Trials / Unknown
UnknownNCT04911465
Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 31 Days – 26 Years
- Healthy volunteers
- —
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Flashback CRI T1 Tablet | Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status. |
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
- First posted
- 2021-06-03
- Last updated
- 2023-09-28
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04911465. Inclusion in this directory is not an endorsement.