Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The PneuX system consists of a class III device (endotracheal/tracheal tube) and a class IIb device (PneuX tracheal seal monitor, previously known as Venner tracheal seal monitor). The manufacturer, Venner Medical (Singapore) Pte, received a CE mark for the PneuX endotracheal and tracheostomy tubes on 20 March 2007 and for the tracheal seal monitor and extension tube on 22 October 2007.

Description

The PneuX system was formerly known as the Venner PneuX P.Y. ‑ VAP Prevention System and the Lo‑Trach system. It has also been referred to as the PneuX VAP prevention system, the PneuX P.Y. system and the Venner‑PneuX system. The system is designed to prevent VAP by minimising the risk of pulmonary aspiration and micro‑aspiration during long‑term mechanical ventilation, which is expected to be more than 24 hours but no more than 30 days.

The PneuX system consists of 3 component parts:

  • PneuX endotracheal/tracheostomy tube – a flexible silicone tube with a cuff, a flange, a drain tube, an inflation tube, a reservoir and a 15 mm standard connector. The tubes are compatible with magnetic resonance imaging (MRI) and are available in 3 sizes: 7.0, 8.0 or 9.0 mm inner diameter. A smaller PneuX endotracheal tube with an inner diameter of 6.0 mm is also available.

  • The PneuX tracheal seal monitor – an electronic automatic pressure controller for the inflation volume and pressure within the tube cuff during use.

  • Extension tube – a 2‑metre extension tube for the PneuX tracheal seal monitor. It connects the air outlet on the PneuX tracheal seal monitor and the pilot valve of the PneuX endotracheal/tracheostomy tube.

The system has the following main features:

  • Low‑volume, low‑pressure cuff and PneuX tracheal seal monitor – the low volume cuff is made from a soft silicone material. The PneuX tracheal seal monitor is an electronic automatic pressure controller which controls and maintains the safe inflation volume and pressure within the cuff during use. Its default setting is to maintain a constant low pressure on the tracheal wall (30 cm H2O), which is recognised to reduce the risk of tracheal mucosa injury compared with higher pressures. An intra‑cuff pressure of approximately 80 cm H2O is needed to produce a pressure of 30 cm H2O on the tracheal wall. By continuously adjusting and maintaining the pressure of the cuff against the trachea wall, the monitor is designed to allow the cuff to produce a tracheal seal without creases, which the manufacturer claims is optimal for reducing the risk of aspiration. The cuff and monitor also allow for intermittent increases in cuff pressure, allowing for safe airway irrigation. This is designed to reduce the risk of upper airway colonisation and to make it easier to remove detritus from the oropharynx.

  • Wire‑reinforced tube – the PneuX endotracheal/tracheostomy tube is a soft silicone wire‑reinforced tube, which conforms to the anatomy and requires a bougie for intubation.

  • Non‑stick coating of the inner lumen – the non‑stick lining reduces the risk of biofilm formation.

  • Boat tip – the tip of the PneuX endotracheal/tracheostomy tube is bevelled with a Murphy eye (an additional hole at the tip) to aid the tube's passage into the trachea. This is intended to allow atraumatic intubation and optimum adaptation to the airway.

  • Three suction ports – there are 3 subglottic secretion drainage and irrigation ports above the proximal end of the cuff to allow the tube to function properly even if a port is blocked. The small size of the subglottic ports is intended to prevent damage to the tracheal mucosa.

The manufacturer recommends that the PneuX endotracheal/tracheostomy tube and the PneuX tracheal seal monitor are used together, and so neither should be used with other devices.

Setting and intended use

The PneuX system can be used in intensive or critical care patients having mechanical ventilation, particularly in cases where the duration of intubation is expected to be more than 24 hours (but not more than 30 days). The PneuX system is also compatible with tracheal intubation during routine anaesthesia. It can be placed by anaesthetists and maintained by critical care nurses.

Current NHS options

VAP prevention strategies vary considerably in current practice.

In 2008, the Working Party on Hospital‑Acquired Pneumonia of the British Society for Antimicrobial Chemotherapy produced evidence‑based guidance (Masterton et al. 2008). The scope of the guidance excluded oral antiseptic treatments, severely immunocompromised patients, children under 16 years old and people with cystic fibrosis. The guidance states that measures should be taken to prevent VAP by reducing aspiration via subglottic secretion drainage, correct positioning of the tube and sufficient cuff pressure to avoid aspiration and tracheal damage.

The Patient Safety First How to Guide for critical care (2008) provides advice on mechanical ventilation and the NHS ventilator care bundle.

The NHS ventilator care bundle has 4 key components:

  • elevation of the head of the bed to between 30 and 45 degrees

  • daily sedative interruption and daily assessment of readiness to extubate

  • peptic ulcer disease prophylaxis and venous thromboembolism prophylaxis

  • appropriate humidification of inspired gas and appropriate tubing management.

The guide recommends that centres should monitor care bundle compliance and patient outcomes in order to assess the efficacy of this approach. These measurements include:

  • ventilator care bundle compliance, by determining the percentage of patients having all 4 components of the care bundle

  • cumulative count of the number of days that have passed without VAP being reported

  • average length of stay on mechanical ventilation

  • average length of stay in ICU

  • VAP rate per 1000 ventilator days.

Subglottic secretion drainage/suctioning is not included in the care bundle, because the bundle is intended to offer solutions that are rapidly and readily available to hospitals. However, the guide states that subglottic suctioning is an effective therapy for reducing VAP rates and that if an ICU has experience of doing the procedure it should continue to offer it.

