Hemoperitoneum
Conditions
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.
Interventions
PROCEDUREFast exam
Positional change before Fast exam
Sponsors
The Guthrie Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from June 2016-October 2020 at 8 designated trauma centers across the United States
Pre-assignment details
All subjects completed traditional FAST examination in the supine position and FASTeR examination regardless of findings on initial FAST examination
Participants by arm
| Arm | Count |
|---|---|
| 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 | 182 |
| Total | 182 |
Baseline characteristics
| Characteristic | FAST Examination After Right Sided Roll (FASTeR) | — |
|---|---|---|
| Age, Continuous | 54 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 60 Participants | — |
| Sex: Female, Male Male | 122 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 182 |
| other Total, other adverse events | 0 / 182 |
| serious Total, serious adverse events | 0 / 182 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FAST Examination After Right Sided Roll (FASTeR) | 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. | 65 Participants |