Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04911465

Enrollment

300

Registered

2021-06-03

Start date

2021-05-01

Completion date

2024-06-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

Pediatric

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.

Interventions

DEVICEFlashback CRI T1 Tablet

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

31 Days to 26 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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 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
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

Countries

United States

Contacts

Primary ContactMarina Reppucci, MD

marina.reppucci@childrenscolorado.org7207775371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026