NCT02991521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

November 28, 2016

Results QC Date

March 24, 2023

Last Update Submit

February 21, 2024

Conditions

Hemoperitoneum

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

FAST examination after Right sided roll (FASTeR)

EXPERIMENTAL

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

Interventions

Fast examPROCEDURE

Positional change before Fast exam

FAST examination after Right sided roll (FASTeR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

Related Publications (1)

  • Cibulas Shumway M, Granet J, Solomon RJ, Parreco JP, Lee SK, Pigneri DA; FASTeR Study Group. Using Right-Sided Roll to Improve Reliability of Focused Assessment with Sonography in Trauma: An Eastern Association for the Surgery of Trauma Multicenter Prospective Study. J Am Coll Surg. 2023 Jan 1;236(1):99-104. doi: 10.1097/XCS.0000000000000443. Epub 2022 Dec 15.

    PMID: 36519913RESULT

Related Links

MeSH Terms

Conditions

Hemoperitoneum

Interventions

Focused Assessment with Sonography for Trauma

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Danielle A Pigneri, MD, FACS
Organization
Medical City Arlington, 3301 Matlock Rd, Arlington, TX 76015
dpigneri@gmail.com
(502) 387-3117

Study Officials

  • Danielle Pigneri, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 13, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2022

Study Completion

January 1, 2023

Last Updated

March 20, 2024

Results First Posted

March 20, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)