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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast exam | Procedure | Positional change before Fast exam |
|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Pigneri, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States | ||
| The Guthrie Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36519913 | Result | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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All subjects completed traditional FAST examination in the supine position and FASTeR examination regardless of findings on initial FAST examination
Patients recruited from June 2016-October 2020 at 8 designated trauma centers across the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | FAST Examination After Right Sided Roll (FASTeR) | Subjects complete standard FAST then complete FAST examination after Right sided roll (FASTeR) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Fast exam: Positional change before Fast exam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 24 hours |
|
At study visit, up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Fast exam: Positional change before Fast exam |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle A Pigneri, MD, FACS | Medical City Arlington, 3301 Matlock Rd, Arlington, TX 76015 | (502) 387-3117 | dpigneri@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 | Feb 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006465 | Hemoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077564 | Focused Assessment with Sonography for Trauma |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Sayre |
| Pennsylvania |
| 18840 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 182 |
| 0 |
| 182 |
| 0 |
| 182 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000067716 |
| Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |