Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma (FAST-01)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to diagnosis	Within 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to intervention	Within 24 hours

Other Outcome Measures

Outcome Measure	Time Frame
Audio quality scores on the visual analog scale	Same day
Video quality scores on the visual analog scale	Same day

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatoon Health Region; M.D. Ambulance Care Ltd.
• Investigators: Principal Investigator: Ivar Mendez, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound; Prehospital care; FAST; Thoracoabdominal Trauma; NanoMaxx Ultrasound; RP-Xpress
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: FAST-01; Bio# 14-109 (Other Identifier: University of Saskatchewan Biomedical Research Ethics Board)