Cardiac Surgical ProceduresNCT02006212
Impact of Cerebral Monitoring on Neurologic Outcome in Cardiac Surgery
A study testing If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period in people with Cardiac Surgical Procedures, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Neurologic complications after cardiac surgery range over a wide spectrum including postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular accidents (CVA). The incidence of these neurologic events varies depending on the type of surgery and the population studied. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Surgical Procedures
- What is being tested?
- If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Feb 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass and with or without general anesthesia
Who cannot join
- patients sedated and/or intubated before the procedure
- patients who cannot complete the French version of Mini Mental State Examination
- patients who cannot be contacted at 6 months postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Neurologic complications after cardiac surgery range over a wide spectrum including postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular accidents (CVA). The incidence of these neurologic events varies depending on the type of surgery and the population studied. The incidence of PD and/or POCD is further influenced by the type of the neurologic tests used. Moreover, the timing of these tests seems to influence the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep levels of anesthesia on the other hand are major sources of adverse neurological outcomes, both of which can be detected with different non-invasive cerebral monitors.The present investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG) monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every cardiac patient.
This large, prospective, observational study will investigate whether the short- and mid-term neurologic outcome of adult patients undergoing cardiac surgery are in line with observations made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.
Read the detailed description
Whilst the incidence and the perioperative management of neurological complications after cardiac surgery may vary, they share some common risk factors for their occurrence: advanced age, cardiovascular morbidity including peripheral vascular disease, diabetes, previous stroke, preoperative cognitive impairment and dementia.As most of these factors are not modifiable at the time of surgery, conditions that can be controlled in the perioperative period should deserve more focus to prevent the occurrence of neurological problems.
Intraoperative cerebral hypoperfusion is generally accepted as a worsening factor of neurological complications.Besides hypoperfusion states, an overdose of general anesthetics is among intraoperative factors that have been evoked to influence postoperative neurological complications.
The main aim of this study is to know the incidence of POCD and PD in cardiac surgical population and to seek whether the presence and the duration of burst suppressions as detected by NeuroSENSE® on one hand and episodes of cerebral desaturation as detected by bilateral cerebral NIRS on the other hand are risk factors to develop these complications. The magnitude of burst suppression will be recorded as total Area Under the Curve (AUC) of burst suppression of each hemisphere. Cerebral desaturation is defined as AUC of 25% drop of oximetry values as compared to the preinduction values for each hemisphere. We will evaluate whether the concomitant presence of burst suppression together with cerebral oximetry desaturation can predict POCD and PD. Our study will be the first to analyze this point.
Otherwise, with this study the investigators will look for any eventual agreement between the cerebral NIRS and the NeuroSENSE® monitor in terms of detecting cerebral abnormalities. Lastly, in line with previous observations, the investigators will actively look for any intraoperative EEG abnormalities and in particular any sustained pEEG asymmetry that appears together with burst suppressions.
Although the study is observational any frontal severe EEG asymmetry together with the appearance of burst suppression will be carefully evaluated by an experienced anesthesiologist in reading and interpreting processed EEG monitor. The case will be discussed on an multidisciplinary basis and an eventual CT scan will be performed.In the absence of hemorrhage and if large cerebral vessel occlusion is identified, a catheter angiography with an eventual thrombectomy will be realized with the aim to extract the clot.
- Conditions
- Cardiac Surgical Procedures
- Being tested
- If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative periodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cadiac surgical patient; One arm | Other | All patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass necessitating general and/or local anesthesia. If they present any EEG abnormality intraoperatively an immediate cerebral CT scan will be performed and the necessary measures will be taken to reduce the neurologic damage. Receives: Procedure: If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of neurological complications is measured. Area Under the Curve (AUC) of burst suppression of each hemisphere on one hand and AUC of 25% drop of oximetry values as compared to the pre induction values on the other is measured.
Measured: Intraoperatively
Secondary outcomes (2)
The concomitant existence of AUC of burst suppression with AUC of 25% drop of oximetry values are measured.
Measured: Intraoperatively
Agreement between the cerebral NIRS and the NeuroSENSE® monitor in terms of detecting BSR and Oximetry desaturation is measured.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006212
- Sponsor's protocol ID
- SARB 23th November 2013
- Status last verified
- Jan 2016
- First submitted
- 4 Dec 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Momeni M, Baele P, Jacquet LM, Peeters A, Noirhomme P, Rubay J, Docquier MA. Detection by NeuroSENSE Cerebral Monitor of Two Major Neurologic Events During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):1013-5. doi: 10.1053/j.jvca.2013.08.012. Epub 2013 Nov 28. No abstract available.
PubMed 24290745
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cerebral Monitoring on Neurologic Outcome in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02006212
- Acronym / sponsor ID
- SARB 23th November 2013
- Conditions
- Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Dec 2013 (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.
