Focused Assessment With Sonography for Trauma (FAST) Clinical Trial
— FAST-01Official title:
Post-marketing, Single-center, Controlled, Open-Label, Feasibility Study Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Patients With Thoracoabdominal Trauma.
| Verified date | November 2017 |
| Source | University of Saskatchewan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch Technologies) provides a means of transmitting ultrasound images, video, and audio to a remote location in real-time. It has been envisioned that this system be used to diagnose trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal blockage during prehospital care; under the guidance of in-hospital physicians, paramedics would perform an Focused Assessment with Sonography for Trauma (FAST) examination while trauma patients are transported to hospital via ambulance. The investigators hypothesize that in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma patients' transportation to hospital will reduce time to diagnosis; thus, preparations by emergency physicians, surgeons, and operating room teams to receive critically injured patients may begin earlier, reducing time to intervention during a critical period in patient care. Data will also be collected regarding quality of images obtained in-ambulance and the interaction between paramedics and physicians using the remote-presence system.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | April 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria for FAST cohort: - Patient is 18 years of age or older - Patient presenting with blunt or penetrating trauma to the thorax or abdomen - Patient transported by MD Ambulance to Royal University Hospital - Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) - Patient will take longer than 10 minutes to transport to hospital - Patient's care will not be compromised in completing a FAST exam - opinion of paramedic - Patient's care will not be compromised in completing a FAST exam - opinion of ER physician Inclusion Criteria for Controls: - Patient is 18 years of age or older - Patient presenting with blunt or penetrating trauma to the thorax or abdomen - Patient transported by MD Ambulance to Royal University Hospital - Patient will take longer than 10 minutes to transport to hospital Exclusion Criteria: - Patients under the age of 18 - Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam - Patients who are not being transported to Royal University Hospital - Patients whose expected transport time from scene to hospital is less than 10 minutes |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Saskatchewan | M.D. Ambulance Care Ltd., Saskatoon Health Region |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Audio quality scores on the visual analog scale | Same day | ||
| Other | Video quality scores on the visual analog scale | Same day | ||
| Primary | Time to diagnosis | Within 24 hours | ||
| Secondary | Time to intervention | Within 24 hours |