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

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

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

Study Overview

• Status: Terminated
• Conditions: Internal Carotid Stenosis
• Intervention / Treatment: Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation; Other: standard cerebral monitoring and hemodynamic optimisation

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

• Study Type: Interventional
• Enrollment (Actual): 879
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besancon, France
    • Besancon University Hospital "Hôpital Jean Minjoz"
  • Bordeaux, France
    • Bordeaux University Hospital "Haut Lévêque"
  • Bordeaux, France
    • Bordeaux University Hospital "Hôpital Pellegrin"
  • Brest, France
    • Brest University Hospital "La Cavale Blanche"
  • Caen, France
    • Caen University Hospital "Côte de Nacre"
  • Dijon, France
    • Dijon University Hospital "Le Bocage"
  • Le Mans, France
    • Le Mans Hospital
  • Le Plessis Robinson, France
    • Hospital de Marie Lannelongue Plessis Robinson
  • Lyon, France
    • Lyon University Hospital "Hôpital Edouard Herriot"
  • Marseille, France
    • Marseille University Hospital "Hôpital de la Timone"
  • Nantes, France, 44000
    • Nantes University Hospital
  • Nantes, France
    • "Nouvelles Cliniques Nantaises"
  • Nice, France
    • Nice University Hospital "Saint-Roch"
  • Paris, France
    • "Groupe Hospitalier Saint-Joseph"
  • Paris, France
    • "Hôpital Européen Georges Pompidou"
  • Reims, France
    • Reims University Hospital "Robert Debré"
  • Rennes, France
    • Rennes University Hospital "Pontchaillou"
  • Strasbourg, France
    • Strasbourg University Hospital
  • Toulouse, France
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 consentExclusion Criteria:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 Names: INVOS™
Sham Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of new cerebral ischemic lesions	The number of new cerebral ischemic lesions observed on postoperative diffusion MRI	Up to 3 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 months post-operative
Percentage of patient with Cardiovascular postoperative disorders	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	4 months post-operative
Percentage of patient with Surgical events	Percentage of patient with surgical site infection; Percentage of patient with haematoma evacuation	4 months post-operative
Postoperative quality of life (SF36, EQ5D tests)	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	4 months post-operative
Incidence of death 4 month postoperatively		4 months post-operative

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Yann Le Teurnier, MD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimated): August 12, 2011

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MRI; carotid endarterectomy; Cerebral oximetry; with surgical indication; ischemic lesion; cost/effectiveness analysis; Neurocognitive Outcome; protein S-100B
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: STIC/10/02; 2010-A01167-32 (Other Identifier: Afssaps)