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

NCT01415648 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 879

Last updated 2023-11-29

No results posted yet for this study

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

Conditions

  • Internal Carotid Stenosis

Interventions

OTHER

cerebral 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

OTHER

standard 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 & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Yann Le Teurnier, MD · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415648 on ClinicalTrials.gov