The guide also states that although the bundle has omitted some interventions, the selection of a few well‑established measures serves to minimise risks to the patient. It also states that proper use of the ventilator bundle leads to near zero rates of VAP over prolonged periods of time.

The Scottish Intensive Care Society/Health Protection Scotland VAP prevention bundle – Guidance for implementation recommends 5 key elements to be addressed together to minimise the risk of VAP: sedation, weaning and extubation, patient positioning, oral antiseptics and subglottic secretion drainage. Of these the PneuX system would specifically address the last point, subglottic secretion drainage.

In 2011, the National Resource for Infection Control published High impact intervention No.5: Care bundle to reduce ventilation-associated pneumonia. It outlined 6 key ways to prevent VAP. These relate to patient positioning, sedation level, oral hygiene, subglottic aspiration, tracheal tube cuff pressure and stress ulcer prophylaxis. It recommends secretion drainage through the subglottic secretion port every 1–2 hours and cuff pressure measurements every 4 hours to maintain a pressure of 20–30 cm H2O. The PneuX system with the wall seal pressure maintained at approximately 30 cm H2O would specifically address the recommendation of subglottic aspiration drainage.

Overall, the various guidelines recommend the use of prophylactic antimicrobials, care bundles and patient positioning. Measures that are both specific to intubation tube selection and design and common to the various guidelines are secretion drainage through subglottic ports and sufficient cuff pressure to avoid aspiration and tracheal damage. The PneuX system includes both those features.

NICE is aware of other CE‑marked devices that appear to fulfil a similar function to the PneuX system. Examples include:

  • Microcuff endotracheal tube (Kimberly‑Clark)

  • Mallinckrodt Evac oral tracheal tube Seal Guard, Murphy Eye (Covidien)

  • Mallinckrodt Seal Guard (Covidien)

  • TaperGuard Evac oral tracheal tube (Covidien)

  • UnoFlex reinforced endotracheal tube (ConvaTec).

Costs and use of the technology

The PneuX system has the following costs (unit price, exclusive of VAT and carriage):

  • Endotracheal tube (size of 7.0, 8.0 or 9.0 mm inner diameter; MRI‑compatible): £150

  • Tracheostomy tube (size of 7.0, 8.0, or 9.0 mm inner diameter; MRI‑compatible): £175

  • Tracheal seal monitor: provided on loan basis to the hospital

  • Extension tube: provided at no charge to the hospital.

The PneuX endotracheal/tracheostomy tube and the extension tube are sterile and for single patient use. The shelf life for the PneuX endotracheal/tracheostomy tube is 2 years. The tubes are packed as single units and supplied as a box of 10 units of a single size. The extension tube is available separately. The manufacturer provides a comprehensive training programme at no additional cost to the hospital/trust. There are no maintenance or calibration requirements for the system and the PneuX tracheal seal monitor is serviced at 2‑year intervals by the manufacturer at no additional cost.

In the NHS, the standard intubation tube (and their cost) varies from department to department. A number of example standard tubes and their costs is shown below (price of each tube exclusive of VAT; supplied in a box of 10 tubes):

With subglottic suction:

  • Smiths Medical Portex oral endotracheal tube cuffed with Murphy eye and SACETT suction above cuff (inner diameter 7.0 mm, outer diameter 10.4 mm): £7.80

  • Covidien TaperGuard EVAC Tracheal standard endotracheal tube, cuffed with Murphy eye (inner diameter 7.0 mm, outer diameter 9.5 mm): £11.60

  • PROACT PRO‑Breathe standard endotracheal Tube, cuffed with Murphy eye evacuation lumen (inner diameter 7.0 mm): £3.25.

Without subglottic suction:

  • Smiths Medical Portex standard endotracheal tube cuffed with Murphy eye, clear low‑pressure cuff (inner diameter 7.0 mm): £1.35

  • PROACT PRO‑Breathe standard endotracheal tube, cuffed with Murphy eye oral/nasal PVC low‑profile cuff (inner diameter 7.0 mm): £1.12.

Likely place in therapy

The PneuX system would be used in place of standard endotracheal or tracheostomy tubes which have no subglottic access, subglottic access but with a high‑pressure cuff, or no continuous cuff‑pressure monitor, during long‑term intubation (which is expected to be more than 24 hours but no more than 30 days).

Specialist commentator comments

One specialist commentator considered that maintaining a constant cuff pressure is a very beneficial feature of the PneuX system, and that continuous cuff‑pressure monitoring should further reduce the risk of micro‑aspiration. At present, in their ICUs, cuff pressure is measured once per nursing shift (that is, once every 8 hours) and there is a tendency for cuff pressure to fall during this time.

One specialist commentator was concerned that there may be some difficulties in predicting which patients will be intubated for more than 24–48 hours, which could lead to an increased risk of having to change the endotracheal tube. Reintubation may cause a problem for some patients, particularly those with severe burns and swollen airways in whom it would not be advisable to change a tube.

A specialist commentator noted that the smaller PneuX endotracheal/tracheostomy tubes have a significantly larger external diameter than comparable tubes. For example, the PneuX endotracheal/tracheostomy tube with an inner diameter of 6.0 mm has an outer diameter of 9.9 mm, compared with 9.0 mm for other endotracheal tubes. This may lead to difficulties during tube changes if the anaesthetist is not aware of the difference.

Another specialist commentator thought that the PneuX system may assist critical care nurses and doctors in reducing incidences of VAP, but that more robust research needs to be done.

Equality considerations

NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

Risk factors for VAP include age (incidence increases with advancing age) and chronic illnesses (underlying chronic lung disease), which may significantly affect activities of daily living to the point where a person can be considered to be disabled. Age and disability are protected characteristics under the Equality Act (2010).