A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

NCT ID: NCT05910567

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2027-04-30

Brief Summary

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

Detailed Description

Trauma is a leading cause of death in children in the US. Abdominal trauma accounts for 30% of all pediatric traumatic deaths, second only to traumatic brain injury. Although CT is the reference standard for diagnosing intra-abdominal injury, it is associated with ionizing radiation, inducing malignancies at an estimated rate of 1 per 500 abdominal CT scans in children <5 years and 1 per 600 scans in adolescents. Thus, CT use should be limited to those at non-negligible risk of intra-abdominal injury.

The Focused Assessment with Sonography for Trauma (FAST) examination has also evolved as a diagnostic test for the evaluation for intra-abdominal injury; however, it is used primarily in adults. The FAST examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients. If intraperitoneal fluid is identified following a traumatic injury, this fluid is presumed to be blood (hemoperitoneum). The FAST examination for detection of hemoperitoneum in trauma consists of several images. These include a right hepatorenal interface (Morison's pouch), perisplenic view, and longitudinal and transverse views of the pelvis.

Potential advantages of initial ED evaluation of the injured child using the FAST examination include: 1) bedside evaluation during initial patient ED evaluation and resuscitation; 2) rapid completion of the diagnostic test (within 3-5 minutes); 3) performance of the test and interpretation of results by ED physicians or trauma surgeons caring for the child; 4) no radiation exposure; and 5) reduced patient-care costs compared to routine use of abdominal CT. In adults, a positive FAST examination is the best predictor of intra-abdominal injury. In two adult randomized controlled trials, the use of FAST demonstrated improved patient care by decreasing abdominal CT use, complications and costs. Although the sensitivity of the FAST exam for intra-abdominal injury is lower than CT, as a screening test, it may decrease the need for abdominal CT in both low risk injured adults and children.

The long-term objective of this research study is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality. The specific aims of this proposal are to: 1) perform a randomized, controlled trial of the FAST examination in injured children and compare the frequency of abdominal CT scanning between children who are randomized to the FAST and non-FAST arms; 2) identify if an evaluation strategy including the FAST examination results in a similar frequency of missed or delayed diagnoses of intra-abdominal injuries than a strategy without the FAST examination; and 3) identify patient, physician, and system factors associated with obtaining abdominal CT scans in patients considered low risk for intra-abdominal injuries by the clinician after a negative FAST examination. Such a study has the potential for significant impact in improving the lives of injured children, if found to be successful.

This randomized controlled trial will follow the methods of the one prior randomized controlled trial of FAST in injured children which enrolled 925 injured children at a single center. This study incorporate a total of six centers to increase the sample size and generalizability of the results.

Conditions

Blunt Trauma to Abdomen; Wounds and Injuries; Abdomen Injury; Abdominal Injury; Abdomen, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Focused Assessment with Sonography for Trauma (FAST) Examination Arm

Patients in this arm will under the FAST examination (abdominal ultrasound) for diagnostic purposes to detect the presence of blood in injured patients with blunt abdominal trauma.

Group Type: OTHER

Focused Assessment with Sonography for Trauma (FAST) Examination

Intervention Type: DIAGNOSTIC_TEST

A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.

No Intervention - Standard of Care - Without the FAST Examination

Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma.

Group Type: OTHER

No Intervention: Standard of Care - Without the FAST Examination

Intervention Type: OTHER

Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.

Interventions

Focused Assessment with Sonography for Trauma (FAST) Examination

A bedside Focused Assessment with Sonography for Trauma (FAST) Examination will be conducted on those participants who are randomized to the FAST arm.

Intervention Type: DIAGNOSTIC_TEST

No Intervention: Standard of Care - Without the FAST Examination

Participants randomized to usual care will be evaluated per the standard operating procedures of the institution/site for the condition under study without the FAST exam.

Intervention Type: OTHER

Other Intervention Names

Abdominal Ultrasound

Eligibility Criteria

Inclusion Criteria

1. Blunt torso trauma resulting from a significant mechanism of injury:

• Motor vehicle collision: greater than 60 mph, ejection, or rollover
• Automobile versus pedestrian/bicycle: automobile speed > 25 mph
• Falls greater than 20 feet in height
• Crush injury to the torso
• Physical assault involving the abdomen

2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma

3. Blunt traumatic event with any of the following (regardless of the mechanism):

• Extremity paralysis
• Multiple long bone fractures (e.g., tibia and humerus fracture)

4. History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)

Exclusion Criteria

The following patients will be excluded from the study:

1. Age-adjusted low blood pressure (Hemodynamic instability)

• Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years.

2. Penetrating trauma: Patients who are victims of stab or gunshot wounds

3. Traumatic injury occurring > 24 hours prior to the time of presentation to the ED

4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed

5. Transferred with FAST exam already performed at outside hospital

6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts

7. Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected

8. Known pregnancy

9. Known prisoner

10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Emergency Care Applied Research Network

NETWORK

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James F Holmes, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Nathan Kuppermann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Site Status: RECRUITING

University of Colorado, Anschutz Medical Center and Children's Hospital Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Emory University Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James F Holmes, MD, MPH

Role: CONTACT

jfholmes@ucdavis.edu

916-734-1533

Nathan Kuppermann, MD, MPH

Role: CONTACT

nkuppermann@ucdavis.edu

916-734-1535

Facility Contacts

Maria Marois, PhD, MPH

Role: primary

mtmarois@ucdavis.edu

916-734-0373

Amia Andrade, MPH

Role: backup

anandrade@ucdavis.edu

916-703-5652

Hiu Lam, MD

Role: primary

Hiu.Lam@childrenscolorado.org

708-790-1185

Claudia R Morris, MD

Role: primary

claudia.r.morris@emory.edu

404-727-5500

Timothy Brenkert, MD

Role: primary

Timothy.Brenkert@cchmc.org

513-803-2570

Delia L Gold, MD

Role: primary

delia.gold@nationwidechildrens.org

614-722-4385

Bethsabee Stone, MD

Role: primary

Bethsabee.Stone@utsouthwestern.edu

214-648-3111

Related Links

https://pecarn.org

Pediatric Emergency Care Applied Research Network

Other Identifiers

R01HD102571

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1943798

Identifier Type: -

Identifier Source: org_study_id