Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
NCT04911465 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2023-09-28
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
Interventions
- DEVICE
-
Flashback CRI T1 Tablet
Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.
Sponsors & Collaborators
-
Children's National Research Institute
collaborator OTHER -
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Steven L Moulton, MD · Children's Hospital Colorado
Eligibility
- Min Age
- 31 Days
- Max Age
- 26 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2024-06-30
- Completion
- 2024-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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