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Completed

NCT Number: NCT01064908

A New Oxygen Mask for 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).

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Key information

Conditions

Stroke Anaesthesia Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Surgery TIA Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Sussex County Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OxyMask

Device

Novel vortex oxygen delivery mask

Other names: OxyMask Adult Large

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2010
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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