Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy

Study Overview
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Brief Summary
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In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping. The objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days. A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein S-100B

Detailed Description
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After consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre. All patients have a preoperative and a postoperative diffusion cerebral MRI to detect new onset of cerebral ischemic lesion. The amount and the volume of cerebral ischemic lesions will be scored to compare groups. Quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days. A substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein S-100B level and a composite score of neurocognitive tests (measured pre- and postoperatively) The trial will be conducted according to GCP

Official Title
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Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.

Conditions
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Internal Carotid Stenosis

Intervention / Treatment
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* Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation
* Other: standard cerebral monitoring and hemodynamic optimisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (male-female) over 18 y.o. Presenting an internal carotid stenosis requiring surgery Mini Mental State Examination >24 during preoperative examination Informed written consentExclusion Criteria: Exclusion criteria: Severe renal failure or requiring dialysis Liver failure or cirrhosis (Child class ≥ B) or prothrombin activity<50% Heart failure (NYHA ≥ III), left ventricular ejection fraction < 40%, acute coronary syndrome, Associated surgery Pregnancy Contraindication to MRI History of allergy to modified gelatine or starch History of allergy to adhesive part of electrode

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open NIRS<br>continuous per operative cerebral oximetry monitoring (using INVOS™ cerebral oximeter) associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline | Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation<br>* continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline<br>* Other names: INVOS™;|
| Sham Comparator: Blinded NIRS<br>Continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre | Other: standard cerebral monitoring and hemodynamic optimisation<br>* the patient is continously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of new cerebral ischemic lesions | The number of new cerebral ischemic lesions observed on postoperative diffusion MRI | Up to 3 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group |  | 4 months post-operative | 
| Hospitalization length of stay |  | 4 months post-operative | 
| Percentage of patient with Neurologic and neurocognitive postoperative disorders | Percentage of patient with Spatiotemporal disorientation Percentage of patient with aphasia Percentage of patient with Facial paralysis Percentage of patient with Limb sensory or motor deficit Percentage of patient with Seizure Percentage of patient with Balance disorder | 4 months post-operative | 
| Percentage of patient with Cardiovascular postoperative disorders | Percentage of patient with myocardial infaction Percentage of patient with atrial fibrillation or atrial flutter Percentage of patient with acute left ventricle failure Percentage of patient with Uncontrolled high blood pressure | 4 months post-operative | 
| Percentage of patient with Surgical events | Percentage of patient with surgical site infection Percentage of patient with haematoma evacuation | 4 months post-operative | 
| Postoperative quality of life (SF36, EQ5D tests) | SF36 score for quality of life assessment : Physical quality score [Time Frame: Through study completion, 4 month postoperatively] Items from the SF36 (Short Form 36) survey Mental quality score [Time Frame: Through study completion, 4 month postoperatively] Items from the SF36 (Short Form 36) survey EQ5D3L test for quality of life assessment : Quality of life evaluated by the EQ 5D 3L questionnaire [Time Frame: 4 months postoperatively] Quality of life, as evaluated by the use EQ 5D 3L auto-questionnaire | 4 months post-operative | 
| Incidence of death 4 month postoperatively |  | 4 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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with surgical indication, Cerebral oximetry, carotid endarterectomy, MRI, ischemic lesion, cost/effectiveness analysis, Neurocognitive Outcome, protein S-100B