None listed
Conditions
Brief 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.
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 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 a
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.
Sponsors
Department of Anaesthesiology, Universiti Malaya
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult surgical patients above 18 years of age, undergoing surgery under general anaesthesia (appropriate to be done with a supraglottic airway device)
Exclusion criteria
ASA IV; morbidly obese BMI > 40kg/m2; high risk or regurgitation/aspiration e.g.: symptomatic gastro-oesophageal reflux, hiatus hernia; respiratory tract pathology e.g.: preoperative sore throat
Outcome results
None listed