Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Trauma Clinical Trial

Official title:

Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911465
• Other study ID #: 20-2755
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Marina Reppucci, MD
• Phone: 7207775371
• Email: marina.reppucci[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 31 Days to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Device:
• Flashback CRI T1 Tablet
Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with abnormal CRI values	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	12-24 hours
Primary	Number of participants who require blood products	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	12-24 hours
Primary	Number of participants who require operation or angiographic intervention	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	12-24 hours