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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01415648
First received: July 11, 2011
Last updated: September 26, 2014
Last verified: September 2014

July 11, 2011
September 26, 2014
April 2011
November 2014   (final data collection date for primary outcome measure)
The number of new cerebral ischemic lesions [ Time Frame: Up to one month post-operative ] [ Designated as safety issue: No ]
The number of new cerebral ischemic lesions observed on postoperative diffusion MRI
Same as current
Complete list of historical versions of study NCT01415648 on ClinicalTrials.gov Archive Site
  • Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Hospitalization length of stay and direct medical costs [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Neurologic and neurocognitive postoperative disorders [ Time Frame: 1 month post-operative ] [ Designated as safety issue: No ]
  • Postoperative quality of life (SF36, EQ5D tests) [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Cerebral desaturation threshold assessment [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Internal Carotid Stenosis
  • 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 Name: INVOS™
  • 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.
  • 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
    Intervention: Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation
  • 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
    Intervention: Other: standard cerebral monitoring and hemodynamic optimisation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
978
February 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Yann Le Teurnier, MD +33 2 40 16 53 04 yann.leteurnier@chu-nantes.fr
Contact: Bertrand Rozec, MD +33 2 40 16 53 08 bertrand.rozec@chu-nantes.fr
France
 
NCT01415648
STIC/10/02, 2010-A01167-32
No
Nantes University Hospital
Nantes University Hospital
Ministry of Health, France
Principal Investigator: Yann Le Teurnier, MD CHU Nantes
Nantes University Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP