those in group 2 perform a telementored ultrasound examination on an ultrasound phantom to which fluid has not been added. All participants are mentored by remote ultrasound experts who can view their hand movements and provide 2-way communication. The intervention being randomized is the remote control of the ultrasound machine "knobology" by the remote mentor or not which is randomly assigned. The accuracy of the mentored examination is determined by the known “truth” regarding the volume of fluid added to the phantom. The time needed to complete the examination is also recorded with and without GUI assistance. All volunteers and remote mentors are asked to complete questionnaires for each examination in which all responses will be anonymous, regarding how useful they found the technique and the GUI, any suggested modifications to the GUI, and other general comments.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Foothills Medical Centre, Calgary (Canada)
When is the study starting and how long is it expected to run for?
October 2014 to March 2015
Who is funding the study?
Canadian Space Agency
Who is the main contact?
Professor Andrew Kirkpatrick
andrew.kirkpatrick@albertahealthservices.ca
Trial website
Contact information
Type
Scientific
Primary contact
Professor Andrew Kirkpatrick
ORCID ID
Contact details
Trauma Services
1403 29 St NW
Calgary
T2N 2T9
Canada
4039442888
andrew.kirkpatrick@albertahealthservices.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20949
Study information
Scientific title
Medical ultrasound remote access/control interface testing requirements for a graphic user interface (GUI)
Acronym
Study hypothesis
The aim is to test the usefulness of a remote ultrasound examination that utilizes a graphic user interface to assist with the knobology of the remote ultrasound machine.
Ethics approval
University of Calgary Office of Medical Bioethics, 06/07/2007, ref: 20949
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Trauma Resuscitation
Intervention
Pre-hospital responders unfamiliar with trauma ultrasound will be randomized to perform a tele-mentored ultrasound examination on an ultrasound phantom to which fluid has been randomly added or not. They will be mentored by remote ultrasound experts who can view their hand movements and provide 2-way communication. The intervention being randomized is the remote control of the ultrasound machine "knobology" by the remote mentor or not which will be randomly assigned
Intervention type
Device
Phase
Drug names
Primary outcome measure
The accuracy of the mentored examination to detect any free fluid within the phantom (Binary yes/no determination) with and without GUI assistance.
Secondary outcome measures
The relative user satisfaction will be assessed using a previously verified post-examination satisfaction survey with the Likert scores compared for those using the GUI versus not.
Overall trial start date
29/10/2014
Overall trial end date
30/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pre-hospital care provider
2. Willingness to participate
3. Command of English
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Any prior experience with ultrasound
2. Unwilling to participate
3. Unable to speak English
Recruitment start date
29/10/2014
Recruitment end date
30/05/2015
Locations
Countries of recruitment
Canada
Trial participating centre
Foothills Medical Centre
Trauma Services
1403 29 St NW
Calgary
T2N 2T9
Canada
Sponsor information
Organisation
Canadian Space Agency
Sponsor details
Operational Space Medicine
Space Exploration
6767
Route de l'Aéroport
Longueuil (St-Hubert)
Quebec
J3Y 8Y9
Canada
(450) 926-4734
pat.sullivan@asc-csa.gc.ca
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Canadian Space Agency
Alternative name(s)
Agence Spatiale Canadienne, CSA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
We intend to produce a peer reviewed manuscript for presentation at a major trauma conference followed by submission to a peer reviewed Journal
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list