A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

Completed

• Conditions: TIA; Surgery; Anaesthesia; Carotid Stenosis; Stroke
• Interventions: Device: OxyMask

• Registration Number: NCT01064908
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust

Brief Summary

The purpose of this study is to determine the effectiveness of oxygenation and patient-acceptability of a novel oxygen face mask in patients undergoing carotid endarterectomies (CEAs).

Detailed Description

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Male or female
• Booked for carotid endarterectomy under local anaesthetic
• Competent to consent to inclusion

Exclusion Criteria

• Patient refusal and inability to provide consent
• Patients who are unable to understand instruction or communicate effectively
• Aged below 16 years
• Decreased conscious level during the period of study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy	OxyMask	Patients who are undergoing elective carotid endarterectomy under local anaesthesia

Primary Outcome Measures

Name	Time	Method
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.	0 hours

Secondary Outcome Measures

Name	Time	Method
To determine whether or not increased cerebral oxygen levels are associated with reduced cerebral injury, as measured by biomarkers: neuron-specific enolase and S100B.	2.5 hours.
A further secondary outcome is to determine whether the mask is acceptable to patients, as recorded by a questionnaire.	Within 24 hours post-operatively

Trial Locations

Locations (1)

Royal Sussex County Hospital; 🇬🇧 Brighton, East Sussex, United Kingdom