NICE guidance issued on single-use scope

More than 20 members of the Medical Technologies Advisory Committee of NICE – including doctors, professors, health economists and patient representatives – have taken part in reviewing evidence to support the use of a disposable intubation scope. 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. The draft NICE guidance supports the case for adopting the Ambu aScope2 for use in people with unexpected difficult airways needing emergency intubation. The evidence considered indicates that the device is an acceptable alternative, when a multiple-use fibre optic endoscope (a thin flexible camera) is unavailable. The multiple-use endoscope is the current gold standard device for managing difficult intubation. An example of a procedure where endotracheal intubation may be needed is when a general anaesthetic is given. 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 inserted to help with breathing. The system is a portable device consisting of two 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. 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. An External Assessment Centre report (which can be downloaded via the NICE website), stated that the cost of Ambu aScope2 was £179 per single-use scope, and the estimated mean cost of a reusable scope from NHS survey was £209 per patient/treatment. The incremental mean cost per patient for Ambu aScope in unexpected difficult intubation in the operating theatre was £68 less than for a reusable scope; for unexpected difficult intubation in ICU it was £130 less; and for dislodged tracheostomy it was £1,556 less. The clinical evidence for Ambu aScope2 was based on 11 studies. These comprised four published and two unpublished randomised controlled trials and five published case series reports. Three of the studies evaluated Ambu aScope2 and eight evaluated Ambu aScope, which is the immediate predecessor device.

Patient-based randomised studies

Studies reviewed by NICE included a randomised controlled trial by Kristensen (2013), which compared the Ambu aScope against a multiple-use fibre optic endoscope in 60 patients with expected normal airway and expected difficult airway. All patients were successfully intubated. The median total intubation time, including the administration of local anaesthetic, was 278 seconds for the Ambu aScope and 234 seconds for the multiple-use endoscope. Although this was statistically significant in favour of the multiple-use fibre scope (p<0.03), the investigators concluded that it was not clinically important because the difference was likely to be less than the hypothesised non-inferiority margin of 120 seconds. In another randomised controlled trial, Schoettker et al. (2012) compared Ambu aScope2 against a multiple-use fibre optic endoscope in 100 patients with difficult airways (simulated by a semi-rigid cervical collar). The use of the Ambu aScope2 was associated with a longer time to intubation compared with the fibre optic endoscope (69.5 vs 49.5 seconds, mean difference of 20 seconds, p<0.05). Overall, the image quality provided by the Ambu aScope2 was lower than with the fibre optic endoscope although the quality was judged subjectively to be excellent in 24 out of 50 cases and acceptable in another 22 out of the 50 cases. Two attempts were needed in four out of 50 cases with the Ambu aScope2 compared against eight out of 50 for the multiple-use fibre optic endoscopes. There was a 100% intubation success rate in less than four minutes for both devices. Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “There are an estimated 22,000 instances each year in the UK where there are unexpected difficulties with endotracheal intubation in patients. “The independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to support the use of 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 multipleuse fibre optic endoscope is unavailable. “As well as noting advantages during replacement of dislodged tracheostomy tubes in the intensive care setting, the Committee’s further preliminary recommendation is that making the Ambu aScope2 available for use across certain clinical settings is likely to improve outcomes and improve patient safety. The Committee also accepted that, based on cost modelling, the device is likely to save costs across a range of clinical settings and circumstances.” Lars Marcher, CEO of Ambu, commented: “The draft guidance states that the availability of the Ambu aScope 2 is likely to be cost-saving in all clinical settings evaluated and it has the potential to reduce the risk of brain-damage or even death caused by delayed patient intubation. When one of the world’s leading health technology assessment institutes delves deeply into the use of medical equipment, I think most people within the industry will sit up and take notice of their preliminary view. The draft guidance is especially relevant for the financially challenged health systems of today because NICE examines patient benefits as well as economic impact of the Ambu aScope 2.” Following a consultation period, the Advisory Committee will consider the comments received and prepare its final recommendations, which are expected in July 2013. More information on the medical technology draft guidance consultation is available at http://guidance.nice.org.uk/MT/158