BACKGROUND: The i-gel® Plus is a modified version of the i-gel® supraglottic airway device. It contains a wider drainage port; a longer tip; ramps inside the breathing channel; and an additional port for oxygen delivery. There has been no prospective evaluation of this device in clinical practice. METHODS: This international, multicentre, prospective cohort study aimed to evaluate the performance of the i-gel Plus in adult patients undergoing elective procedures under general anaesthesia. The primary outcome was overall insertion success rate, defined as the ability to provide effective airway management through the device from insertion until the end of the surgical procedure. Secondary outcomes included device performance and incidence of postoperative adverse events. Data from the first 1000 patients are reported. RESULTS: In total, 1012 patients were enrolled; 12 forms were excluded from the final analysis due to incomplete data leaving 1000 included patients (545 female). Overall insertion success rate was 98.6%, with a first-attempt success rate of insertion of 88.2%. A significant difference between females and males was seen for the overall success rate (97.4% vs. 99.6% respectively) but not for first-attempt successful insertion. Mean (SD) oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor that increased the risk of first-attempt failure was low operator experience. Complications included desaturation < 85% in 0.6%; traces of blood on the device in 7.4%; laryngospasm in 0.5%; and gastric contents inside the bowl in 0.2% of patients. CONCLUSIONS: The i-gel Plus appears to be an effective supraglottic airway device that is associated with a high insertion success rate and a reasonably low incidence of complications.

• MeSH
• celková anestezie MeSH
• design vybavení MeSH
• dospělí MeSH
• elektivní chirurgické výkony * MeSH
• intratracheální intubace * přístrojové vybavení   metody   MeSH
• kohortové studie MeSH
• laryngální masky * MeSH
• lidé středního věku MeSH
• lidé MeSH
• pooperační komplikace epidemiologie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• zajištění dýchacích cest přístrojové vybavení   metody   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH

Supraglotické pomůcky patří v současnosti do rutinní klinické praxe pro zajištění dýchacích cest u elektivních operačních výkonů, ale i k tracheální intubaci nebo oxygenaci při obtížném zajištění dýchacích cest. Dalšími indikacemi jsou použití v urgentní a intenzivní medicíně i v přednemocniční péči. Zvýšené požadavky na bezpečnost, rozšíření indikací a použití v akutních situacích vedly k vývoji nových pomůcek. Univerzální pomůcky typu Ambu AuraGain, LMA Protector nebo i‐‐gel Plus umožňují použití při elektivních operacích i pro následnou fibrooptickou tracheální intubaci. Další pomůcky jako LMA Guardian byly vyvinuty ke zvýšení těsnících tlaků, zatímco Baska maska má samoregulovatelný tlak v manžetě, který by měl teoreticky snížit četnost pooperačních komplikací. LMA Gastro byla vyvinuta pro endoskopické výkony na jícnu a žaludku, iLTS a TotalTrack VLM jako speciální pomůcky pro obtížné zajištění dýchacích cest.

Supraglottic airway devices currently belong to routine clinical practice for securing the airways in elective procedures, but also for tracheal intubation or oxygenation in difficult intubation scenarios. Other indications are airway management in emergency and intensive care medicine or pre-hospital care. Increased safety requirements, extended indications, and use in acute situations have led to the development of novel supraglottic airway devices. Universal devices such as Ambu Aura Gain, LMA Protector, or i-gel Plus allow use in elective surgery and subsequent fiberscope-guided tracheal intubation. Other devices such as the LMA Guardian have been developed in order to increase seal pressures, while the Baska mask has a self-regulating cuff pressure that should theoretically reduce the incidence of postoperative complications. LMA Gastro was developed for endoscopic procedures on the oesophagus and stomach, iLTS, and TotalTrack VLM as special aids for difficult airway management.

• Klíčová slova
• supraglotické pomůcky,
• MeSH
• intratracheální intubace přístrojové vybavení   MeSH
• lidé MeSH
• umělé dýchání přístrojové vybavení   MeSH
• zajištění dýchacích cest * přístrojové vybavení   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH

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