Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

NCT04911465 | Unknown FDA Device

• 1 other identifier: 20-2755
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Trauma

Keywords

Pediatric

Outcome Measures

Primary Outcomes (3)

• Number of participants with abnormal CRI values

  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

  12-24 hours

• Number of participants who require blood products

  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

  12-24 hours

• Number of participants who require operation or angiographic intervention

  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

  12-24 hours

Study Arms (1)

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.

Device: Flashback CRI T1 Tablet

Interventions

Flashback CRI T1 Tablet DEVICE

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

Pediatric Trauma Patients

Eligibility Criteria

• Age: 31 Days - 26 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Traumatically injured pediatric patients who present to Children's Hospital Colorado or Children's National Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's National Research Institute: collaborator

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Steven L Moulton, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Reppucci, MD

CONTACT

7207775371; marina.reppucci@childrenscolorado.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 3, 2021
• Study Start: May 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)