Advice

Technology overview

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 health care professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The TaperGuard Evac oral tracheal tube is a class IIa medical device for which the manufacturer, Covidien, received a CE mark in April 2009. The TaperGuard Evac oral tracheal tube had its CE mark renewed in June 2012.

Description

The TaperGuard Evac oral tracheal tube is intended to help prevent microaspiration of fluid into the lungs, which can cause VAP. It is a sterile, single‑use endotracheal tube with a taper‑shaped cuff and integrated subglottic drainage. The subglottic drainage is done through a separate evacuation lumen (the 'Evac'), which has a dorsal opening port above the cuff in addition to the main lumen. The lumen is accessed through a clear connecting tube with a capped Luer connector. The tapered cuff is designed to be better than a conventional cuff in reducing microaspiration of bacteria‑laden secretions from the upper airway into the trachea. The TaperGuard Evac oral tracheal tube is made of polyvinyl chloride (PVC) and is latex free.

The tube is shaped in a Magill curve, which is widely recognised to be the optimum shape for most airways, and is made up of the following:

  • Tapered cuff with a cuff inflation valve. The cuff is an inflatable area in the section of the endotracheal tube that sits inside the patient's trachea. The cuff forms a seal against the tracheal wall which prevents gases from leaking past the cuff, allowing positive pressure ventilation. The cuff also prevents matter such as regurgitated gastric contents going into the trachea. The cuff is made of PVC and is latex free.

  • Suction port above the cuff with the Evac lumen.

  • Hooded tip with a Murphy Eye. The Murphy Eye is an additional hole at the tip which allows gas to flow through the tube even if the main opening of the endotracheal tube is blocked, for example if it gets pressed against the tracheal wall. Without the Murphy Eye, the endotracheal tube could be completely obstructed.

  • Tip‑to‑tip radiopaque line to give visibility in X‑rays.

The TaperGuard Evac oral tracheal tube is sold in sterile packages, and is available in a range of sizes and lengths of (inner diameter [mm]/outer diameter [mm]/length [mm]): 6.0/9.8/354.0, 6.5/9.8/366.0, 7.0/10.4/375.0, 7.5/11.2/375.0, 8.0/11.8/376.0, 8.5/12.6/376.0 and 9.0/13.1/377.0. The tube is intended for oral intubation only.

The cuff pressure of the TaperGuard Evac oral tracheal tube is monitored by a cuff controller that automatically keeps the pressure constant. This compensates for small leaks in the system, and therefore reduces the risk of aspiration. The manufacturer states that use of the pressure cuff controller is essential to ensure optimal performance of the TaperGuard Evac oral tracheal tube. The cuff pressure can either be constant or intermittent. The cuff controller is pre‑set to a standard pressure of 25 cmH2O, and the manufacturer recommends that the pressure should not exceed this. The cuff controller can also be used with other types of endotracheal tubes; some types of endotracheal tube cuffs can be used at pressures of up to 60 cmH2O. Clinical staff determine the ideal cuff pressure for each patient according to the ventilation method and type of endotracheal tube used.

The aspiration system consists of a suction pump, disposable connecting PVC tube, disposable reservoir and disposable hydrophobic filter with PVC adapter. When connected to the TaperGuard Evac oral tracheal tube, the aspiration system removes secretions from the subglottic space by suction.

Intended use

The TaperGuard Evac oral tracheal tube is indicated for airway management by oral intubation of the trachea (that is, a tube inserted into a patient's trachea through the mouth to maintain an open airway) and for evacuation or drainage of the subglottic space.

The TaperGuard Evac oral tracheal tube can be used in all patients in an intensive therapy unit (ITU) or ICU who need airway management by oral intubation of the trachea and drainage of the subglottic space.

The TaperGuard Evac oral tracheal tube should not be used for people having procedures using lasers or electrosurgical active electrodes close to the device. Contact with the laser beam or electrode, in the presence of oxygen or nitrous oxide‑enriched mixtures, could result in rapid combustion of the tracheal tube, potentially causing burns and releasing harmful chemicals.

