Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

1. Subject eligible for CEA, without progression of symptoms, with low (<4) Anesthesia Risk Assessment
2. Age ≥ 18 years;
3. Written informed consent

Exclusion Criteria

1. Evidence from a CT or MRI scan or from other pre-inclusion investigations of an intracranial haemorrhage, a tumour, encephalitis, or any diagnosis of acute brain focal lesion;
2. Progression or instability of neurological status
3. Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with INR ≥ 1.7, severe pulmonary disease, severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), history of myocardial infarction within the previous 3 months, angina pectoris in the previous 3 months, severe infection with a C-reactive protein > 50 mg/dl, or a clinical diagnosis of sepsis;
4. Blood oxygen saturation below 94%, allowing a maximum of 2 L/min oxygen delivered nasally to achieve this;
5. Bradycardia (<40 beats/min);
6. Body weight > 120 kg;
7. Severe hepatic dysfunction, or severe renal dysfunction;
8. Pregnancy. Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained prior to randomisation;
9. Other serious illness that may confound treatment assessment or increase the risks of cooling;
10. Social or other conditions that according to the investigator's judgement might be a major problem for follow-up.