Trial Outcomes & Findings for A Study to Improve the FAST Ultrasound Exam (NCT NCT02991521)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

182 participants

Primary outcome timeframe

24 hours

Results posted on

2024-03-20

Participant Flow

Patients recruited from June 2016-October 2020 at 8 designated trauma centers across the United States

All subjects completed traditional FAST examination in the supine position and FASTeR examination regardless of findings on initial FAST examination

Participant milestones

Participant milestones
Measure	FAST Examination After Right Sided Roll (FASTeR) Subjects complete standard FAST then complete FAST examination after Right sided roll (FASTeR)
Overall Study STARTED	182
Overall Study COMPLETED	182
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FAST Examination After Right Sided Roll (FASTeR) n=182 Participants 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
Age, Continuous	54 years n=182 Participants
Sex: Female, Male Female	60 Participants n=182 Participants
Sex: Female, Male Male	122 Participants n=182 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FAST Examination After Right Sided Roll (FASTeR) n=182 Participants 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
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

Adverse Events

FAST Examination After Right Sided Roll (FASTeR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danielle A Pigneri, MD, FACS

Medical City Arlington, 3301 Matlock Rd, Arlington, TX 76015

Phone: (502) 387-3117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place