An evaluation of the i-gel Plus supraglottic airway device in elective patients: the interim results from a prospective international multicentre study

The i-gel Plus supraglottic airway represents the next generation of the i-gel device. The aim of this international multicentre prospective cohort study was to evaluate its performance in adult patients during elective procedures in various surgical disciplines under general anaesthesia. The primary outcome of the study was the overall success rate of insertion allowing effective airway management, ventilation, and oxygenation. The secondary outcomes included perioperative performance of the device and the incidence of postoperative adverse events. The data of the first 1000 patients from our study (455 males and 545 females) are presented. These patients were mostly operated on in the supine position (83.3%) with a minority of them being in the lateral or lithotomy positions. The overall success rate was 98.6%, with a first-attempt success rate of insertion of 88.1%. A significant difference between males and females was seen for the overall success rate - 97.4% vs. 99.6% (p=0.002) but not for the successful insertion on the first attempt (p=0.97) The mean oropharyngeal seal pressure was 32 ({+/-}7) cmH2O. The only independent factor increasing the risk of first-attempt failure was low experience of the operator (p<0.001). The insertion of the device was rated by 80.3% as being either very easy or easy. Fibreoptic assessment through the i-gel Plus showed a full view of the vocal cords in 67.8% of patients, a partial view in 21.9% and a downfolded epiglottis in 9.4% of patients. A gastric tube was inserted in 11.2% of patients with a 99.1% success rate. Perioperative complications included desaturation below 85% in 0.6%, traces of blood on the device in 7.4%, laryngospasm in 0.5% and gastric contents inside the cuff in 0.2% of patients. There were no clinical signs of aspiration and a 0.1% incidence of bronchospasm. Severe postoperative sore throat was recorded in 1.4%, and long-term hoarse voice in 0.2% of patients. All patients with moderate and serious postoperative complaints are being followed up by phone at 3 and 6 months. The i-gel Plus seems to be an effective supraglottic airway device providing a high success rate of insertion, sufficient oropharyngeal seal pressure, and a reasonably low incidence of complications. Trial registrationISRCTN86233693