Analyser to Confirm Nasogastric (NG) Tube Placement at the Bedside (#2070)

Idea Description
Supplementary Information
Detailed Submission Data
Innovation 'Elevator Pitch':
Development of a portable device that will rapidly and accurately determine whether an NG tube has been correctly placed into the stomach.
Overview of Innovation:
Many patients in hospital are unable to swallow safely, and therefore need to be fed by an NG tube passed down their nose into their stomach. Before any liquids can be given to the patient down the tube, it is essential that it is proven to be in the stomach. If it is not in the stomach, there is a danger that the food or drugs given will be delivered into the lungs, which is highly dangerous and completely unacceptable.
The normal way of confirming that the tube is correctly placed is for a small amount of gastric acid to be aspirated up the tube, and the pH confirmed to be <5.5. This should be done each and every time before the tube is used – this may be many times in a 24-hour period.
Approximately one third of the time, it is not possible to confirm correct tube placement this way – either acid cannot be aspirated, or the pH is >5.5. In these cases, an Xray is required to confirm tube placement. This leads to delays in the tube being used for essential nutrition / drugs, to disruption to the patient experience, to additional radiation, and to additional use of other hospital resources (eg portering the patient to Xray).

We are currently working with Warwick University to build a portable analyser to put into a hospital. We have designed a pilot study to evaluate the scientific method we have developed, which has received ethical approval. If the results are favourable, we envisage a larger trial in multiple centres.
Stage of Development:
Trial stage - Trial stage to prove that the idea actually works as intended
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Innovation 'Elevator Pitch':
Ingenza has developed an NG tube placement verification assay that is more sensitive, lower cost and consistent with current medical practice that could reduce unnecessary X-rays by >90%.
Overview of Innovation:
~1 million nasogastric (NG) feeding tubes are used annually in the UK, (10 million in the EU), with use growing at 7% per year driven by an ever aging population.  NG feeding tubes are inserted into the stomach via the nose and esophagus to feed and medicate hospital patients and others requiring enteral nutrition.  NG feeding tube misplacement (to the lungs) is a major unresolved problem causing patient injury or even death.  Prior to initiating patient feeding/medication, correct NG tube placement in the stomach must be confirmed by bedside pH paper assay of a tube aspirate reading ≤pH5.5 (due to gastric acid).  Up to 40% of NG intubated patients have reduced/no gastric acid and so require chest X-rays to confirm tube placement before feeding/medication.  Confirmation of NG feeding tube placement through X-rays result in (i) increased NHS costs, exposure of patients to ionising radiation, treatment delays, and poor patient/bed management.  Ingenza has developed an NG tube placement verification assay that is more sensitive, lower cost and consistent with current medical practice that could reduce unnecessary X-rays by >90%.  Ingenza conceived a new enzyme-based diagnostic test for NG tube placement verification.  Our test is simple and low cost with high sensitivity/specificity.  Moreover, by augmenting the current pH-based placement test, our assay requires no alteration to existing NHS procedures and no additional training for deployment in clinical practice.  Our test detects the impact of organic acid release from an ester substrate (impregnated onto modified pH paper) by the action of a stomach-specific enzyme - human gastric lipase (HGL).  An Innovate UK BioMedical Catalyst-funded multi-hospital trial of Ingenza’s assay is underway involving >200 patients.  Ingenza is actively seeking collaborators/partners to: (i) accelerate clinical evaluation/adoption of our proprietary NG feeding tube placement assay and (ii) make, market, distribute and sell Ingenza’s enhanced NG tube placement verification assay.
Stage of Development:
Evaluation stage - Representative model or prototype system developed and can be effectively evaluated
WMAHSN priorities and themes addressed: 
Wealth creation / Innovation and adoption / Patient and medicines safety / Person centred care
Benefit to NHS:
Our enzyme-augmented diagnostic test, being more sensitive than current alternatives, could greatly reduce reliance on expensive chest x-rays to confirm NG feeding tube placement.
Online Discussion Rating
6.00 (1 ratings)
Initial Review Rating
4.40 (2 ratings)
Benefit to WM population:
​Our enzyme-augmented diagnostic test, being more sensitive than current alternatives, by greatly reducing reliance on expensive chest x-rays to confirm NG feeding tube placement will improve patient health/safety, reducing lengthy feeding delays and inefficiencies in patient management.
Current and planned activity: 
In 2011 Ingenza completed a feasibility study at St Mary’s Hospital.  The 36 patient trial demonstrated tributyrin-impregnated pH strips to be >97% accurate in confirming correct NG feeding tube placement, compared with the 65% accuracy of standard pH strip tests, a significant improvement in test sensitivity.  Ingenza and Imperial College secured an £800,000 IUK Biomedical Catalyst award in 2015 to fund a larger trial of the augmented pH strips.  The is currently underway with >200 patients in multiple NHS hospitals and Trusts.  The BMC award also supports development of a 2nd generation enzyme-augmented pH assay that can provide a potentially simpler “yes/no” output, analogous to a pregnancy test.  The award also funds development of ISO-compliant strip manufacturing protocols and, via the NIHR-DEC, a techno-economic analysis as well as an investigation into potential barriers to adoption and human factors, all in support of effective product adoption. 

What is the intellectual property status of your innovation?:
Ingenza has filed patents worldwide to protect its intellectual property on the enzyme-augmented NG tube placement verification assays.  The US patent was granted in 2014.  There is a notice to grant in European countries and the company is currently pursuing patent issuance in India and Canada.
Return on Investment (£ Value): 
Return on Investment (Timescale): 
6-12 mon
Ease of scalability: 
Investment activity:
Investment to date in developing the improved NG feeding tube placement verification assay has been through a combination of grant funding from Scottish Enterprise and Innovate UK (to Ingenza and Imperial College / St. Mary's Hospital) as well as support from Ingenza's internal funds.
Regional Scalability:
Ingenza's improved NG feeding tube placement verification assay involves the use of a modified pH paper.  As such it requires not change in medical practice for deployment in patient care and it is fully scalable across all NHS regions.
Ingenza key product outcomes/metrics include (i) a significant (>90%) reduction in unecessary x-ray costs/exposure associated with misinterpretation of NG feeding tube placement, (ii) a significant (>90%) reduction in feeding/medication delays and hosiptal stays/bed occupation associated with such uncessary x-rays and (iii) an elimination of patient injury/death associated with NG feeding tube misplacement.
Adoption target:
We expect a 100% replacement of current NG feeding tube placement assay beased on current unmodified pH paper strip tests.
Investment sought:
N/A.  Ingenza is fully able to support the production/distribution of our improved NG feeding tube placement assay.  We are seeking support from the NHS for the adoption and recommendation use of our improved assay.
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