A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

A Study To Determine The Effectiveness Of A New Oxygen Mask At Increasing Arterial Oxygen Content During Carotid Endarterectomy Under Local Anaesthesia

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Anaesthesia; Carotid Stenosis; Surgery; TIA
• Intervention / Treatment: 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
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Royal Sussex County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Vascular Surgical Outpatients, booked for CEA under local anaesthetic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Investigators: Principal Investigator: Mark Harper, MB BS, Brighton and Sussex University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Carotid stenosis; Endarterectomy, Carotid; Oxygen mask
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: 09/181/HAR