Hypovolemia Clinical Trial
Official title:
Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating Room
NCT number | NCT03915587 |
Other study ID # | 18-2513 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2019 |
Est. completion date | March 12, 2020 |
Verified date | June 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | March 12, 2020 |
Est. primary completion date | March 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 2 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Utility of Compensatory Reserve Index (CRI) Which Ranges From 0-1 in Order to Predict Fluid Responders From Non-responders | Using a delta peak aortic velocity threshold of 10% (measured from CardioQ-EDM) before and after a bolus to define fluid responders (=/>10%) from non-responders (<10%), we will determine the performance of pre-bolus CRI reading which is an index between 0 and 1 (0=poor reserve and 1=excellent reserve) in order to predict fluid responders from non-responders. Measurements will be recorded three times with one minute between measurements and then averaged.
Vital signs analyzed included heart rate, systolic blood pressure, mean arterial pressure, shock index (heart rate/systolic blood pressure), pulse pressure variability, and end-tidal carbon dioxide level. Infants were also monitored with a Compensatory Reserve Index (CRI) monitor, which provides a continuous, individual-specific, beat-to-beat estimate of central volume status, from normovolemia (CRI=1) to decompensation (CRI=0). Each variable's performance was compared using area under the receiver operator curves (AUC). |
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