A “failed attempt” was defined as removal of the device from the mouth before re-insertion. The number of attempts required for insertion was recorded. If ventilation was deemed inadequate, the following manipulations were allowed: gentle pushing or pulling the device, chin lift, jaw thrust, head extension, or neck flexion. For the safety reason of the patients before the insertion of any of the devices after loss of verbal contact, the anesthetist checked that hand-ventilation with a facemask was possible.Īdequate placement of the airway device was assessed by gentle squeezing the reservoir bag and observing the end-tidal CO 2 waveform and movement of the chest wall. If coughing, gagging, or body movement occurred during insertion of device, propofol 1 mg/kg was added to achieve an adequate level of anesthesia. Induction of anesthesia was done by propofol titrated to loss of verbal contact with the patient, loss of eyelash reflex and relaxation of jaw. Both the groups received intra-venous injection midazolam 0.02 mg/kg, glycopyrrolate 0.2 mg and fentanyl 2 mcg/kg as premedication. All the patients in both the groups were pre-medicated with oral Midazolam 7.5 mg one hour prior to induction of anesthesia. The induction procedures were explained to them and informed consent was taken. All elective patients as per the study protocol were enrolled. All patients with co-exiting disease were excluded from the study. The insertions were performed by a single user who had experience of more than 1000 insertions of cLMA and at least 20 insertions for the i-gel.Ī thorough pre anesthetic evaluation was done a day before the procedure. Randomization was performed by an envelop method. Patients were allocated randomly into one of the two groups using sequentially numbered sealed opaque envelop naming the airway device to be evaluated first, group I i-gel group and group II cLMA group. In this crossover trial, both airways were inserted in each patient in random order. Both the devices were soaked with normal saline before use. For the cLMA size 3 was used when the patients’ weight was 90 kgs. The size of device used was decided by the anaesthetists based on the patient's bodyweight and manufactures’ recommendation. The significance level was set at 0.05.Īll the patients underwent pre-operative fasting according to the hospital guideline. Data were entered and statistical analysis was performed using SPSS software (version 16, SPSS Inc., Chicago, IL, USA). With a type I error 0.05 and power of 80% we calculated that the sample size required was at least 21 in each group, based on a parallel group design. Growing concern over the ability to clean reusable devices effectively led to the increase in the use of single-use devices.Īfter obtaining the Institutional Ethical committee's approval, 48 adults attending hospital during March 2009 till December 2010 were enrolled constituting both sexes, ASA-I and ASA-II, aged 16-50 years, weighing 35-75 kgs undergoing various surgical procedures like release of post burn contracture, debridement, split skin graft (SSG) and change of dressing for post burn neck contracture in whom laryngeal mask airway was considered appropriate. The cLMA has been widely used as a routine airway for elective surgery and during cardiopulmonary resuscitation. An integrated gastric channel can provide early indication of regurgitation, facilitating venting of gas from the stomach and allows for passage of nasogastric tube to empty the stomach contents. This houses a standard airway and separate gastric channel. The buccal cavity stabilizer has a widened, elliptical, symmetrical and laterally flattened cross sectional shape (but still round airway channel), providing good vertical stability and axial strength upon insertion. A supraglottic airway without an inflatable cuff has several potential advantages including easier insertion, minimal risk of tissue compression and stability after insertion. It creates a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. I-gel airway is a novel and innovative supraglottic airway management device made up of a medical grade thermoplastic elastomer which is soft, gel like and transparent.
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