Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Trauma

Treatments: Device: Flashback CRI T1 Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04911465

20-2755

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 31 days to 26 years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 1 patient group

Pediatric Trauma Patients

Description:

All pediatric patients \>31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado.

Treatment:

Device: Flashback CRI T1 Tablet