Setting and intended user

The TaperGuard Evac oral tracheal tube can be used in ITU and ICU settings by appropriately trained personnel such as nurses or anaesthetists. Placement of endotracheal tubes by inadequately or inappropriately trained personnel could result in serious injury to the patient.

Current NHS options

NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the TaperGuard Evac oral tracheal tube:

  • Microcuff endotracheal tube (Kimberly‑Clark)

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

  • Mallinckrodt Seal Guard (Covidien)

  • LoTrach (Venner)

  • UnoFlex reinforced endotracheal tube (ConvaTec).

Costs and use of the technology

The TaperGuard Evac oral tracheal tubes and additional accessories have the following costs:

  • box of 10 single‑use TaperGuard Evac oral tracheal tubes (any size): £111.07

  • reusable automatic cuff controller (illustrative price based on Shiley model): £1000

  • reusable suction pump: £700

  • 10 non‑reusable reservoirs: £55

  • 10 non‑reusable hydrophobic filters: £130

  • 10 non‑reusable suction tubes: £20.

The manufacturer states that intracuff pressure management is a key factor in the performance of the TaperGuard Evac tube and any cuffed endotracheal tube. It recommends that the TaperGuard Evac tube should be used with the Shiley Pressure Control (reusable automatic cuff controller). The manufacturer states that using the TaperGuard Evac oral tracheal tube without the cuff controller may result in reduced effectiveness, depending on the type of cuff pressure management chosen.

Secretions can be suctioned for removal using other generic automatic or manual devices but the manufacturer does not recommend this.

The remaining accessories in the list above are recommended by the manufacturer for use with the TaperGuard Evac oral tracheal tube. The CE marking for the TaperGuard Evac oral tracheal tubes does not dictate the use of any particular accessories.

The number and variety of available endotracheal tubes makes a direct cost comparison difficult. However, alternatives to the TaperGuard Evac cost between £80 and £220 per box of 10 tubes.

Likely place in therapy

The TaperGuard Evac oral tracheal tube is intended to replace endotracheal tubes which have no subglottic access or those with a cylindrical or barrel‑shaped cuff.

Specialist commentator comments

One specialist commentator noted that the amounts of subglottic secretions from different patients vary, ranging from no secretions at all to 20 ml per day.

This commentator remarked that no safety issues in their critical care unit had occurred with the use of the TaperGuard Evac oral tracheal tube. They noted that this device is also being used in non‑critical care areas such as the emergency department and operating theatre, where patients are ventilated, and again no safety problems had been observed in these settings.

Another commentator pointed out that the published data suggest that subglottic suctioning is effective in preventing VAP, and also noted that several brands of tracheal tubes that have subglottic suction are available but that there is no clear evidence to show which of these is better. The commentator stated that subglottic suctioning is already included in the 2011 high impact intervention care bundle to reduce ventilation‑associated pneumonia (Department of Health, 2011), but estimated that about 75% of UK ICUs have not adopted this aspect. The main reason for this is the higher price of these tracheal tubes, although the commentator considered this to be an insignificant cost compared with the costs of treating VAP. One commentator stated that VAP is a major problem in the UK, with a significant financial burden for treatment which they estimated to be typically about £10,000 per case, in addition to serious health consequences and potential death of the patient (VAP has an attributable mortality of 13%). This commentator reflected that some simple evidence‑based interventions to prevent VAP do exist and are highly likely to be effective, but felt that these are underused in the NHS.

One specialist commentator had found the TaperGuard Evac oral tracheal tube with the continuous cuff monitoring easy to use. They noted that training is straightforward and education time is relatively short.

One commentator pointed out that different brands of tracheal tubes are used in the NHS. Another commentator clarified that the manufacturer supplies the TaperGuard Evac oral tracheal tube in pre‑selected lengths, and it is only intended for oral intubation.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim 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, in the way we produce our guidance (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). Age and chronic conditions are protected characteristics under the Equality Act (2010).