Internal Carotid Stenosis
Conditions
Keywords
with surgical indication, Cerebral oximetry, carotid endarterectomy, MRI, ischemic lesion, cost/effectiveness analysis, Neurocognitive Outcome, protein S-100B
Brief summary
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
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
Interventions
OTHERcerebral oximetry monitoring using INVOS™ and hemodynamic optimisation
continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline
OTHERstandard cerebral monitoring and hemodynamic optimisation
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.
Sponsors
Ministry of Health, France
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of new cerebral ischemic lesions | Up to 3 days post-operative | The number of new cerebral ischemic lesions observed on postoperative diffusion MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization length of stay | 4 months post-operative | — |
| Percentage of patient with Neurologic and neurocognitive postoperative disorders | 4 months post-operative | * 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 |
| Percentage of patient with Cardiovascular postoperative disorders | 4 months post-operative | * 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 |
| Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group | 4 months post-operative | — |
| Postoperative quality of life (SF36, EQ5D tests) | 4 months post-operative | 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 |
| Incidence of death 4 month postoperatively | 4 months post-operative | — |
| Percentage of patient with Surgical events | 4 months post-operative | * Percentage of patient with surgical site infection * Percentage of patient with haematoma evacuation |
Countries
France
Outcome results
None listed