None listed
Conditions
Brief summary
Supraglottic airway devices are useful in situations where the expected time of surgery & general anaesthesia is short & are effective yet easy to insert. The AuraGain resembles the LMA Supreme in terms of anatomical curvature & availability of gastric access; and also allows passage of a tracheal tube which is not possible in a LMA Supreme, thus increasing its utility as a disposable supraglottic device with added functionality. The AMBU AuraGain may be useful as an alternative to the LMA Supreme as a disposable supraglottic device, and coupled with its intubating capability, may be suitable as a rescue device in a difficult airway situation. The study's null hypothesis is the the AuraGain is as efficacious and the LMA Supreme in paralysed patients receiving controlled ventilation. We aim to recruit and randomise 118 patients between 21-80 years old, of ASA status I to III to receive either the AuraGain or the LMA Supreme during general anaesthesia with controlled ventilation for laparoscopic procedures. The primary outcome of the study is oropharyngeal leak pressure, and secondary outcomes include success of device insertion, time to successful device placement, leak volume, peak inspiratory pressure and complications. Risks to participants are related that of general anaesthesia and LMA insertion, such as dental trauma, post-operative nausea and vomiting and sorethroat. Such side effects are very mild in severity and of short duration (less than 1 day). Rare adverse effects include regurgitation and aspiration. Upon completion, the study investigators can better advise local institutions if the AMBU AuraGain can be considered as an alternative airway device, especially for controlled ventilation. If the AuraGain (AMBU, Singapore) is shown to be similar or better in efficacy over the LMA Supreme, it may be useful as an alternative to the LMA Supreme in laparoscopic surgeries, with the added advantage of use as a rescue device in a difficult airway situation allowing direct intubation through the AuraGain via a flexible scope
Interventions
Use of the AMBU AuraGain laryngeal mask in patients undergoing laparoscopic surgery under general anaesthesia
The AMBU AuraGain laryngeal mask is a new phthalate-free, laryngeal mask device launched in June 2014. Both devices are similar in their fundamental design ie. anatomically curved airway tube, single-use disposable product, with a built-in gastric access port where an orogastric catheter can be inserted to suck out gastric contents and secretions, thereby enhancing patient safety when t
Use of the AMBU AuraGain laryngeal mask in patients undergoing laparoscopic surgery under general anaesthesia The AMBU AuraGain laryngeal mask is a new phthalate-free, laryngeal mask device launched in June 2014. Both devices are similar in their fundamental design ie. anatomically curved airway tube, single-use disposable product, with a built-in gastric access port where an orogastric catheter can be inserted to suck out gastric contents and secretions, thereby enhancing patient safety when they undergo positive pressure ventilation. Laryngeal mask airways are inserted routinely for short surgeries as a means to maintain a patent airway to allow the patient to remain ventilated and oxygenated by an anaesthetic ventilator during surgery. Insertion of device will be performed by 1 specialist anaesthetists (Principal Investigators) and 2 senior anaesthesia residents with at least 3 years experience, and at least 10 LMA Supreme & 10 AuraGain insertions in patients with normal airways before trial commencement; supervised by the Principal Investigator. A maximum of 3 attempts at insertion of the laryngeal mask device is allowed.
Sponsors
Tan Tock Seng Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists (ASA) physical status Class I-III 2. between age 21 to 80, 3. who require general anaesthesia for laparoscopic surgeries eg. cholecystectomy, inguinal herniorraphy..
Exclusion criteria
1. Patients of age less than 21 or more than 80 years old, 2. BMI more than 35 kg/m2 or body weight less than 30kg, 3. patients with a predicted difficult airway (based on history of difficult airway, inter-incisor distance less than 20mm, cervical spine pathology, modified Mallampati class 4, thyromental distance less than 60mm), 4. where laryngeal mask devices are contraindicated: high risk of regurgitation or aspiration (GERD, hiatus hernia), respiratory tract pathology e.g. restrictive lung disease/active upper respiratory tract infection, 5. patients who decline to participate in the study or are unable to give informed consent.
Outcome results
None listed