Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Flashback CRI T1 Tablet

Intervention Type DEVICE

Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

Interventions

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Flashback CRI T1 Tablet

Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

31 Days

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No