Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

This is an observation study using the Flashback CRI T1 tablet to collect data on compensatory reserve index in pediatric trauma patients. Highest trauma activations at the institution will be enrolled in the study and data will be collected for 12-24 hours based on the patient's hemodynamic status. The device collects data via a pulse oximeter probe. No treatment decisions will be made based on the values of the on the CRI tablet. Data will be retrospectively reviewed to determine if any trends exist that correlate with blood loss, need for operation or blood transfusion.

Study Overview

• Status: Recruiting
• Conditions: Trauma
• Intervention / Treatment: Device: Flashback CRI T1 Tablet

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Marina Reppucci, MD; Phone Number: 7207775371; Email: marina.reppucci@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Marina L Reppucci; Phone Number: 720-777-5371; Email: marina.reppucci@childrenscolorado.org
      • Principal Investigator: Steven Moulton, MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Not yet recruiting
      • Children's National Hospital
      • Contact: Cindy Colson, MSN, RN; Email: ccolson@childrensnational.org
      • Principal Investigator: Randall Burd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 26 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Traumatically injured pediatric patients who present to Children's Hospital Colorado or Children's National Hospital

Description

Inclusion Criteria:

• Children 31 days through 26 years (inclusive) of age who undergo Trauma Red (highest level) activation or Trauma Level 1 (mid-level) activation at Children's Hospital Colorado or Children's National Medical Center.

Exclusion Criteria:

• Pregnant patients
• Incarcerated patients
• Patients who object to study participation at any time
• Limited access to or compromised monitoring sites for non-invasive finger sensors
• Brain death (GCS 3 with fixed, dilated pupils)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric Trauma Patients; All pediatric patients >31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado.	Device: Flashback CRI T1 Tablet; Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal CRI values	Compare CRI values collected by the T1 tablet to standard traditional vital signs, i.e. heart rate and blood pressure, to identify if abnormal CRI values correlated with abnormal traditional vital signs	12-24 hours
Number of participants who require blood products	Compare CRI values collected by the T1 tablet to standard laboratory measures, i.e. hematocrit, to identify if abnormal CRI values correlated with blood loss	12-24 hours
Number of participants who require operation or angiographic intervention	Determine if CRI values collected by the T1 tablet are abnormal in the setting of patients who require operation or angiographic intervention for hemorrhage control	12-24 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's National Research Institute
• Investigators: Principal Investigator: Steven L Moulton, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20-2755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No