Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04911465

Conditions

Trauma

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Interventions

Flashback CRI T1 Tablet

Study Details

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

Study ID

NCT04911465

Start date

May 1, 2021

Status verified date

Sep, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Flashback CRI T1 Tablet

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

Primary outcome measure

  • Number of participants with abnormal CRI values [ Time Frame: 12-24 hours ]
  • Number of participants who require blood products [ Time Frame: 12-24 hours ]
  • Number of participants who require operation or angiographic intervention [ Time Frame: 12-24 hours ]

Central Contacts and Locations

Central contacts

Marina Reppucci, MD

7207775371marina.reppucci@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Marina L Reppucci

720-777-5371marina.reppucci@childrenscolorado.org

Principal Investigator:

Steven Moulton, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Keywords

  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-09-28.