Novel ET tubes in Human volunteers

  • Research type

    Research Study

  • Full title

    First in Man Evaluation of an Optical Sensor Equipped Novel Endotracheal Tube. The Moss ETT

  • IRAS ID

    197567

  • Contact name

    Andrew Norris

  • Contact email

    anorris@nhs.net

  • Sponsor organisation

    Nottingham University Hospitals NHS Trust

  • Duration of Study in the UK

    0 years, 3 months, 31 days

  • Research summary

    Invasive ventilation via a tracheal tube is integral to critical care. However, the pressure exerted by inflatable cuffs on the tracheal wall can cause
    ulceration and scarring of the trachea. In patients ventilated for more than
    10 days, ~15% develop tracheal stenosis. Endotracheal/tracheostomy tubes are
    responsible for ~85% of acquired tracheal stenosis.

    Modern “high volume, low pressure cuffs” have helped to reduce injury, but
    the excess material in these large cuffs results in folding when
    incompletely inflated. These folds create channels, through which infected
    secretions can travel from the mouth and pharynx, past the cuff, into the
    lungs, causing Ventilator Associated Pneumonia (VAP). VAP occurs in
    ~20% of ventilated patients, increases length of stay by ~6 days, adding to
    care costs (>$1.2bn p.a. in US), and increasing mortality up to 50%.

    We aim to develop an endotracheal tube incorporating optical and
    pressure monitoring with a "low volume, appropriate-pressure cuff". Optical
    monitoring of tracheal microcirculation and cuff pressure monitoring will
    reduce injury by allowing contact pressure to be adjusted for individual
    patients, and allowing a low volume cuff to be used. Low volume cuffs are
    known to create a better seal.

    Our team has extensive experience in the application of optical
    technologies to healthcare. We have successfully demonstrated that we
    can identify pressure-related changes in blood flow in the mucosa.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    16/EE/0473

  • Date of REC Opinion

    10 Mar 2017

  • REC opinion

    Further Information Favourable Opinion