- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991521
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
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
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Sayre, Pennsylvania, United States, 18840
- Robert Packer Hospital
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Sayre, Pennsylvania, United States, 18840
- The Guthrie Clinic
-
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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