A New Oxygen Mask for Carotid Endarterectomy Under Local Anaesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01064908
First received: February 4, 2010
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 Intervention
Stroke
TIA
Surgery
Anaesthesia
Carotid Stenosis
Device: OxyMask

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brighton and Sussex University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carotid endarterectomy
Patients who are undergoing elective carotid endarterectomy under local anaesthesia
Device: OxyMask
Novel vortex oxygen delivery mask
Other Name: OxyMask Adult Large

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Vascular Surgical Outpatients, booked for CEA under local anaesthetic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064908

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

No publications provided

Responsible Party: Dr C. Mark Harper, Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01064908     History of Changes
Other Study ID Numbers: 09/181/HAR
Study First Received: February 4, 2010
Last Updated: August 7, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by 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
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014