N/A
Completed N=23
Bedside Resources to Gauge Intravascular Volume Status
Hypovolemia · Craniosynostoses
Source: ClinicalTrials.gov NCT03915587 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.