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

Primary Purpose

Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused Assessment with Sonography for Trauma (FAST) Examination
No Intervention: Standard of Care - Without the FAST Examination
Sponsored by
James F. Holmes, MD, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Blunt Trauma to Abdomen focused on measuring Child, Wounds and Injuries, Blunt Trauma to Abdomen, Abdomen Injury, Blunt Abdominal Trauma

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria. Inclusion Criteria: 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 Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma Blunt traumatic event with any of the following (regardless of the mechanism): Extremity paralysis Multiple long bone fractures (e.g., tibia and humerus fracture) 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: 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. Penetrating trauma: Patients who are victims of stab or gunshot wounds Traumatic injury occurring > 24 hours prior to the time of presentation to the ED Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed Transferred with FAST exam already performed at outside hospital Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected Known pregnancy Known prisoner Known intra-abdominal injury diagnosed within 30 days prior of this ED visit

Sites / Locations

  • University of California, Davis Medical CenterRecruiting
  • University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
  • Emory University Children's Healthcare of Atlanta
  • Cincinnati Children's Hospital Medical Center
  • The Research Institute at Nationwide Children's Hospital
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Focused Assessment with Sonography for Trauma (FAST) Examination Arm

No Intervention - Standard of Care - Without the FAST Examination

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of abdominal CT scanning
The primary outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Rate of delayed or missed or delayed intra-abdominal injuries
The rate of missed or delayed intra-abdominal injuries (IAI) will be identified and reported for any cases with a delay in diagnosis (i.e., patients diagnosed with IAI in the hospital after ED disposition) or missed IAI (IAI diagnosed after discharge from the ED/hospital).
Identifying variables associated with obtaining abdominal CT scans in very low risk patients with normal FAST examinations
This primary outcome will be a binary indicator (yes/no) for whether the patient with a normal FAST examination who is thought by the clinician to have less than a 1% risk of intra-abdominal injury nonetheless undergoes abdominal CT (outcome of interest).

Secondary Outcome Measures

Hospital length of stay
Length of hospital stay is a continuous variable measured in minutes. The investigators will compare the length of stay between study arms using nonparametric methods from ED arrival to hospital departure.
Rate of Hospitalization
Rate of hospitalization is a categorical variable (yes/no) on whether the patient is hospitalized on initial, enrolling ED visit. The investigators will compare the rate of hospitalization between study arms using categorical statistical methods.
Physician suspicion of intra-abdominal injury
Physician suspicion of intra-abdominal injury is collected after initial physician evaluation for all patients. For those patients who are randomized to the FAST examination this information is collected again after completing the FAST examination. Physician suspicion is collected as follows: Less than 1%, 1-5%, 6-10%, 11-50%, greater than 50%.
Rate of abdominal CT scanning in children 0 to 3 years of age.
In this prespecified age group, the outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Laparotomy (surgery to the abdomen) rate
Laparotomy rate is a binary indicator (yes/no) for whether the patient underwent a laparotomy (surgery to the abdomen) to identify/repair an intra-abdominal injury.

