Evaluation of the i-gel® Plus supraglottic airway device in elective surgery: a prospective international multicentre study.

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.

The i-gel Supraglottic Airway as a Conduit for Fibreoptic Tracheal Intubation - A Randomized Comparison with the Single-use Intubating Laryngeal Mask Airway and CTrach Laryngeal Mask in Patients with Predicted Difficult Laryngoscopy.

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.

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.

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.

Video Laryngoscopic Intubation Using the King VisionTM Laryngoscope in a Simulated Cervical Spine Trauma: A Comparison Between Non-Channeled and Channeled Disposable Blades.

Videolaryngoscopes may reduce cervical spine movement during tracheal intubation in patients with neck trauma. This manikin study aimed to compare the performance of disposable non-channeled and channeled blades of the King Vision™ videolaryngoscope in simulated cervical spine injury. Fifty-eight anesthesiologists in training intubated the TruMan manikin with the neck immobilized using each blade in a randomized order. The primary outcome was the time needed for tracheal intubation, secondary aims included total success rate, the time required for visualization of the larynx, number of attempts, view of the vocal cords, and subjective assessment of both methods. Intubation time with the channeled blade was shorter, with a median time of 13 s (IQR 9-19) vs. 23 s (14.5-37.5), p < 0.001, while times to visualization of the larynx were similar in both groups (p = 0.54). Success rates were similar in both groups, but intubation with the non-channeled blade required more attempts (1.52 vs. 1.05; p < 0.001). The participants scored the intubation features of the channeled blade significantly higher, while visualization features were scored similarly in both groups. Both blades of the King Vision™ videolaryngoscope are reliable intubation devices in a simulated cervical spine injury in a manikin model when inserted by non-experienced operators. The channeled blade allowed faster intubation of the trachea.