Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
NCT ID: NCT01415648
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
879 participants
INTERVENTIONAL
2011-04-30
2016-04-30
Brief Summary
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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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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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open NIRS
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
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
Blinded NIRS
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
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting an internal carotid stenosis requiring surgery
* Mini Mental State Examination \>24 during preoperative examination
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yann Le Teurnier, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Besancon University Hospital "Hôpital Jean Minjoz"
Besançon, , France
Bordeaux University Hospital "Haut Lévêque"
Bordeaux, , France
Bordeaux University Hospital "Hôpital Pellegrin"
Bordeaux, , France
Brest University Hospital "La Cavale Blanche"
Brest, , France
Caen University Hospital "Côte de Nacre"
Caen, , France
Dijon University Hospital "Le Bocage"
Dijon, , France
Le Mans Hospital
Le Mans, , France
Hospital de Marie Lannelongue Plessis Robinson
Le Plessis-Robinson, , France
Lyon University Hospital "Hôpital Edouard Herriot"
Lyon, , France
Marseille University Hospital "Hôpital de la Timone"
Marseille, , France
Nantes University Hospital
Nantes, , France
"Nouvelles Cliniques Nantaises"
Nantes, , France
Nice University Hospital "Saint-Roch"
Nice, , France
"Groupe Hospitalier Saint-Joseph"
Paris, , France
"Hôpital Européen Georges Pompidou"
Paris, , France
Reims University Hospital "Robert Debré"
Reims, , France
Rennes University Hospital "Pontchaillou"
Rennes, , France
Strasbourg University Hospital
Strasbourg, , France
Toulouse University Hospital
Toulouse, , France
Countries
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References
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Le Teurnier Y, Rozec B, Degryse C, Levy F, Miliani Y, Godet G, Daccache G, Truc C, Steinmetz E, Ouattara A, Cholley B, Malinovsky JM, Portier D, Dupont G, Liutkus D, Viard P, Pere M, Daumas-Duport B, Magras PA, Vourc'h M; EMOCAR Study Group. Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101388. doi: 10.1016/j.accpm.2024.101388. Epub 2024 May 4.
Other Identifiers
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2010-A01167-32
Identifier Type: OTHER
Identifier Source: secondary_id
STIC/10/02
Identifier Type: -
Identifier Source: org_study_id