A Study to Improve the FAST Ultrasound Exam

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified December 2016 by The Guthrie Clinic

Sponsor:

Information provided by (Responsible Party):

The Guthrie Clinic

ClinicalTrials.gov Identifier:

NCT02991521

First received: November 28, 2016

Last updated: December 9, 2016

Last verified: December 2016

History of Changes

Purpose

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	Intervention
Hemoperitoneum	Procedure: Fast exam


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Further study details as provided by The Guthrie Clinic:

Primary Outcome Measures:

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 ]


Estimated Enrollment:	2500
Study Start Date:	December 2016
Estimated Study Completion Date:	June 2019
Estimated Primary Completion Date:	January 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02991521

Contacts


Contact: Danielle Pigneri, MD	(570)887-4882
Contact: Alexander Johnston, MD

Locations


United States, Pennsylvania
The Guthrie Clinic
Sayre, Pennsylvania, United States, 18840

Sponsors and Collaborators

The Guthrie Clinic

Investigators


Principal Investigator:	Danielle Pigneri, MD

More Information


Responsible Party:	The Guthrie Clinic
ClinicalTrials.gov Identifier:	NCT02991521 History of Changes
Other Study ID Numbers:	1606-30
Study First Received:	November 28, 2016
Last Updated:	December 9, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Hemoperitoneum Peritoneal Diseases Digestive System Diseases Hemorrhage Pathologic Processes

ClinicalTrials.gov processed this record on July 14, 2017

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