StrokeNCT03128957
Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry
A study testing IVOS cerebral oximeter, Licox cerebral oxygenation monitor and Cerebral oxygenation in people with Stroke, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- IVOS cerebral oximeter, Licox cerebral oxygenation monitor and Cerebral oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia.
Who cannot join
- Patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative CT scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent English speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlating Brain Tissue Oxygen Tension (PbrO2) and Regional Cerebral Oximetry (rSO2) in Normal Human Brain Under the Conditions of Changing Ventilation Strategy
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 alterations made in ventilation strategy. Correlation will be measured using Pearson's Correlation. P values < 0.05 will be considered statistically significant.
- Conditions
- Stroke
- Being tested
- IVOS cerebral oximeter, Licox cerebral oxygenation monitor, Cerebral oxygenation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVOS cerebral oximeterDevice
Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.
Licox cerebral oxygenation monitorDevice
Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.
Cerebral oxygenationOther
Measuring cerebral oxygenation with varying ventilation strategy
| Study group | Role | What they receive |
|---|---|---|
| Varying cerebral oxygenation with varying ventilation | Experimental | Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen Receives: Device: IVOS cerebral oximeter; Device: Licox cerebral oxygenation monitor; Other: Cerebral oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).
Correlation - correlation coefficient between cerebral oxygenation measured by Licox and INVOS oxygen measurement systems subsequent upon changes in ventilation strategy
Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
[Example of correlation coefficient in CT.gov: NCT02318667]
Measured: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Secondary outcomes (2)
Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction
PbrO2 - measured in millimeters of mercury(mmHg); Steady State PbrO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point
Measured: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction
rSO2 - %saturation; Steady State rSO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point
Measured: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start29 Jun 2017
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Picton, University of Michigan
- Investigators
- Paul Picton, MB ChB, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128957
- Sponsor's protocol ID
- HUM00105648
- Status last verified
- Aug 2022
- First submitted
- 14 Apr 2017
- Last updated
- 1 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Brain Tissue Oxygen Tension (PbrO2) and Regional Cerebral Oximetry (rSO2) in Normal Human Brain Under the Conditions of Changing Ventilation Strategy
- ClinicalTrials.gov ID
- NCT03128957
- Acronym / sponsor ID
- HUM00105648
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 1 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 alterations made in ventilation strategy. Correlation will be measured using Pearson's Correlation. P values < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varying cerebral oxygenation with varying ventilation | Experimental | Device: IVOS cerebral oximeter, Device: Licox cerebral oxygenation monitor, Other: Cerebral oxygenationCompare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia.
Key exclusion criteria (1 listed)
- Patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative CT scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent English speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVOS cerebral oximeterMeasuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. | Device | Varying cerebral oxygenation with varying ventilation |
| Licox cerebral oxygenation monitorMeasuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. | Device | Varying cerebral oxygenation with varying ventilation |
| Cerebral oxygenationMeasuring cerebral oxygenation with varying ventilation strategy | Other | Varying cerebral oxygenation with varying ventilation |
Primary outcome
Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).
Time frame: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Correlation - correlation coefficient between cerebral oxygenation measured by Licox and INVOS oxygen measurement systems subsequent upon changes in ventilation strategy Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem. [Example of correlation coefficient in CT.gov: NCT02318667]
2 secondary outcomes
Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction
Time frame: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction
Time frame: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Picton, MB ChB principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVOS cerebral oximeter, Licox cerebral oxygenation monitor and Cerebral oxygenation in people with Stroke, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2). (time frame: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.