N/A N=23 Diagnostic

Bedside Resources to Gauge Intravascular Volume Status

Hypovolemia · Craniosynostoses

Bottom Line

View on ClinicalTrials.gov: NCT03915587 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Utility of Compensatory Reserve Index (CRI) Which Ranges From 0-1 in Order to Predict Fluid Responders From Non-responders — 0.06; 0.05 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CardioQ-EDM and CipherOx-CRI (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Utility of Compensatory Reserve Index (CRI) Which Ranges From 0-1 in Order to Predict Fluid Responders From Non-responders	0.06; 0.05	—

Summary

The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis. After defining these two groups in this single arm prospective trial, the investigators will compare the predictive utility of non-invasive devices such as the CipherOx-Compensatory Reserve Index (CipherOx-CRI) and Inferior Vena Cava Collapsibility Index (IVC CI) to currently employed indices (heart rate, systolic blood pressure, urine output and pulse pressure variability) to gauge the need for additional fluid and ongoing resuscitation. If the CipherOx-CRI or IVC CI proved to be as predictive or better at predicting fluid responders, the investigators hope to replace invasive arterial lines with non-invasive tools to guide resuscitation.

Eligibility Criteria

Inclusion Criteria

Children with craniosynostosis undergoing cranial vault reconstruction

Exclusion Criteria

Children with known underlying cardiac anomalies or cardiac arrhythmias
Weight less than 3 kg
Children who have vasopressors adjusted during a fluid bolus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03915587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.