Randomized clinical trial of the i-gel™ and Magill tracheal tube or single-use ILMA™ and ILMA™ tracheal tube for blind intubation in anaesthetized patients with a predicted difficult airway

Abstract

The single-use supraglottic airway device i-gel™ has been described in several case reports as a conduit for intubation, but no prospective data about success rates of blind intubation are available. Therefore, we performed this prospective randomized controlled trial to compare the success rate of blind tracheal intubation with a Magill PVC tube through the i-gel™ with intubation using an sILMA™ PVC tube through the single-use intubating laryngeal mask airway (sILMA™). With ethics committee approval and written informed consent, 80 patients with predictors of a difficult airway were computer randomized to either supraglottic airway device (SAD). The corresponding tracheal tube (TT) was introduced through the SAD under fibreoptic visualization but without fibreoptic guidance. Primary outcome was blind intubation success rate. Times, airway leak pressure, fibreoptic view, and adverse events were recorded. To control for the influence of the TT, we compared data from 40 patients described in an accompanying study (sILMA™ with Magill TT and i-gel™ with sILMA™ TT). Blind intubation success rate through the sILMA™ (69%) was higher than with the i-gel™ (15%, P<0.001). Data from the other patient group excluded the TT type as the primary cause for the difference in success rate. Removal of SADs was without problems with no difference between the type of SAD. Blind tracheal intubation using the sILMA™ tube through the sILMA™ is much more successful than blind intubation with a Magill PVC tube through the i-gel™. Because of its low success rate, we would not recommend blind intubation through the i-gel™.