A Study to Improve the FAST Ultrasound Exam

Sponsor

The Guthrie Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT02991521

Collaborator

(none)

250

Enrollment

Locations

Arm

76.9

Anticipated Duration (Months)

125

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2017

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

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. [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Robert Packer Hospital	Sayre	Pennsylvania	United States	18840
2	The Guthrie Clinic	Sayre	Pennsylvania	United States	18840

Sponsors and Collaborators

The Guthrie Clinic

Investigators

Principal Investigator: Danielle Pigneri, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Guthrie Clinic

ClinicalTrials.gov Identifier:

NCT02991521

Other Study ID Numbers:

1606-30

First Posted:

Dec 13, 2016

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hemoperitoneum

Study Results

No Results Posted as of Mar 16, 2022