La Tunisie médicale
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La Tunisie médicale · Apr 2014
Clinical TrialEvaluation of a new supraglottic airway device in ambulatory surgery: the I-gel.
The I-gel® is a new single-use supraglottic airway device with a non-inflatable cuff. It is composed of a thermoplastic elastomer and a soft gel-like cuff that adapts to the hypopharyngeal anatomy. Its tube is profiled to facilitate and stabilize its insertion. aim : The aim of our study is to state the efficiency and the place of I-gel® in airway management in adult anaesthetic practice. methods: One hundred patients, ASA I-II, scheduled for shortduration elective surgery under general anaesthesia were included in this prospective study. Patients with neck pathology, previous or anticipated airway problems, increased risk of regurgitation or aspiration, ASA III and above and undergoing emergency surgery were not included in the study. We collected the following data: adequacy of the size recommended to the patient, ease in inserting the I-gel®, leak fraction, gastric leak, complications during insertion and removal, ease in inserting the gastric tube, haemodynamic and ventilatory parameters, stability during patient movement and satisfaction of the anaesthetists. results: The success rate of insertion and the use of the I-gel was respectively 99% and 96%. The device was inserted at the first attempt in 92% of cases. The introduction of the I-gel® was rated easy in 99% of cases taking a median of 13 seconds. Complications of insertion were restricted to coughing in 5 patients and hiccups in 7 patients. There were no significant increase in heart rate and mean arterial blood pressure compared to pre-insertion values. An audible leak was recorded in 14.6% of cases. The need for additional manoeuvres was less than or equal to 2 in 96.9 % of patients. The mean of the recorded peak airway pressure values was 18 cmH2O. After a fibreoptic exam via the airway tube, the glottis was completely seen in 74% of cases and partially seen in 14.6%. Two cases of gastric inflation were recorded. There was no case of regurgitation or hypoxemic episode during this trial. Post-operatively sore-throat was reported by one patient in recovery. After I-gel withdrawal, trace of blood was observed in 5 devices. One case of dental trauma was noted. 95% of the anaesthetists were satisfied with the use of the I-gel in their pratice. ⋯ This study showed that I-gel® can be used safely and effectively in patients undergoing short-duration elective surgery because the I-gel® has a very good insertion success rate and few complications. The fibreoptic position of the device was correct and the ventilation was highly effective. These elements must be corroborated in larger series.