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NCT03128957 · ClinicalTrials.gov registry record · NA
Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03128957 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 12 participants.
The verdict
NCT03128957, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood in uninjured, normal human brain. Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia will be recruited following written informed consent obtained by a study team member during their preoperative evaluation. BIS and rSO2 optodes will be applied, before induction of anesthesia, by a single researcher on both sides of the patient's forehead, as recommended by the manufacturer. General anesthesia will be maintained by total intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien, Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into an area of normal brain within the tumor excision canal by the attending neurosurgeon. During a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded as a "snap-shot". A sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in PbrO2 and changes in rSO2 subsequent on al
Interventions
- DEVICE IVOS cerebral oximeter
- DEVICE Licox cerebral oxygenation monitor
- OTHER Cerebral oxygenation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2021-06-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03128957
The ClinicalTrials.gov registry entry for NCT03128957 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IVOS cerebral oximeter is the first listed.
NCT03128957 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03128957 about?
NCT03128957 is a clinical study titled "Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry". Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in routine neurosurgery and has bee...
What is the current status of trial NCT03128957?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2017-06-29. Estimated completion is 2021-06-22.
What interventions are being tested in trial NCT03128957?
The interventions under investigation include: IVOS cerebral oximeter (DEVICE), Licox cerebral oxygenation monitor (DEVICE), Cerebral oxygenation (OTHER).
Who is sponsoring clinical trial NCT03128957?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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