A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01064908
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : August 9, 2013
Information provided by (Responsible Party):
Dr C. Mark Harper, 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).

Condition or disease Intervention/treatment
Stroke TIA Surgery Anaesthesia Carotid Stenosis Device: OxyMask

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 Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Carotid endarterectomy
Patients who are undergoing elective carotid endarterectomy under local anaesthesia
Device: OxyMask
Novel vortex oxygen delivery mask
Other Name: OxyMask Adult Large

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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 ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Vascular Surgical Outpatients, booked for CEA under local anaesthetic

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01064908

United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
Principal Investigator: Mark Harper, MB BS Brighton and Sussex University Hospitals NHS Trust

Responsible Party: Dr C. Mark Harper, Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust Identifier: NCT01064908     History of Changes
Other Study ID Numbers: 09/181/HAR
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust:
Endarterectomy, Carotid
Carotid stenosis
Oxygen mask

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Depressants
Physiological Effects of Drugs