We have assessed the efficacy of a new laryngeal mask prototype, the intubating laryngeal mask airway (ILMA), as a ventilatory device and blind intubation guide. The ILMA consists of an anatomically curved, short, wide bore, stainless steel tube sheathed in silicone which is bonded to a laryngeal mask and a guiding handle. It has a single moveable aperture bar, a guiding ramp and can accommodate an 8 mm tracheal tube (TT). After induction of anaesthesia with propofol 2.5 mg kg-1 and fentanyl 2.5 micrograms kg-1, the device was inserted successfully at the first attempt in all 150 (100%) patients and adequate ventilation achieved in all, with minor adjustments required in four patients. Placement did not require movement of the head and neck or insertion of the fingers in the patient's mouth. Blind tracheal intubation using a straight silicone cuffed TT was attempted after administration of atracurium 0.5 mg kg-1. If resistance was felt during intubation, a sequence of adjusting manoeuvres was used based on the depth at which resistance occurred. Tracheal intubation was possible in 149 of 150 (99.3%) patients. In 75 (50%) patients no resistance was encountered and the trachea was intubated at the first attempt, 28 (19%) patients required one adjusting manoeuvre and 46 (31%) patients required 2-4 adjusting manoeuvres before intubation was successful. There were 13 patients with potential or known airway problems. The lungs of all of these patients were ventilated easily and the trachea intubated using the ILMA. In 10 of 13 (77%) of these patients, no resistance was encountered and the trachea was intubated at the first attempt; three of 13 (23%) patients required one adjusting manoeuvre. Tracheal intubation required significantly fewer adjusting manoeuvres in patients with a predicted or known difficult airway (P < 0.05). We conclude that the ILMA appeared on initial assessment to be an effective ventilatory device and intubation guide for routine and difficult airway patients not at risk of gastric aspiration.

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The standard laryngeal mask airway (LMA) functions both as a ventilatory device and as an aid to blind/fibrescopic-guided tracheal intubation. We describe the radiological and laboratory work used to bioengineer a new laryngeal mask prototype, the intubating laryngeal mask airway (ILMA). The aim was to create a new airway system with better intubation characteristics than the LMA. Other design goals were to eliminate the need for head-neck manipulation and insertion of fingers in the mouth during placement. Development was aided by analysis of magnetic resonance images of the human pharynx and laboratory testing with a variety of tracheal tubes. The principal features of this new system are an anatomically curved, rigid airway tube with an integral guiding handle, an epiglottic elevating bar replacing the mask bars, a guiding ramp built into the floor of the mask aperture and a modified silicone tracheal tube developed for use with the device.

A new prototype of the laryngeal mask airway (LMA), the intubating laryngeal mask airway (ILMA), was used to facilitate tracheal intubation in 100 fasted patients presenting for elective surgery. Alignment of the ILMA with the larynx was assessed fibreoptically before intubation without the investigator performing the intubation being aware of the view score. Ease of intubation correlated with the view obtained and with the degree of manipulation of the ILMA needed to achieve tracheal intubation. Intubation was successful in 93 patients. Of the seven intubation failures, five occurred in the first 20 patients. Conventional connection to the breathing system and ventilation of the lungs of the patients were possible throughout the intubation procedure.

SummaryFaced with the concern that an increasing number of airway management devices were being introduced into clinical practice with little or no prior evidence of their clinical efficacy or safety, the Difficult Airway Society formed a working party (Airway Device Evaluation Project Team) to establish a process by which the airway management community within the profession could itself lead a process of formal device/equipment evaluation. Although there are several national and international regulations governing which products can come on to the market and be legitimately sold, there has hitherto been no formal professional guidance relating to how products should be selected (i.e. purchased). The Airway Device Evaluation Project Team’s first task was to formulate such advice, emphasising evidence‐based principles. Team discussions led to a definition of the minimum level of evidence needed to make a pragmatic decision about the purchase or selection of an airway device. The Team concluded that this definition should form the basis of a professional standard, guiding those with responsibility for selecting airway devices. We describe how widespread adoption of this professional standard can act as a driver to create an infrastructure in which the required evidence can be obtained. Essential elements are that: (i) the Difficult Airway Society facilitates a coherent national network of research‐active units; and (ii) individual anaesthetists in hospital trusts play a more active role in local purchasing decisions, applying the relevant evidence and communicating their purchasing decisions to the Difficult Airway Society.