Monitoring blood flow in injured children
Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
University of Colorado, Denver · NCT04911465
This study looks at how blood flow changes in injured children to see if it can help understand their need for surgery or blood transfusions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 31 Days to 26 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04911465 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on the compensatory reserve index in pediatric trauma patients using the Flashback CRI T1 tablet. The study enrolls children who experience the highest levels of trauma activation at participating hospitals and monitors their hemodynamic status for 12-24 hours. Data is gathered through a pulse oximeter probe, and no treatment decisions will be influenced by the collected values. The aim is to retrospectively analyze trends that may correlate with blood loss, the need for surgery, or blood transfusions.
Who should consider this trial
Good fit: Ideal candidates are children aged 31 days to 26 years who experience high-level trauma activations at the participating hospitals.
Not a fit: Patients who are pregnant, incarcerated, or have brain death will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of hemodynamic responses in pediatric trauma, potentially leading to improved management strategies.
How similar studies have performed: While this approach is observational and may not have direct precedents, similar studies in adult trauma have shown the importance of hemodynamic monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aurora, Colorado and 1 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
- Children's National Hospital — Washington, District of Columbia, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Steven L Moulton, MD — Children's Hospital Colorado
- Study coordinator: Marina Reppucci, MD
- Email: marina.reppucci@childrenscolorado.org
- Phone: 7207775371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.