NICE today (17 July) publishes guidance supporting the NHS using a device to help health professionals keep patients' airways open when unexpected problems occur during procedures.

This positive medical technology guidance advises that the Ambu aScope2 can help health professionals when there are unexpected difficulties in positioning a temporary tube to keep the airway open, and emergency action is needed to maintain the airway. An example of a procedure where endotracheal intubation (placing a tube in the windpipe to help breathing) may be needed is when a general anaesthetic is given.

The Ambu aScope2 is a thin, single-use, flexible endoscope (with an accompanying monitor) that uses video camera technology to help health professionals see the windpipe clearly, so that the breathing tube can be correctly placed when intubating patients with difficult airways. There could be unexpected difficulties when intubating any patient. Conditions which increase the risk include where the patient is obese, has limited mouth opening or cervical spine movements, has experienced trauma to the face or neck, has respiratory tract infections or cancers. The Ambu aScope2 may also be used to replace dislodged tracheostomies; a surgical procedure where an opening has been created through the neck at the front of the windpipe and a tube connected to an oxygen supply can be inserted to help with breathing.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are pleased to publish this new guidance on use of the Ambu aScope2 to help where emergency action is unexpectedly needed to keep a patient's airway open. There are an estimated 22,000 instances each year in the UK where there are unexpected difficulties with endotracheal intubation in patients. In some cases, this can result in patients being brain-damaged or dying because unexpected problems with keeping the airway open has left the patient starved of oxygen. This guidance can help clinical units fill a current gap in provision, and make sure that this effective device is available at the point of need in an emergency.

“The device supported in this new NICE guidance is an important step forward in patient safety, providing a potentially lifesaving option when unexpected difficulties do occur. Theindependent Medical Technologies Advisory Committee concluded that there was evidence to support using the Ambu aScope2 in people with unexpected difficult airways needing emergency intubation. The evidence considered indicates that the Ambu aScope2 is an acceptable alternative, where a multiple-use fibre optic endoscope is unavailable.

“The Committee considered that making the Ambu aScope2 available for use in typical clinical settings is likely to improve outcomes and improve patient safety, as well as noting advantages during replacement of dislodged tracheostomy tubes in the intensive care setting. The Committee also accepted that, based on cost modelling, the device is likely to save costs across a range of clinical settings and circumstances.”

Based on the evidence considered, the guidance concludes that the Ambu aScope2 is an acceptable alternative, when the current gold standard device used for managing difficult intubation - a multiple-use fibre optic endoscope (a thin flexible camera) - is unavailable. The evidence suggests that using the Ambu aScope2 is supported by cost models for a range of clinical settings, where there is no access to a multiple-use endoscope, or one is unavailable. Those settings are isolated units, operating theatre units, and intensive care units. The amount of money saved will depend on the number of intubations performed and on the number (if any) of existing multiple-use fibre optic endoscopes in use. As an example, the economic models indicate that savings could be highest when using the Ambu aScope2 in the intensive care setting, with estimated savings of around £3000 per unit each year in specific circumstances.

ENDS

Notes to Editors

About the NICE guidance

1. The medical technologies guidance, “Ambu aScope2 for use in unexpected difficult airways”, is available from 17 July 2013.

2. The Ambu aScope2 is manufactured by Ambu Ltd. Ambu Ltd is also the sponsor for this evaluation.

3. The Ambu aScope2 system is a portable device consisting of 2 components: a single‑use aScope (endoscope) and an accompanying aScope monitor for displaying the images. The manufacturer claims that the benefits of using the device include improved outcomes in emergencies and unexpected scenarios of difficult airway management due to the immediate availability of a sterile fibre optic endoscope that does not need calibration, a reduced risk of cross-infection from contaminated multiple-use fibre optic endoscopes, and improved safety for patients with tracheostomies.

4. The details of the cost modelling, and estimated savings depend on clinical setting. There are likely to be savings in the clinical settings considered, although there were some uncertainties in parameters used in the cost modelling. The clinical area where savings could be highest is likely to be using the Ambu aScope2 in the intensive care setting, which is estimated to save £3128 per year when more than 700 intubations are conducted each year, when there are 2 or fewer existing multiple-use fibre optic endoscopes, and assuming that 5% of intubations are difficult.

5. The cost of the Ambu aScope2 stated in the sponsor's submission is £179 (including VAT) per single-use endoscope. The monitor has a list price of £799 but is currently provided to NHS organisations free of charge with 5 Ambu aScope2 devices.

6. The current gold standard for managing difficult intubation is placement of an endotracheal tube (a breathing tube within the windpipe) guided by a multiple-use fibre optic endoscope. Using a fibre optic endoscope or a video scope allows the vocal chords to be seen followed by accurate placement of an endotracheal tube.

7. During the production of this guidance, NICE became aware of the development of the Ambu aScope3 product which is described in the implementation products supporting the guidance. The implementation products are available.

About the Medical Technologies Evaluation Programme

8. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available

About NICE

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