A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064908
• Other study ID #: 09/181/HAR
• Status: Completed
• Phase: N/A
• First received: February 4, 2010
• Last updated: August 7, 2013
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anaesthesia
• Carotid Stenosis
• Stroke
• Surgery
• TIA

Intervention

Device:
• OxyMask
Novel vortex oxygen delivery mask

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	A further secondary outcome is to determine whether the mask is acceptable to patients, as recorded by a questionnaire.		Within 24 hours post-operatively	No