Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04911465

Collaborator

Children's National Research Institute (Other)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma	Device: Flashback CRI T1 Tablet

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Trauma Patients All pediatric patients >31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado.	Device: Flashback CRI T1 Tablet Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

Arm

Intervention/Treatment

Pediatric Trauma Patients

All pediatric patients >31 days who meet criteria for highest level trauma activation (Level Red or Level 1) at the Children's Hospital Colorado.

Device: Flashback CRI T1 Tablet

Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.

Outcome Measures

Primary Outcome Measures

Number of participants with abnormal CRI values [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 blood products [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
Number of participants who require operation or angiographic intervention [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Days to 26 Years

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045
2	Children's National Hospital	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

University of Colorado, Denver
Children's National Research Institute

Investigators

Principal Investigator: Steven L Moulton, MD, Children's Hospital Colorado

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04911465

Other Study ID Numbers:

20-2755

First Posted:

Jun 3, 2021

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Colorado, Denver

Pediatric

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Aug 17, 2022