Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 879
- 试验地点
- 20
- 主要终点
- The number of new cerebral ischemic lesions
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The number of new cerebral ischemic lesions
时间窗: Up to 3 days post-operative
The number of new cerebral ischemic lesions observed on postoperative diffusion MRI
次要结局
- 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 Surgical events(4 months post-operative)
- Postoperative quality of life (SF36, EQ5D tests)(4 months post-operative)
- Percentage of patient with Cardiovascular postoperative disorders(4 months post-operative)
- Incidence of death 4 month postoperatively(4 months post-operative)