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CompletedNCT02198885FAST-01Updated Nov 6, 2017

Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma

An observational study in Thoracoabdominal Trauma, Focused Assessment With Sonography for Trauma (FAST) and NanoMaxx Ultrasound System (SonoSite), sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by University of Saskatchewan · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Thoracoabdominal Trauma
  • Focused Assessment With Sonography for Trauma (FAST)
  • NanoMaxx Ultrasound System (SonoSite)
  • RP-Xpress (InTouch Technologies)

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Keywords

  • FAST
  • Thoracoabdominal Trauma
  • Prehospital care
  • ultrasound
  • NanoMaxx Ultrasound
  • RP-Xpress
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 12 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Time to diagnosis

    Time frame: Within 24 hours

Secondary outcomes

  1. Time to intervention

    Time frame: Within 24 hours

Other outcomes

  1. Audio quality scores on the visual analog scale

    Time frame: Same day

  2. Video quality scores on the visual analog scale

    Time frame: Same day

07

Study locations

1 site
  • Royal University Hospital
    Saskatoon, Saskatchewan S7N 0W8, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02198885
Lead sponsor
University of Saskatchewan
Collaborators
Saskatoon Health Region, M.D. Ambulance Care Ltd.
Responsible party
Ivar Mendez (M.D., University of Saskatchewan) — Principal investigator
First posted
Jul 24, 2014
Start date
Aug 2014
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Nov 6, 2017

Study contacts

Ivar Mendez
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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