RecruitingACTRN12614001290684

Ambu AuraGain versus LMA Supreme Second Seal: oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients

Ambu AuraGain versus LMA Supreme Second Seal: comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients under general anaesthesia

Sponsor

Department of Anaesthesiology, Universiti Malaya

Enrollment

100 participants

Start Date

Nov 11, 2014

Study Type

Interventional

Conditions

Supraglottic device use in spontaneously breathing patients under general anaesthesia

Summary

The supraglottic airway device may substitute the invasive procedure of endotracheal intubation in selected patients/surgeries under general anaesthesia. The Ambu AuraGain is a new phthalate-free, anatomically curved, single use supraglottic airway device launced in June 2014. It features an intergrated gastric access port. We would like to compare the Ambu Auragain with the Lanyngeal Mask Airway Supreme (Second Seal), in terms of oropharyngeal leak pressure, ease of insertion, gastric drain functionality and haemodynamic response.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two airway devices used during surgery — the Ambu AuraGain and the LMA Supreme — to see which one works better when patients need anaesthesia. Both are breathing aids placed in the throat that avoid the need for a tube down the windpipe. Researchers want to compare how easily they can be inserted, how well they seal the airway, and whether they allow access to the stomach for safety. This helps improve the choice of airway device for different patients. You may be eligible if: - You are 18 years or older - You are having surgery under general anaesthesia that is suitable to be done with one of these airway devices You may NOT be eligible if: - You are rated ASA IV (very high-risk medical conditions) - Your BMI is above 40 (morbidly obese) - You have symptoms of acid reflux or a hiatus hernia (high risk of stomach contents coming up during anaesthesia) - You have a respiratory tract condition such as a sore throat before your surgery Talk to your doctor about whether this trial might be right for you.

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Interventions

Insertion of Ambu Auragain supraglottic device by an experienced anaesthesiologist (>10 year working experience). The Ambu Auragain differs from the LMA Supreme (control device) in which it has the

Insertion of Ambu Auragain supraglottic device by an experienced anaesthesiologist (>10 year working experience). The Ambu Auragain differs from the LMA Supreme (control device) in which it has the added feature of intubation capability. After the placement of the Ambu Auragain, it can be used as a conduit for direct endotracheal intubation assisted by a flexible scope. Patient is not premedicated. He/she will be positioned supine, and pre-oxygenated for 3 minutes. Standardised induction of anaesthesia with intravenous fentanyl 1-2 mcg/kg and propofol 2-3mg/kg. Ambu Auragain will be inserted when the patient's jaw is sufficiently slack. The duration of an insertion attempt is no longer than 120 seconds. The appearance of the first square end-tidal CO2 trace denotes successful establishment of effective ventilation. Otherwise, the device will be completely removed for another insertion attempt. (up to 3 attempts allowed) Once in place, the Ambu Auragain will be secured with surgical tape. A prelubricated 14 French gauge gastric tube will then be inserted into the gastric drain outlet, and ease & time taken for insertion will be assessed. Gastric decompression will be done and total amount of gastric fluid aspirated to be recorded. Oropharyngeal leak pressure will be measured after closing the adjustable pressure limiting valve with a fresh gas flow of 3 L/min, noting the airway pressure at equilibrium or when there is audible air leak from the throat. Maximum pressure allowed is 40 cm H2O. The patient's heart rate and blood pressure will be recorded every minute for the first 5 minutes from induction of anaesthesia. Anaesthesia will be maintained with sevoflurane 1-2 MAC. Upon end of the surgery, the Ambu Auragain will be removed (upon return of spontaneous breathing & eye opening) 45 minutes later, a blinded, independent observer will assess the patient for post operative sore throat, dysphonia and dysphagia.

Locations(1)

Kuala Lumpur, Malaysia

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ACTRN12614001290684