RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

Quick Facts

Study Start:2023-04-17
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05910567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Blunt torso trauma resulting from a significant mechanism of injury:
  2. * Motor vehicle collision: greater than 60 mph, ejection, or rollover
  3. * Automobile versus pedestrian/bicycle: automobile speed \> 25 mph
  4. * Falls greater than 20 feet in height
  5. * Crush injury to the torso
  6. * Physical assault involving the abdomen
  7. 2. Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma
  8. 3. Blunt traumatic event with any of the following (regardless of the mechanism):
  9. * Extremity paralysis
  10. * Multiple long bone fractures (e.g., tibia and humerus fracture)
  11. 4. History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
  1. 1. Age-adjusted low blood pressure (Hemodynamic instability)
  2. * 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.
  3. 2. Penetrating trauma: Patients who are victims of stab or gunshot wounds
  4. 3. Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
  5. 4. Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
  6. 5. Transferred with FAST exam already performed at outside hospital
  7. 6. Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
  8. 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
  9. 8. Known pregnancy
  10. 9. Known prisoner
  11. 10. Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

Contacts and Locations

Study Contact

James F Holmes, MD, MPH
CONTACT
916-734-1533
jfholmes@ucdavis.edu
Nathan Kuppermann, MD, MPH
CONTACT
916-734-1535
nkuppermann@ucdavis.edu

Principal Investigator

James F Holmes, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, Davis
Nathan Kuppermann, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis Medical Center
Sacramento, California, 95817
United States
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: James F. Holmes, MD, MPH

  • James F Holmes, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, Davis
  • Nathan Kuppermann, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Child
  • Wounds and Injuries
  • Blunt Trauma to Abdomen
  • Abdomen Injury
  • Blunt Abdominal Trauma

Additional Relevant MeSH Terms

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