Surgical Tourniquets and Cerebral Emboli

  • Research type

    Research Study

  • Full title

    Surgical Tourniquets and Cerebral Emboli Pilot Study

  • IRAS ID

    163862

  • Contact name

    Andrew Sprowson

  • Contact email

    a.p.sprowson@warwick.ac.uk

  • Sponsor organisation

    University Hospital Coventry & Warwickshire NHS Trust

  • Clinicaltrials.gov Identifier

    NCT02240732

  • Duration of Study in the UK

    0 years, 2 months, 1 days

  • Research summary

    Traditionally knee surgeons throughout England use a surgical tourniquet during a total knee replacement operation. A surgical tourniquet is a device which is wrapped around the leg and squeezes the thigh when inflated, reducing the amount of blood at the knee. This provides a bloodless field and may improve cement fixation of the implant to bone. There is strong evidence to show that the risk of deep vein thrombosis (DVT) increases following tourniquet use and as a result some surgeons do not routinely use a tourniquet. Previous literature has suggested that embolism (blood clots) to the pulmonary circulation occurs frequently following the use of a tourniquet.

    Currently evidence as to whether emboli travel to the brain as well is limited. The aim of this observational pilot study is assess whether emboli secondary to the use of the tourniquet travel into the brain. We aim to observe whether emboli occur during a total knee replacement in surgeons who use a tourniquet versus those who do not. We aim to achieve this through non-invasive imaging: MR brain scans pre and post operatively, as well as transcranial doppler (TCD) ultrasound monitoring intra-operatively. The TCD scan is currently routinely used in the NHS by other specialties to measure emboli. The use of these imaging modalities will help to identify the presence and deposition of emboli in the brain which may lead to post-operative confusion during the normal total knee replacement. In addition, we will ask patients a short questionnaire of cognitive questions to assess whether brain function has been impaired post surgery. The questionnaire is known as a mini-mental state examination and is currently used in NHS practice to assess cognitive function. On the basis of this pilot study, the need for a larger randomized control trial will be assessed.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    14/YH/1214

  • Date of REC Opinion

    7 Oct 2014

  • REC opinion

    Favourable Opinion