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

February 4, 2010
August 7, 2013
January 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01064908 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Vascular Surgical Outpatients, booked for CEA under local anaesthetic

  • Stroke
  • TIA
  • Surgery
  • Anaesthesia
  • Carotid Stenosis
Device: OxyMask
Novel vortex oxygen delivery mask
Other Name: OxyMask Adult Large
Carotid endarterectomy
Patients who are undergoing elective carotid endarterectomy under local anaesthesia
Intervention: Device: OxyMask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01064908
09/181/HAR
No
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Not Provided
Principal Investigator: Mark Harper, MB BS Brighton and Sussex University Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP