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A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

NCT ID: NCT01064908

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Stroke TIA Surgery Anaesthesia Carotid Stenosis

Keywords

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Endarterectomy, Carotid Carotid stenosis Oxygen mask

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Carotid endarterectomy

Patients who are undergoing elective carotid endarterectomy under local anaesthesia

OxyMask

Intervention Type DEVICE

Novel vortex oxygen delivery mask

Interventions

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OxyMask

Novel vortex oxygen delivery mask

Intervention Type DEVICE

Other Intervention Names

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OxyMask Adult Large

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr C. Mark Harper

Consultant Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Harper, MB BS

Role: PRINCIPAL_INVESTIGATOR

Brighton and Sussex University Hospitals NHS Trust

Locations

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Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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09/181/HAR

Identifier Type: -

Identifier Source: org_study_id