Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
- Conditions
- Internal Carotid Stenosis
- Interventions
- Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisationOther: standard cerebral monitoring and hemodynamic optimisation
- Registration Number
- NCT01415648
- Lead Sponsor
- Nantes University Hospital
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 879
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description open NIRS cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation 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 Blinded NIRS standard cerebral monitoring and hemodynamic optimisation 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 disorderPercentage of patient with Surgical events 4 months post-operative * Percentage of patient with surgical site infection
* Percentage of patient with haematoma evacuationPostoperative 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-questionnairePercentage 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 pressureIncidence of death 4 month postoperatively 4 months post-operative
Trial Locations
- Locations (19)
Hospital de Marie Lannelongue Plessis Robinson
🇫🇷Le Plessis Robinson, France
Nice University Hospital "Saint-Roch"
🇫🇷Nice, France
Le Mans Hospital
🇫🇷Le Mans, France
"Nouvelles Cliniques Nantaises"
🇫🇷Nantes, France
"Groupe Hospitalier Saint-Joseph"
🇫🇷Paris, France
"Hôpital Européen Georges Pompidou"
🇫🇷Paris, France
Toulouse University Hospital
🇫🇷Toulouse, France
Reims University Hospital "Robert Debré"
🇫🇷Reims, France
Rennes University Hospital "Pontchaillou"
🇫🇷Rennes, France
Strasbourg University Hospital
🇫🇷Strasbourg, France
Dijon University Hospital "Le Bocage"
🇫🇷Dijon, France
Besancon University Hospital "Hôpital Jean Minjoz"
🇫🇷Besancon, France
Bordeaux University Hospital "Hôpital Pellegrin"
🇫🇷Bordeaux, France
Bordeaux University Hospital "Haut Lévêque"
🇫🇷Bordeaux, France
Brest University Hospital "La Cavale Blanche"
🇫🇷Brest, France
Caen University Hospital "Côte de Nacre"
🇫🇷Caen, France
Marseille University Hospital "Hôpital de la Timone"
🇫🇷Marseille, France
Lyon University Hospital "Hôpital Edouard Herriot"
🇫🇷Lyon, France
Nantes University Hospital
🇫🇷Nantes, France