Neurologic complications after cardiac surgery range over a wide spectrum including postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular accidents (CVA). The incidence of these neurologic events varies depending on the type of surgery and the population studied. The incidence of PD and/or POCD is further influenced by the type of the neurologic tests used. Moreover, the timing of these tests seems to influence the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep levels of anesthesia on the other hand are major sources of adverse neurological outcomes, both of which can be detected with different non-invasive cerebral monitors.The present investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG) monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every cardiac patient.
This large, prospective, observational study will investigate whether the short- and mid-term neurologic outcome of adult patients undergoing cardiac surgery are in line with observations made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.
Detailed description
Whilst the incidence and the perioperative management of neurological complications after cardiac surgery may vary, they share some common risk factors for their occurrence: advanced age, cardiovascular morbidity including peripheral vascular disease, diabetes, previous stroke, preoperative cognitive impairment and dementia.As most of these factors are not modifiable at the time of surgery, conditions that can be controlled in the perioperative period should deserve more focus to prevent the occurrence of neurological problems.
Intraoperative cerebral hypoperfusion is generally accepted as a worsening factor of neurological complications.Besides hypoperfusion states, an overdose of general anesthetics is among intraoperative factors that have been evoked to influence postoperative neurological complications.
The main aim of this study is to know the incidence of POCD and PD in cardiac surgical population and to seek whether the presence and the duration of burst suppressions as detected by NeuroSENSE® on one hand and episodes of cerebral desaturation as detected by bilateral cerebral NIRS on the other hand are risk factors to develop these complications. The magnitude of burst suppression will be recorded as total Area Under the Curve (AUC) of burst suppression of each hemisphere. Cerebral desaturation is defined as AUC of 25% drop of oximetry values as compared to the preinduction values for each hemisphere. We will evaluate whether the concomitant presence of burst suppression together with cerebral oximetry desaturation can predict POCD and PD. Our study will be the first to analyze this point.
Otherwise, with this study the investigators will look for any eventual agreement between the cerebral NIRS and the NeuroSENSE® monitor in terms of detecting cerebral abnormalities. Lastly, in line with previous observations, the investigators will actively look for any intraoperative EEG abnormalities and in particular any sustained pEEG asymmetry that appears together with burst suppressions.
Although the study is observational any frontal severe EEG asymmetry together with the appearance of burst suppression will be carefully evaluated by an experienced anesthesiologist in reading and interpreting processed EEG monitor. The case will be discussed on an multidisciplinary basis and an eventual CT scan will be performed.In the absence of hemorrhage and if large cerebral vessel occlusion is identified, a catheter angiography with an eventual thrombectomy will be realized with the aim to extract the clot.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cadiac surgical patient; One arm | Other | Procedure: If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative periodAll patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass necessitating general and/or local anesthesia. If they present any EEG abnormality intraoperatively an immediate cerebral CT scan will be performed and the necessary measures will be taken to reduce the neurologic damage. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients undergoing first or redo cardiac surgery with or without cardiopulmonary bypass and with or without general anesthesia
Key exclusion criteria (3 listed)
- patients sedated and/or intubated before the procedure
- patients who cannot complete the French version of Mini Mental State Examination
- patients who cannot be contacted at 6 months postoperatively
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 |
|---|---|---|
| If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period | Procedure or surgery | cadiac surgical patient; One arm |
Primary outcome
The incidence of neurological complications is measured. Area Under the Curve (AUC) of burst suppression of each hemisphere on one hand and AUC of 25% drop of oximetry values as compared to the pre induction values on the other is measured.
Time frame: Intraoperatively
2 secondary outcomes
The concomitant existence of AUC of burst suppression with AUC of 25% drop of oximetry values are measured.
Time frame: Intraoperatively
Agreement between the cerebral NIRS and the NeuroSENSE® monitor in terms of detecting BSR and Oximetry desaturation is measured.
Time frame: Intraoperatively
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 25 Apr 2017.
- Background: PubMed 24290745Momeni M, Baele P, Jacquet LM, Peeters A, Noirhomme P, Rubay J, Docquier MA. Detection by NeuroSENSE Cerebral Monitor of Two Major Neurologic Events During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):1013-5. doi: 10.1053/j.jvca.2013.08.012. Epub 2013 Nov 28. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period in people with Cardiac Surgical Procedures, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 3 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 25 Apr 2017. 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?
The incidence of neurological complications is measured. Area Under the Curve (AUC) of burst suppression of each hemisphere on one hand and AUC of 25% drop of oximetry values as compared to the pre induction values on the other is measured. (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02006212, which also lists 1 linked publication.
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 25 Apr 2017.