Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Number of participants with abnormal CRI values
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 31 Days to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Number of participants with abnormal CRI values
Time Frame: 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 operation or angiographic intervention
Time Frame: 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
Number of participants who require blood products
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported