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A Study to Improve the FAST Ultrasound Exam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991521
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemoperitoneum Procedure: Fast exam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

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.
Procedure: Fast exam
Positional change before Fast exam




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991521


Contacts
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Contact: Danielle Pigneri, MD (570)887-4882
Contact: Vicky Hickey (570)887-4882

Locations
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United States, Pennsylvania
Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
The Guthrie Clinic Recruiting
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Danielle Pigneri, MD
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02991521    
Other Study ID Numbers: 1606-30
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hemoperitoneum
Peritoneal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes