Advice

Summary

Summary

The CORTRAK 2 Enteral Access System (EAS) is designed to help guide the placement of nasoenteral feeding tubes and to help confirm that they are correctly placed. It uses an electromagnetic sensor to track the path of the feeding tube during the placement procedure. Relevant evidence was mainly from studies of CORTRAK EAS in placing post-pyloric tubes in ICU patient populations. The evidence shows that the time to placement, technical success and safety of CORTRAK EAS for post-pyloric tubes is similar to endoscopic placement; some outcomes were better when compared with blind placement, but CORTRAK EAS increased the time needed for post-pyloric tube placement in children. No evidence was found in relation to the use of CORTRAK EAS for guiding nasogastric tube placement.

The device costs £12,000 excluding VAT. Consumable costs per patient are £51 for a nasogastric tube and £103 for a post-pyloric tube, compared with prices of £7 and £70 for corresponding standard tubes. Confirmation of correct placement using conventional procedures will incur additional costs.

A patient safety alert issued by NHS England (2013) states that it is vital that healthcare professionals use pH or X-ray testing to confirm correct placement of nasogastric tubes after initial insertion, even when using placement devices.

Product summary and likely place in therapy

  • The CORTRAK 2 Enteral Access System (EAS) is used to aid the placement of nasoenteral feeding tubes passed through the nose into either the stomach (nasogastric), duodenum (nasoduodenal) or jejunum (nasojejunal). The latter 2 types are also known as post-pyloric placement.

  • CORTRAK 2 EAS would be used in place of, or in addition to, existing methods of tube placement in people of all ages who need nasoenteral feeding.

Effectiveness and safety

  • The published evidence summarised in this briefing comes from 7 studies (n=667 patients; 681 placements) and includes 3 randomised controlled trials (RCTs). Only 1 of the studies was done in the UK and this was the only study of nasogastric tube placement. Most studies drew patients from an ICU setting.

  • Three RCTs and 3 prospective cohort studies provide evidence on the use of CORTRAK EAS for guiding post-pyloric or nasogastric tube placement and 1 prospective cohort study provides evidence on confirmation of post-pyloric tube placement.

  • One RCT (n=66) compared CORTRAK EAS with the standard endoscopic technique and found that post-pyloric (nasojejunal) feeding tube placement using CORTRAK was as fast, safe and successful as the endoscopic method in an adult ICU population.

  • A second RCT (n=49) compared CORTRAK EAS with blind post-pyloric tube placement and found that CORTRAK EAS increased the time needed for accurate placement in critically ill children.

  • A third RCT (n=37) compared CORTRAK EAS with blind placement of post-pyloric tubes and found that CORTRAK EAS was faster and more effective in and adults.

  • Two prospective cohort studies (1 in adults [n=101] and 1 in children [n=107]) compared CORTRAK EAS with blind post-pyloric tube placement and concluded that CORTRAK EAS was a safe and effective method of guiding post-pyloric tube placement.

  • One prospective cohort study in adults (n=113) compared CORTRAK EAS with existing methods such as pH and X-ray and concluded that CORTRAK EAS can accurately guide nasogastric tube placement.

  • One prospective cohort study of post-pyloric tube placement in children (n=18) and adults (n=176) compared CORTRAK EAS with X-ray and concluded that CORTRAK EAS can accurately confirm tube placement.

Technical and patient factors

  • A Patient Safety Alert issued by NHS England in 2013 states that it is vital that healthcare professionals perform pH or X-ray testing to confirm correct placement of nasogastric tubes after initial insertion even when using placement devices. The alert was issued following reports of 2 deaths after enteral nutrition was unintentionally given into the respiratory tract through a misplaced nasogastric tube inserted with the aid of a placement device.

  • CORTRAK 2 EAS uses electromagnetic sensing technology to track and display the path of a feeding tube during placement.

  • The system consists of an LCD monitor unit, specific nasoenteral feeding tubes each containing a stylet with a transmitter, and a signal receiver unit.

  • CORTRAK 2 EAS is intended for use by trained operators in a secondary care setting.

  • The included studies used CORTRAK 2 EAS or the previous operationally identical version, CORTRAK EAS (collectively referred to as CORTRAK EAS in this briefing).

  • CORTRAK EAS must be used with proprietary CORTRAK feeding tubes.

Cost and resource use

  • CORTRAK 2 EAS costs £12,000 excluding VAT. Consumable costs per patient are £51 for a nasogastric tube and £103 for a post-pyloric tube compared with prices of £7 and £70 for corresponding standard tubes. Confirmation of placement by conventional methods such as X-ray or pH testing will incur additional costs.

  • Two conference abstracts and 4 published articles considered the cost and resource consequences of using CORTRAK EAS. All studies analysed a small prospective or retrospective cohort. Three were based in the USA and 3 in the UK.

  • Four of the studies compared nasoenteral feeding using CORTRAK EAS with conventional bedside placement and provided some evidence of relative cost savings.

  • Two of the studies did not compare resource use. One estimated the overspend in a single ICU from the combined use of CORTRAK EAS and X-rays to confirm nasogastric tube placement. The other costed the system from the perspective of a single NHS trust and found it reduced the number of X-rays and endoscopic feeding tube placements needed, both of which could be associated with a cost reduction.