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OpenTrials
Completed

NCT Number: NCT02198885

Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • M.D. Ambulance Care Ltd.
  • Saskatoon Health Region

Registry information

Official study 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.

Acronym: FAST-01

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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