Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Last updated: September 25, 2023
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Treatment

Flashback CRI T1 Tablet

Clinical Study ID

NCT04911465
20-2755
  • Ages 31-26
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Flashback CRI T1 Tablet
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

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