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NCT03915587 · ClinicalTrials.gov registry record · NA
Bedside Resources to Gauge Intravascular Volume Status
A NA study of Hypovolemia and Craniosynostoses, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT03915587: Completed NA study of Hypovolemia and Craniosynostoses, sponsored by University of Colorado, Denver.
NCT03915587 is a NA study of Hypovolemia and Craniosynostoses that has completed, run by University of Colorado, Denver. The registered enrollment target is 23 participants, below the 59-participant average among 5 other Hypovolemia trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03915587, a NA study of Hypovolemia and Craniosynostoses, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 ra
Conditions Studied
Interventions
- DEVICE CardioQ-EDM and CipherOx-CRI
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2020-03-12 |
| Phase | NA |
What the finished NCT03915587 record still lists
NCT03915587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 59-participant average among 5 other Hypovolemia trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Hypovolemia appearing as the primary indexed condition, and to 1 intervention - of which CardioQ-EDM and CipherOx-CRI is the first listed.
NCT03915587 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03915587 about?
NCT03915587 is a clinical study titled "Bedside Resources to Gauge Intravascular Volume Status". 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 comp...
What is the current status of trial NCT03915587?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2019-04-08. Estimated completion is 2020-03-12.
What conditions does trial NCT03915587 study?
This clinical trial studies the following conditions: Hypovolemia, Craniosynostoses.
What interventions are being tested in trial NCT03915587?
The interventions under investigation include: CardioQ-EDM and CipherOx-CRI (DEVICE).
Who is sponsoring clinical trial NCT03915587?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03915587 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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