Bedside Resources to Gauge Intravascular Volume Status

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

April 8, 2019

Primary Completion Date

March 12, 2020

Study Completion Date

March 12, 2020

Conditions
HypovolemiaCraniosynostoses
Interventions
DEVICE

CardioQ-EDM and CipherOx-CRI

A CardioQ-EDM probe will be placed on the day of surgery after induction of general anesthesia. The anesthesiologist will inform the investigator of plans to provide a fluid or blood bolus per clinical judgement in addition to the protocolized 10 ml/kg bolus provided after induction. While the anesthesiologist is preparing to administer volume expansion, a co-investigator will collect pre-fluid bolus data. Measurements will be recorded for data analysis at the completion of the trial. Additionally, a CipherOx-CRI probe will be placed on the patient's index finger (recorded data will be interpreted post hoc) and a bedside ultrasound will be performed by either the principal investigator (PI) or one of two co-investigators to measure the IVC CI. Ultrasound cine-loops will be recorded, and CI will be calculated post-hoc. Data will be recorded on the Data Collection Form for each fluid bolus administered. The PI and co-investigators will manage all aspects of investigational devices.

Trial Locations (1)

80045

Children's Hospital Colorado, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER

NCT03915587 - Bedside Resources to Gauge Intravascular Volume Status | Biotech Hunter | Biotech Hunter