Adding remote ultrasound "knobology" control to remote just-in-time telementored trauma ultrasound: a randomised controlled trial
| ISRCTN | ISRCTN88998033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88998033 |
| Secondary identifying numbers | 20949 |
- Submission date
- 12/02/2015
- Registration date
- 23/02/2015
- Last edited
- 25/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Trauma Services
1403 29 St NW
Calgary
T2N 2T9
Canada
| Phone | 4039442888 |
|---|---|
| andrew.kirkpatrick@albertahealthservices.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Medical ultrasound remote access/control interface testing requirements for a graphic user interface (GUI) |
| Study objectives | 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(s) | University of Calgary Office of Medical Bioethics, 06/07/2007, ref: 20949 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 29/10/2014 |
| Completion date | 30/03/2015 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 101 |
| Key inclusion criteria | 1. Pre-hospital care provider 2. Willingness to participate 3. Command of English |
| Key exclusion criteria | 1. Any prior experience with ultrasound 2. Unwilling to participate 3. Unable to speak English |
| Date of first enrolment | 29/10/2014 |
| Date of final enrolment | 30/05/2015 |
Locations
Countries of recruitment
- Canada
Study participating centre
1403 29 St NW
Calgary
T2N 2T9
Canada
Sponsor information
Government
Operational Space Medicine
Space Exploration
6767, Route de l'Aéroport
Longueuil (St-Hubert), Quebec
J3Y 8Y9
Canada
| Phone | (450) 926-4734 |
|---|---|
| pat.sullivan@asc-csa.gc.ca | |
| Website | www.asc-csa.gc.ca |
"ROR" |
https://ror.org/03a1gte98 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Agence Spatiale Canadienne, CSA, ASC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | 25/06/2020 | Yes | No |
Editorial Notes
25/06/2020: Publication reference and total final enrolment number added.
