Cerebral Oxygen SaturationNCT01424800
Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry
A study testing A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation. in people with Cerebral Oxygen Saturation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cerebral Oxygen Saturation
- What is being tested?
- A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-100 years, scheduled for elective cardiac surgery, written informed consent.
Who cannot join
- History of cerebrovascular disease or symptomatic carotid artery stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in systemic flow, in MAP, or in both variables at the same time have the greatest impact on the cerebral oxygen saturation.
Read the detailed description
Cerebral autoregulation is defined as the whole of regulatory mechanisms that maintains a constant cerebral blood flow (CBF) during changes in cerebral perfusion pressure (CPP). Cerebrovascular resistance adjusts when CPP changes in order to keep CBF constant. In contrast with this concept of pressure-mediated autoregulation, it is suggested that cerebral autoregulation is focused on maintaining homeostasis of the cerebral metabolic rate of oxygen (CMRO2). We assume that both flow and pressure contribute to the regulation of CMRO2.
Assessment of cerebral oxygenation - Cerebral oxygen saturation will be monitored with near-infrared spectroscopy (NIRS). NIRS allows simple, continuous and non-invasive measurement of cerebral oxygen saturation (ScO2)and primarily cerebral venous saturation. Cerebral oxygen saturation will be monitored with a FDA-approved devices: INVOS 5100 (Somanetics Corporation, Troy, MI, USA).
To study the effects of changes in pressure and in flow, we need a condition where we can alter these variables separately and in a controlled manner. Therefore this study will be performed during cardiopulmonary bypass (CPB). Pressure will be varied with the administration of routinely used vasoactive substances, while flow will be varied by altering the pump flow manually. We hypothesize that if we change one parameter (pressure or flow), a compensatory mechanism will preserve the CMRO2 homeostasis, with no change in ScO2. On the other hand, if we change both pressure and flow, we expect a significant effect on cerebral oxygen saturation. With 20 % changes in pressure and/or flow, we expect a change in NIRS values of approximately 5 %. Previous studies showed that this kind of reduction is well tolerated by the brain. This means that the proposed changes are within the normal physiological range, and will have no adverse effects.
- Conditions
- Cerebral Oxygen Saturation
- Being tested
- A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.Device
When the patient is on CPB, pressure and/or flow will be changed while continuously measuring ScO2. Temperature, CO2 , arterial oxygen content, hematocrit and anesthesia will be kept constant during the measurements. First, baseline MAP (mean arterial pressure), baseline ScO2 and baseline central venous oxygen saturation (SvO2) are determined. With the interventions, we will induce a change of 20% in MAP and/or flow. This is within the normal range during operations. Changes in blood pressure will be obtained by the use of vasoactive agents (sodiumnitroprusside for blood pressure decrease and phenylephrine for blood pressure increase). Flow is regulated by manual control of the pump flow. Values of the different variables will be obtained after a 5 min stabilisation period. Flow/pressure interventions will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| change in blood pressure and blood flow | Experimental | 34 patients will form the experimental group, in which changes of blood pressure and blood flow will be induced and monitored. Receives: Device: A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Changes in blood flow during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.
Measured: during the entire surgery
Blood pressure
Changes in blood pressure during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.
Measured: during the entire surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annelies Moerman, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424800
- Sponsor's protocol ID
- 2011/208
- Status last verified
- Mar 2012
- First submitted
- 22 Aug 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry
- ClinicalTrials.gov ID
- NCT01424800
- Acronym / sponsor ID
- 2011/208
- Conditions
- Cerebral Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in systemic flow, in MAP, or in both variables at the same time have the greatest impact on the cerebral oxygen saturation.
Detailed description
Cerebral autoregulation is defined as the whole of regulatory mechanisms that maintains a constant cerebral blood flow (CBF) during changes in cerebral perfusion pressure (CPP). Cerebrovascular resistance adjusts when CPP changes in order to keep CBF constant. In contrast with this concept of pressure-mediated autoregulation, it is suggested that cerebral autoregulation is focused on maintaining homeostasis of the cerebral metabolic rate of oxygen (CMRO2). We assume that both flow and pressure contribute to the regulation of CMRO2.
Assessment of cerebral oxygenation - Cerebral oxygen saturation will be monitored with near-infrared spectroscopy (NIRS). NIRS allows simple, continuous and non-invasive measurement of cerebral oxygen saturation (ScO2)and primarily cerebral venous saturation. Cerebral oxygen saturation will be monitored with a FDA-approved devices: INVOS 5100 (Somanetics Corporation, Troy, MI, USA).
To study the effects of changes in pressure and in flow, we need a condition where we can alter these variables separately and in a controlled manner. Therefore this study will be performed during cardiopulmonary bypass (CPB). Pressure will be varied with the administration of routinely used vasoactive substances, while flow will be varied by altering the pump flow manually. We hypothesize that if we change one parameter (pressure or flow), a compensatory mechanism will preserve the CMRO2 homeostasis, with no change in ScO2. On the other hand, if we change both pressure and flow, we expect a significant effect on cerebral oxygen saturation. With 20 % changes in pressure and/or flow, we expect a change in NIRS values of approximately 5 %. Previous studies showed that this kind of reduction is well tolerated by the brain. This means that the proposed changes are within the normal physiological range, and will have no adverse effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| change in blood pressure and blood flow | Experimental | Device: A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.34 patients will form the experimental group, in which changes of blood pressure and blood flow will be induced and monitored. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 21-100 years, scheduled for elective cardiac surgery, written informed consent.
Key exclusion criteria (1 listed)
- History of cerebrovascular disease or symptomatic carotid artery stenosis.
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 |
|---|---|---|
| A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.When the patient is on CPB, pressure and/or flow will be changed while continuously measuring ScO2. Temperature, CO2 , arterial oxygen content, hematocrit and anesthesia will be kept constant during the measurements. First, baseline MAP (mean arterial pressure), baseline ScO2 and baseline central venous oxygen saturation (SvO2) are determined. With the interventions, we will induce a change of 20% in MAP and/or flow. This is within the normal range during operations. Changes in blood pressure will be obtained by the use of vasoactive agents (sodiumnitroprusside for blood pressure decrease and phenylephrine for blood pressure increase). Flow is regulated by manual control of the pump flow. Values of the different variables will be obtained after a 5 min stabilisation period. Flow/pressure interventions will be randomized. | Device | change in blood pressure and blood flow |
Primary outcome
Blood flow
Time frame: during the entire surgery
Changes in blood flow during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.
Blood pressure
Time frame: during the entire surgery
Changes in blood pressure during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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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.
Annelies Moerman, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation. in people with Cerebral Oxygen Saturation, run by University Hospital, Ghent at 1 site in Belgium.
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 6 Mar 2012. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood flow (time frame: during the entire surgery). The study lists 2 primary outcomes in all. 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 6 Mar 2012.