Full Information

First Posted
May 9, 2023
Last Updated
June 13, 2023
Sponsor
James F. Holmes, MD, MPH
Collaborators
Pediatric Emergency Care Applied Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05910567
Brief Title
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Acronym
FAST
Official Title
A Randomized Controlled Trial of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James F. Holmes, MD, MPH
Collaborators
Pediatric Emergency Care Applied Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury, Abdominal Injury, Abdomen, Acute
Keywords
Child, Wounds and Injuries, Blunt Trauma to Abdomen, Abdomen Injury, Blunt Abdominal Trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients meeting enrollment criteria will be randomized to the FAST examination arm or to a standard of care/non-FAST examination arm using computer randomized order of enrollment. Randomization will be stratified by site and age group. Age groups will consist of participants 0 to their 3rd birthday and participants 3 years of age up to their 18th birthday. A minimum of 794 participants will be enrolled in the 0 to younger than 3 years of age group. To ensure concealment, opaque envelopes will be prepared at each study site using the randomization scheme provided by the lead institution. These envelopes will be readily available in the ED, provide the investigator with the randomized assignment, and contain the appropriate data collection form.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focused Assessment with Sonography for Trauma (FAST) Examination Arm
Arm Type
Other
Arm Description
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.
Arm Title
No Intervention - Standard of Care - Without the FAST Examination
Arm Type
Other
Arm Description
Institution will use their standard operating procedures to deliver the usual care for injured patients with blunt abdominal/torso trauma.
Intervention Type
Diagnostic Test
Intervention Name(s)
Focused Assessment with Sonography for Trauma (FAST) Examination
Other Intervention Name(s)
Abdominal Ultrasound
Intervention Description
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
Other
Intervention Name(s)
No Intervention: Standard of Care - Without the FAST Examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of abdominal CT scanning
Description
The primary outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Time Frame
For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours)
Title
Rate of delayed or missed or delayed intra-abdominal injuries
Description
The rate of missed or delayed intra-abdominal injuries (IAI) will be identified and reported for any cases with a delay in diagnosis (i.e., patients diagnosed with IAI in the hospital after ED disposition) or missed IAI (IAI diagnosed after discharge from the ED/hospital).
Time Frame
In hospitalized participants, IAI collection will be captured from the time of assignment until discharge (up to 30 days). For participants discharged from the ED IAI collection will be captured from the time of assignment until 7 days after ED discharge
Title
Identifying variables associated with obtaining abdominal CT scans in very low risk patients with normal FAST examinations
Description
This primary outcome will be a binary indicator (yes/no) for whether the patient with a normal FAST examination who is thought by the clinician to have less than a 1% risk of intra-abdominal injury nonetheless undergoes abdominal CT (outcome of interest).
Time Frame
The binary indicator assessment of yes/no will occur upon discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
Length of hospital stay is a continuous variable measured in minutes. The investigators will compare the length of stay between study arms using nonparametric methods from ED arrival to hospital departure.
Time Frame
Length of hospital stay will be calculated in minutes from the time of ED arrival until the time of discharge from the hospital assessed up to 30 days
Title
Rate of Hospitalization
Description
Rate of hospitalization is a categorical variable (yes/no) on whether the patient is hospitalized on initial, enrolling ED visit. The investigators will compare the rate of hospitalization between study arms using categorical statistical methods.
Time Frame
The assessment of the categorical variable yes/no will occur upon the participants discharge from the Emergency Department or admission to the hospital, an average of 6.5 hours
Title
Physician suspicion of intra-abdominal injury
Description
Physician suspicion of intra-abdominal injury is collected after initial physician evaluation for all patients. For those patients who are randomized to the FAST examination this information is collected again after completing the FAST examination. Physician suspicion is collected as follows: Less than 1%, 1-5%, 6-10%, 11-50%, greater than 50%.
Time Frame
All physician suspicion assessments will occur up to 24 hours after a participants ED presentation
Title
Rate of abdominal CT scanning in children 0 to 3 years of age.
Description
In this prespecified age group, the outcome is the rate of abdominal CT scanning in each study arm, measured for each patient categorically (yes/no) during the Emergency Department stay and initial hospitalization (up to 24 hours).
Time Frame
For the duration of the subject's Emergency Department stay and initial hospitalization (up to 24 hours).
Title
Laparotomy (surgery to the abdomen) rate
Description
Laparotomy rate is a binary indicator (yes/no) for whether the patient underwent a laparotomy (surgery to the abdomen) to identify/repair an intra-abdominal injury.
Time Frame
For the first seven days after the time of injury.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria. Inclusion Criteria: 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 Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma Blunt traumatic event with any of the following (regardless of the mechanism): Extremity paralysis Multiple long bone fractures (e.g., tibia and humerus fracture) 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: 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. Penetrating trauma: Patients who are victims of stab or gunshot wounds Traumatic injury occurring > 24 hours prior to the time of presentation to the ED Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed Transferred with FAST exam already performed at outside hospital Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected Known pregnancy Known prisoner Known intra-abdominal injury diagnosed within 30 days prior of this ED visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James F Holmes, MD, MPH
Phone
916-734-1533
Email
jfholmes@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Kuppermann, MD, MPH
Phone
916-734-1535
Email
nkuppermann@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F Holmes, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan Kuppermann, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Marois, PhD, MPH
Phone
916-734-0373
Email
mtmarois@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Amia Andrade, MPH
Phone
916-703-5652
Email
anandrade@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
James F Holmes, MD, MPH
First Name & Middle Initial & Last Name & Degree
Nathan Kuppermann, MD, MPH
Facility Name
University of Colorado, Anschutz Medical Center and Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiu Lam, MD
Phone
708-790-1185
Email
Hiu.Lam@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Hiu Lam, MD
Facility Name
Emory University Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia R Morris, MD
Phone
404-727-5500
Email
claudia.r.morris@emory.edu
First Name & Middle Initial & Last Name & Degree
Claudia R Morris, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Brenkert, MD
Phone
513-803-2570
Email
Timothy.Brenkert@cchmc.org
First Name & Middle Initial & Last Name & Degree
Timothy Brenkert, MD
Facility Name
The Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delia L Gold, MD
Phone
614-722-4385
Email
delia.gold@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Delia L Gold, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bethsabee Stone, MD
Phone
214-648-3111
Email
Bethsabee.Stone@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Bethsabee Stone, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pecarn.org
Description
Pediatric Emergency Care Applied Research Network

Learn more about this trial

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

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