Abstract
Study objective: The aim of the study was to determine if there is a clinically significant difference in the performance (Ease of insertion, manipulations, ventilator performance, leak pressures and complications) of two second generation supraglottic airways (LMA ProSeal® (Intavent Direct, UK) and the i-gel® (Intersurgical, Wokingham, UK) in non-paralysed European patient population group, during routine anaesthesia with spontaneous and controlled ventilation. Methods: Ninety-eight American Society Anaesthesiologists physical status class I-III patients, undergoing elective surgical procedures, judged suitable for general anaesthesia with a classic LMA were recruited for the trial. Patients were randomised to have either the LMA ProSeal® or the i-gel® group as the supraglottic airway for spontaneous and controlled ventilation during routine anaesthesia prior to induction. Measurements: The primary outcome was first attempt insertion success and time to insertion of either the LMA ProSeal® or i-gel®. Secondary outcomes were, ease of insertion, manipulations to establish patent airway, fibre optic view of larynx, complications during anaesthesia, emergence, recovery, and anaesthetist assessment of device performance. Results: First time insertion success rate was 86% in the LMA ProSeal® group and 78% in the i-gel® group (P=0.61). The number of insertion attempts did not differ between the two groups (P=0.31). The ease of insertion (P=0.64), time to establish a patent airway (P=0.06), number of manipulations (P=0.97) and anatomical positioning of the device (P=0.36) and ventilator performance were similar between the two groups. The number of patients reporting post-operative sequelae and the total number of complications were similar between devices in recovery (P=0.72) and at 24 hours (P=1.0). The leak pressure was significantly higher in the group LMA ProSeal® (28 cmH2O) compared to i-gel® (22 cmH2O) (P=0.002). Conclusion: The LMA ProSeal® and i-gel® have comparable performance characteristics during routine general anaesthesia in non-paralysed patients. The LMA ProSeal® has a higher airway seal that is statistically significantly different and may be clinically important.
Highlights
The LMA ProSeal® (Intavent Direct, Maidenhead, UK) is a reusable supraglottic airway device (SAD) with both an airway lumen and a drain tube
The i-gel® (Intersurgical, Wokingham, UK) is a single use SAD made of a medical grade thermoplastic elastomer
We studied American Society of Anaesthetists physical status 1-3 patients judged suitable for classic LMA® anaesthesia undergoing elective surgery in the supine or lithotomy position
Summary
The LMA ProSeal® (Intavent Direct, Maidenhead, UK) is a reusable supraglottic airway device (SAD) with both an airway lumen and a drain tube. It achieves high-pressure seals for both the airway and the oesophagus [1,2]. The i-gel® (Intersurgical, Wokingham, UK) is a single use SAD made of a medical grade thermoplastic elastomer It has a drain tube running alongside the airway tube. The i-gel® has a lower airway seal and oesophageal seal than the LMA ProSeal® [2,3] Both devices have design features intended to reduce the risk of aspiration of gastric contents and can be regarded as second generation SADs [5]
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