INTRODUCTION: Supraglottic airway devices represent a less invasive method of airway management than tracheal intubation during general anaesthesia. Their continued development is focused mainly on improvements in the insertion success rate and minimalisation of perioperative and postoperative complications. The i-gel Plus is a novel, anatomically preshaped supraglottic airway device which achieves a perilaryngeal seal due to a non-inflatable cuff made of a soft thermoplastic elastomer. The purpose of this cohort study is to assess the success rate of the i-gel Plus use during elective procedures under general anaesthesia, its intraoperative performance, and the degree of postoperative complications. METHODS AND ANALYSIS: This is a multicentre, prospective, interventional cohort study. The enrolment will take place in seven centres in four European countries. We plan to enrol 2000 adult patients in total, who are scheduled for elective surgery under general anaesthesia, and with an indication for use of a supraglottic airway device for management of their airway. The study is projected to run over a period of 18 months. The primary outcome of the study is the total success rate of the i-gel Plus insertion in terms of successful ventilation and oxygenation through the device. Secondary outcomes include perioperative parameters, such as insertion time, seal/leak pressures, number of insertion attempts and postoperative adverse events and complications. Postoperative follow-up will be performed at 1 hour, 24 hours in all patients, and for selected patients at 3 and 6 months. ETHICS AND DISSEMINATION: The cohort study has received the following ethical approvals: General University Hospital Prague, University Hospital Olomouc, University Military Hospital Prague, University Hospital Barcelona, University Hospital Lodz, Antrim Area Hospital, Craigavon Area Hospital, Office for Research Ethics Committees Northern Ireland. The results will be published in peer-reviewed journals and presented at relevant anaesthesia conferences. TRIAL REGISTRATION NUMBER: ISRCTN86233693;Pre-results.

• Keywords
• adult anaesthesia, adult surgery, anaesthesia in orthopaedics, anaesthesia in urology,
• MeSH
• Anesthesia, General * adverse effects   MeSH
• Adult MeSH
• Intubation, Intratracheal methods   MeSH
• Cohort Studies MeSH
• Laryngeal Masks * adverse effects   MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Prospective Studies MeSH
• Airway Management methods   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

Supraglottic airway devices are routinely used for airway maintenance in elective surgical procedures where aspiration is not a significant risk and also as rescue devices in difficult airway management. Some devices now have features mitigating risk of aspiration, such as drain tubes or compartments to manage regurgitated content. Despite this, the use of these device may be associated with various complications including aspiration. This review highlights the types and incidence of these complications. They include regurgitation and aspiration of gastric contents, compression of vascular structures, trauma, and nerve injury. The incidence of such complications is quite low, but as some carry with them a significant degree of morbidity the need to follow manufacturers' advice is underlined. The incidence of gastric content aspiration associated with the devices is estimated to be as low as 0.02% with perioperative regurgitation being significantly higher but underreported. Other serious, but extremely rare, complications include pharyngeal rupture, pneumomediastinum, mediastinitis, or arytenoid dislocation. Mild short-lasting adverse effects of the devices have significantly higher incidence than serious complications and involve postoperative sore throat, dysphagia, pain on swallowing, or hoarseness. Devices may have deleterious effect on cervical mucosa or vasculature depending on their cuff volume and pressure.

• MeSH
• Elective Surgical Procedures MeSH
• Airway Extubation adverse effects   instrumentation   MeSH
• Pharyngitis pathology   MeSH
• Pharynx pathology   surgery   MeSH
• Humans MeSH
• Perioperative Period MeSH
• Postoperative Complications physiopathology   MeSH
• Deglutition Disorders pathology   therapy   MeSH
• Airway Management * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH