Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Recruiting

• Conditions: Trauma
• Interventions: Device: Flashback CRI T1 Tablet

• Registration Number: NCT04911465
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Trauma Patients	Flashback CRI T1 Tablet	All pediatric patients \>31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado.

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal CRI values	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	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	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

Trial Locations

Locations (2)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States