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.
- MeSH
- celková anestezie * škodlivé účinky MeSH
- dospělí MeSH
- intratracheální intubace metody MeSH
- kohortové studie MeSH
- laryngální masky * škodlivé účinky MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- prospektivní studie MeSH
- zajištění dýchacích cest metody MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Fibreoptic intubation through a supraglottic airway is an alternative plan for airway management in difficult or failed laryngoscopy. The aim of this study was to compare three supraglottic airways as conduits in patients with at least one predictor for difficult laryngoscopy. The i-gel was compared with the single-use intubating laryngeal mask airway (sILMA) and CTrach laryngeal mask in 120 adult patients scheduled for elective surgeries under general anaesthesia using a prospective, randomized and single-blinded design. Primary outcome was success rate of tracheal intubation through the device, while secondary outcomes were times required for device insertion and tracheal tube placement, fibreoptic scores and the incidence of perioperative complications and postoperative complaints. The success rates showed no statistical difference between devices (i-gel 100%, CTrach 97.5%, ILMA 95%). Insertion time was shortest for the i-gel (12.4 s) compared with ILMA (19.3 s) and CTrach (24.4 s). Intubation time was shorter in the i-gel group (29.4 s) in comparison with the CTrach (39.8 s, p<0.05) and sILMA (51.9 s, p<0.001) groups. Best fibreoptic scores were observed also in the i-gel group. In total, 24 patients (20%) presented with difficult laryngoscopy. The i-gel showed significantly shorter times for insertion and fibreoptic intubation than the other two devices in this group. No difference was observed in the incidence of postoperative complaints. The i-gel is a suitable alternative to the sILMA and CTrach for fibrescope-guided tracheal intubation. Shorter insertion and intubation times with the i-gel may provide advantage in case of difficult oxygenation.
- MeSH
- design vybavení MeSH
- dospělí MeSH
- intratracheální intubace přístrojové vybavení metody MeSH
- jednoduchá slepá metoda MeSH
- kardiopulmonální resuscitace přístrojové vybavení MeSH
- laryngální masky * MeSH
- laryngoskopie metody MeSH
- laryngoskopy MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- technologie optických vláken * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- Publikační typ
- abstrakt z konference MeSH