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 multicentre cohort study

IntroductionSupraglottic 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 analysisThis 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 disseminationThe 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 numberISRCTN86233693;Pre-results.

A comparative study on the perfomance between I-gel® and Classic laryngeal mask airway in anaesthetized spontaneously breathing patients

The classic Laryngeal Mask Airway (c-LMA) is a first generation supraglottic airway device with an inflatable cuff forming a low pressure seal around the laryngeal inlet and permitting ventilation. I-gel is a supraglottic airway device made of thermoplastic elastomer which is soft gel-like and transparent. Unlike the classic LMA(c-LMA), I-gel does not have an inflatable cuff. In view of this, the present study was undertaken to compare the performance of the two supraglottic airway devices in spontaneously breathing adult patients posted for elective surgeries under general anesthesia.To compare the ease of insertion, number of insertion attempts, time for insertion, airway leak pressure, hemodynamic changes as well as perioperative complications such as cough sore throat between patients using the two devices.Sixty patients admitted in SRM medical college and research center scheduled for various elective surgical procedures under general anesthesia belonging to ASA class I and II were included in the study. They were randomly divided into two groups of 30 each using a random number generator. In group I, I-gel supraglottic airway device was used and in Group 2 classic laryngeal mask airway was used. Data was collected using a questionair containing socio-demographic details, details regarding performance of the device as well as hemodynamic changes and perioperative complications.The insertion was easy in 25 patients (83.3%) in group I, while in group II 15 patients (50%) had easy insertion. P=0.0 1781. The mean time of insertion for I-gel was (20. 17± 3 .91 seconds) which was significantly shorter compared to c-LMA (26.80 ±7.24 seconds) (P<0.001).There was no statistically significant difference between the devices with respect to number of attempts of insertion. Even though the airway leak pressure is not statically significant, the mean oropharyngeal leak pressure for I-gel was 20.40±5.68 (mm Hg), which was higher than c-LMA 18.73±5.06 (mm Hg), which is well within the normal limits to prevent aspiration. There were no statistically significant differences in hemodynamic changes. No Blood staining was seen after removal of device in I-gel group where it was observed in 2 (7%) patients in c- LMA group. Post removal cough was more in c -LMA (13 .3%) than l-gel (P= 0.04 SS*). Pharyngo-Laryngeal morbidity was more with classic LMA. Sore throat was more with the classic LMA (13 .3%) when compared to I-gel group (3%).We conclude that I-gel is a better airway when compared to c-LMA with respect to ease of insertion, shorter duration for insertion, adequate oropharyngeal seal with lesser pharyngo-laryngeal morbidity and less incidence of airway trauma.

Comparison of fibre-optic-guided endotracheal intubation through a supraglottic airway device versus hyperangulated video laryngoscopy by emergency physicians: A randomised controlled study in cadavers

Background: After failed endotracheal intubation, using direct laryngoscopy, rescued using a supraglottic airway device, the choice of subsequent method to secure a definitive airway is not clearly determined. Objective: The aim of this study was to compare the time to intubation using a fibre-optic airway scope, to guide an endotracheal tube through the supraglottic airway device, with a more conventional approach using a hyperangulated video laryngoscope. Methods: A single-centre randomised controlled trial was undertaken. The population studied were emergency physicians working in an adult major trauma centre. The intervention was intubation through a supraglottic airway device guided by a fibre-optic airway scope. The comparison was intubation using a hyperangulated video laryngoscope. The primary outcome was time to intubation. The trial was registered with ANZCTR.org.au (ACTRN12621000018819). Results: Four emergency physicians completed intubations using both of the two airway devices on four cadavers for a total of 32 experiments. The mean time to intubation was 14.0 s (95% confidence interval = 11.1–16.8) in the hyperangulated video laryngoscope group compared with 29.2 s (95% confidence interval = 20.7–37.7) in the fibre-optic airway scope group; a difference of 15.2 s (95% confidence interval = 8.7–21.7, p < 0.001). All intubations were completed within 2 min, and there were no equipment failures or evidence of airway trauma. Conclusion: Successful intubation of the trachea without airway trauma by emergency physicians in cadavers is achievable by either fibre-optic airway scope via a supraglottic airway device or hyperangulated video laryngoscope. Hyperangulated video laryngoscope was statistically but arguably not clinically significantly faster than fibre-optic airway scope via supraglottic airway device.

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.

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 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 analysis: This 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 dissemination: The 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.

Intubating Through Supraglottic Airway Devices: A Narrative Review

Implication Statement: Despite the increasing popularity of video laryngoscopes, the supraglottic airway device (SAD) remains a critical airway rescue tool. The SAD provides a conduit for tracheal intubation in failed laryngoscopy. This article aims to help the operator: (1) select an intubating SAD with consistent performance; (2) inform the appropriate SAD-endotracheal tube pairings; and (3) explain various SAD and endotracheal tube maneuvers available to increase chances of successful intubation. Objectives: The first supraglottic airway device (SAD) was introduced more than thirty years ago. Since then, SADs have undergone multiple iterations and improvements. The SAD remains an airway rescue device for ventilation and an intubation conduit on difficult airway algorithms. Data Sources: Several SADs are specifically designed to facilitate tracheal intubation, i.e., “intubating SADs,” while most are “non-intubating SADs.” The two most commonly reported tracheal intubation methods via the SADs are the blind and visualized passage of the endotracheal tube (ETT) preloaded on a fiberoptic scope. Fiberoptic guided tracheal intubation (FOI) via an intubating SAD generally has higher success rates than blind intubations and is thus preferred. However, fiberscopes might not always be readily available, and anesthesiologists should be skilled to successfully intubate blindly through a SAD. Summery: This narrative review describes intubating SAD with consistent performance, appropriate SAD-ETT pairings, and various SAD and ETT maneuvers to increase successful intubation chances.