A Study to Improve the FAST Ultrasound Exam

February 21, 2024 updated by: The Guthrie Clinic

Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination

This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Danielle Pigneri, MD
  • Phone Number: (570)887-4882

Study Contact Backup

  • Name: Vicky Hickey
  • Phone Number: (570)887-4882

Study Locations

    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
      • Sayre, Pennsylvania, United States, 18840
        • The Guthrie Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma.

Exclusion Criteria:

  • Pregnant females
  • Prisoners
  • Patients with prohibitive right sided chest trauma
  • Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination
  • Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAST examination after Right sided roll (FASTeR)
Subjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated.
Positional change before Fast exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Screening Positive for Blood Around the Abdominal Organs (Hemoperitoneum) After Trauma, as Assessed by Focused Assessment With Sonography for Trauma (FAST), a Rapid Bedside Ultrasound Examination.
Time Frame: 24 hours
Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Danielle Pigneri, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimated)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1606-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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