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Effect of altering inspired oxygen concentrations on cerebral oxygenation during awake carotid surgery - O2 and cerebral oximetry during awake CEA

Conditions
Carotid endarterectomy is an operation performed on patients with a symptomatic stenosis of the internal carotid artery. Such patients have usually presented with stroke or transient ischaemic attack. The degree of stenosis is estimated by Doppler ultrasound. Patients are only operated on if there is 70-99% stenosis.
Registration Number
EUCTR2005-004209-27-GB
Lead Sponsor
Oxford Radcliffe Hospitals NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
15
Inclusion Criteria

All patients undergoing carotid endarterectomy under regional anaesthesia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient refusal for regional anaesthesia
Patient refusal to participate in the trial
Non-English speaking (this would preclude regional anaesthesia techniques anyway)
Complete contralateral internal carotid artery occlusion
Inability to apply bilateral sensors to patient's forehead

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To investigate whether increasing the inspired oxygen concentration improves cerebral oxygenation during the period of carotid cross-clamping in patients undergoing carotid endarterectomy (CEA) under regional anaesthesia.;Secondary Objective: ;Primary end point(s): Patient participation in the trial is concluded at the end of surgery when all readings have been obtained
Secondary Outcome Measures
NameTimeMethod
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