Thoracoabdominal TraumaFAST-01NCT02198885
Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma
An observational study of Thoracoabdominal Trauma and Focused Assessment With Sonography for Trauma (FAST), run by University of Saskatchewan at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Trauma, Focused Assessment With Sonography for Trauma (FAST), NanoMaxx Ultrasound System (SonoSite)
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, presenting with blunt or penetrating trauma to the thorax or abdomen, that are being transported by MD Ambulance to Royal University Hospital where the hospital trip is expected to take longer than 10 minutes.
Who may be able to join
- 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
Show all 11Show fewer
- Patient's care will not be compromised in completing a FAST exam - opinion of ER physician
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Thoracoabdominal Trauma, Focused Assessment With Sonography for Trauma (FAST), NanoMaxx Ultrasound System (SonoSite), RP-Xpress (InTouch Technologies)
- Keywords
- FAST, Thoracoabdominal Trauma, Prehospital care, ultrasound, NanoMaxx Ultrasound, RP-Xpress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | This group receives the standard prehospital care en route to hospital, and they do not receive the FAST ultrasound en route. | |
| FAST | This group receives the FAST ultrasound en route to hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Measured: Within 24 hours
Secondary outcomes (1)
Time to intervention
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region, M.D. Ambulance Care Ltd.
- Responsible party
- Principal investigator, Ivar Mendez, University of Saskatchewan
- Investigators
- Ivar Mendez, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198885
- Sponsor's protocol ID
- FAST-01
- Other IDs
- Bio# 14-109
- Acronym
- FAST-01
- Status last verified
- Nov 2017
- First submitted
- 18 Jul 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02198885
- Acronym / sponsor ID
- FAST-01 / FAST-01
- Conditions
- Thoracoabdominal Trauma, Focused Assessment With Sonography for Trauma (FAST), NanoMaxx Ultrasound System (SonoSite), RP-Xpress (InTouch Technologies)
- Keywords
- FAST, Thoracoabdominal Trauma, Prehospital care, ultrasound, NanoMaxx Ultrasound, RP-Xpress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region, M.D. Ambulance Care Ltd.
- Study start
- Aug 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –This group receives the standard prehospital care en route to hospital, and they do not receive the FAST ultrasound en route. |
| FAST | – | –This group receives the FAST ultrasound en route to hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, presenting with blunt or penetrating trauma to the thorax or abdomen, that are being transported by MD Ambulance to Royal University Hospital where the hospital trip is expected to take longer than 10 minutes.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to diagnosis
Time frame: Within 24 hours
1 secondary outcome
Time to intervention
Time frame: Within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Related trials for Thoracoabdominal Trauma
Recruiting
Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA)
Laparoskopic Cholecystectomy, Transversus Abdominis Plane (TAP) Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivar Mendez principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Trauma and Focused Assessment With Sonography for Trauma (FAST), run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.