Skip to main content
Clinical Trials/NCT04911465
NCT04911465
Recruiting
Not Applicable

Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

University of Colorado, Denver2 sites in 1 country300 target enrollmentMay 1, 2021
ConditionsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
University of Colorado, Denver
Enrollment
300
Locations
2
Primary Endpoint
Number of participants with abnormal CRI values
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Number of participants with abnormal CRI values

Time Frame: 12-24 hours

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

Number of participants who require operation or angiographic intervention

Time Frame: 12-24 hours

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

Number of participants who require blood products

Time Frame: 12-24 hours

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

Study Sites (2)

Loading locations...

Similar Trials