A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia
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|ClinicalTrials.gov Identifier: NCT01064908|
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment|
|Stroke TIA Surgery Anaesthesia Carotid Stenosis||Device: OxyMask|
Carotid endarterectomy (CEA) is a procedure to remove plaques from a carotid artery (one of the two main arteries supplying blood to the brain). The procedure is effective at reducing the risk of subsequent stroke. To access the artery, an incision is made in the artery wall which means that the artery must be clamped in order to prevent blood loss. Consequently, the blood supply (and therefore oxygen supply) to the brain is reduced. To ensure that the patient has sufficient oxygen to avoid brain damage, this procedure is often carried out under local anaesthetic as this means the anaesthetist can talk to them during the operation; by this means they can determine the patient's conscious level and whether or not they need supplementary oxygen.
There are various ways to administer the supplementary oxygen. Most oxygen masks completely cover the mouth and nose which inevitably limits patient-doctor communication. Oxygen is therefore usually administered via nasal tubes. However, the actual level of oxygen taken in by the patient is very hard to measure, and at best is only 40%.
A novel mask with an open design. By creating a 'vortex' of oxygen it can deliver higher concentrations of oxygen to the patient without significantly interfering with doctor-patient communication and, at the same time, improving patient comfort.
We wish to test the efficacy of this mask during CEA and plan to do this by measuring the oxygen content of blood directly using blood samples; we also monitor markers of brain damage which may occur from lack of oxygen. Finally, we will survey the patients as to acceptability of the mask.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||A Study To Determine The Effectiveness Of A New Oxygen Mask At Increasing Arterial Oxygen Content During Carotid Endarterectomy Under Local Anaesthesia|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Patients who are undergoing elective carotid endarterectomy under local anaesthesia
Novel vortex oxygen delivery mask
Other Name: OxyMask Adult Large
- The primary aim of this study the aim is to determine the effectiveness of the vortex oxygen mask in increasing blood oxygen levels during CEA in the awake patient during carotid clamping. [ Time Frame: 0 hours ]
- To determine whether or not increased cerebral oxygen levels are associated with reduced cerebral injury, as measured by biomarkers: neuron-specific enolase and S100B. [ Time Frame: 2.5 hours. ]
- A further secondary outcome is to determine whether the mask is acceptable to patients, as recorded by a questionnaire. [ Time Frame: Within 24 hours post-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064908
|Royal Sussex County Hospital|
|Brighton, East Sussex, United Kingdom, BN2 5BE|
|Principal Investigator:||Mark Harper, MB BS||Brighton and Sussex University Hospitals NHS Trust|