None listed
Conditions
Brief summary
The overall aim of the project is to demonstrate the utility of the newly developed novel laryngeal mask airway (LMA) device called the LMAGastro (Trademark) which is a first for laryngeal mask airway (LMA) use in upper gastrointestinal endoscopy procedures. The device’s novel design features include firstly a dedicated endoscopic channel for entry into the oesophagus and secondly, a dedicated airway channel and cuff to protect the airway. The hypothesis is: the LMAGastro (Trademark) will have a high endoscopic success rate and provide a clinically satisfactory protected airway during upper gastrointestinal endoscopy procedures under anaesthesia. Gastroenterologists won’t change practice unless endoscopic success rates are very high. We are anticipating that the modified airway device (being developed with TELEFLEX and in collaboration with the Gastroenterology Department of the RHH) will not only provide reliable and superior upper gastro-intestinal access, but also provide airway protection and better anaesthesia monitoring of the patient, both significantly enhancing patient safety leading to a change in practice.
Interventions
After induction of anaesthesia with Propofol the LMA GASTRO (Trademark) is inserted into the upper airway with the patient’s head placed in the ‘sniffing’ position. The standardized method of insertion include lubricating the devise, before grasping it along the integral bite block and advancing into the mouth in the direction towards the hard palate whilst gliding downwards and backwards along the hard palate until definite resistance is felt. A maximum of three attempts by an anaesthetist is
After induction of anaesthesia with Propofol the LMA GASTRO (Trademark) is inserted into the upper airway with the patient’s head placed in the ‘sniffing’ position. The standardized method of insertion include lubricating the devise, before grasping it along the integral bite block and advancing into the mouth in the direction towards the hard palate whilst gliding downwards and backwards along the hard palate until definite resistance is felt. A maximum of three attempts by an anaesthetist is allowed before considered a failure of the laryngeal mask airway (LMA GASTRO Trademark). A breathing circuit is then connected to a dedicated channel for airway control This is followed by the insertion of an upper-gastrointestinal endoscope, through a separate dedicated channel in the LMA GASTRO (Trademark), directly into the oesophagus by a gastroenterologist. A maximum of three attempts to insert the upper-gastrointestinal endoscope is allowed before considered a failure.
Sponsors
Royal Hobart Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ASA I –II, older than 18 years of age, fasted at least 6 hours for solids and 2 hours for clear liquids, undergoing elective upper gastro-intestinal endoscopic procedures requiring deep sedation
Exclusion criteria
Patients at significant risk of pulmonary aspiration will be excluded based on anaesthetic clinical judgment after performing a clinical risk assessment. The clinical risk assessment will be performed based on patient history (focussing particularly on risk factors for aspiration) and physical examination to establish the risk of aspiration prior to enrolment. Possible risk factors for aspiration include: 1. Increased gastric content: delayed gastric emptying including lap band in situ, gastric hyper secretion, overfeeding, lack of fasting (less than six hours solids and two hours for clear fluid). 2. Increased tendency to regurgitate: symptomatic or uncontrolled gastro-oesophageal reflux, oesophageal strictures, Zenker Diverticulum, achalasia. 3. Laryngeal incompetence: Emergency surgery, head injuries, cerebral infarct, neuromuscular disorders (Parkinson’s disease, Gullian Barre), muscular dystrophies (cerebral palsy, cranial neuropathies)
Outcome results
None listed