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: a protocol for a prospective multi-center cohort study
Authors: Klementova Olga , Bhoday Taranpreet Kaur , Werner Jakub , Lopez Ana M. , Donaldson Will , Lichnovsky Erik , Gaszynski Tomasz , Henlin Tomas , Bruthans Jan , Ulrichova Jitka , Lukes Martin , Blaha Jan , Kral Michal , Gomez Lidia , Berge Raquel , Holland Jonathan , McAleavey Francis , Arava Shiva , Skripecka Lubica Merjava , Sobczyk Sebastian , Tyll Tomas , Michalek Pavel 
Published: July 2021

ABSTRACTIntroductionSupraglottic 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 minimalization 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 trial 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 analysisThis is a multicenter, prospective, interventional cohort study. The enrolment will take place in seven centers 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 disseminationThe trial 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 numberISRCTN86233693ARTICLE SUMMARYStrengths and limitations of this study-The study will provide the first data about the use of the novel supraglottic airway device, the i-gel Plus for maintaining ventilation and oxygenation during anaesthesia.-Broad inclusion criteria and the multicenter, multinational design of the study will allow study of a wide spectrum of populations of different age, gender and ethnicity and thus provide more generalisable results.-Patients showing significant postoperative adverse effects will be followed up for up to 6 months which will provide information about the long-term complication rates of the device.-The main limitation of the study is that the device will be trialled only in selected elective procedures and not as a rescue device or in difficult airway management scenarios.