A prospective evaluation of the i-gel Plus supraglottic airway device

  • Research type

    Research Study

  • Full title

    The evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia

  • IRAS ID

    278410

  • Contact name

    Will Donaldson

  • Contact email

    William.Donaldson@northerntrust.hscni.net

  • Sponsor organisation

    General University Hospital, Prague

  • ISRCTN Number

    ISRCTN86233693

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    The research project is an evaluation of the I-gel Plus Supraglottic Airway. Device (SAD). The I-gel plus SAD is a new iteration of the I-gel SAD with some changes to the device that may improve efficacy and safety. SADs are routinely used during anaesthesia to maintain and protect a patent airway. The study will evaluate this device in terms of ease of use, safety and postoperative profile. The study will take place in 6 centres, all in Europe, two of which are in Northern Ireland. Recruitment will be of 6000 healthy patients between the ages of 18-89 and the study will exclude patients with risk factors that make use of such a device unadvisable. Duration of the study is expected to be less than one year.

  • REC name

    HSC REC B

  • REC reference

    20/NI/0140

  • Date of REC Opinion

    27 Nov 2020

  • REC opinion

    Further Information Favourable Opinion