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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Adam Partington
+44 (0)7500047676
apartington@ngpodglobal.com


Study Location:

Royal Preston Hospital
Sharoe Green Lane Fulwood
Preston
PR2 9HT


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NGPOD pH test Vs pH measurement to assess Nasogastric Tube (NGT) position

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Nutrition or medication administered via a nasogastric tube


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
A nasogastric tube (NGT) is a narrow tube that is passed into the stomach via the nose for nutritional support or removal of stomach contents (aspirate). Use of misplaced NGT was first recognised as a patient safety issue by the National Patient Safety Agency (NPSA) in 2005 (NPSA, 2005) and three further alerts were issued by the NPSA and NHS England between 2011 and 2013. Introducing fluids or medication into the respiratory tract or pleura via a misplaced NGT is considered a Never Event by NHS England. Never Events are considered preventable but the current methods for determining correct placement of NGTs are open to clinical interpretation. The existing British National Patient Safety Agency (NPSA) safety guideline recommends testing the pH of NGT aspirates. Feeding is considered safe if a pH of 5.5 or lower has been observed, otherwise chest X-rays are recommended. Most NGTs placed in the UK are inserted "blind" - i.e. the inserting method does not use a form of visualisation to establish that they are in the correct position prior to use. Current NHSI (NPSA) guidelines recommend that pH testing of aspirate obtained from the NGT is the first-line method of confirmation. This can be a difficult procedure with only about 60% success in obtaining aspirate and, where aspirate is obtained, a variety of human factors can affect the accurate interpretation of the result. Inability to obtain aspirate currently means that patients are then sent for an x-ray to determine the NGT position. NHSI Level 2 Alert July 2016 identified misinterpretation of the x-ray as the root cause of 45% of NGT related Never Events in the preceding 12 months. A new fibreoptic device, NGPOD, gives an unambiguous result as to the pH of the environment at the tip of the NGT. This study aims to compare use of the device with current standard practice to determine if the device is at least as reliable as testing of pH aspirate. The study will also aim to investigate whether a result is obtained more often using the device which would potentially reduce the requirement for x-rays and reduce the risk to patients of repeated exposure.

Who can participate?
Patients aged 18-85 requiring a NGT as part of their treatment

What does the study involve?
The NGPod fibre optic placement confirmation device is used before standard testing with in the first instance pH testing with pH strips of gastric aspirate obtained from the NGT. If aspirate cannot be obtained or the results from the pH test are inconclusive the standard secondary test of chest x-ray is used to determine the position of the NGT, in line with local guidelines. The results from one or both standard tests are compared to the result from the NGPOD System to determine whether the NGPOD System is at least as accurate as the current standard testing methods.

What are the possible benefits and risks of participating?
No direct positive benefits but the research may lead to a safer and more cost-effective method for NGT placement. Use of the device may lead to a reduction in the requirement for X-rays which would reduce the exposure of patients to x-rays. Possible risks include the additional time required to carry out the NGPod test which will delay nutrition being administered by 20 minutes.

Where is the study run from?
Royal Preston Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2018 to March 2020

Who is funding the study?
NGPod Global Ltd (UK)

The NGPOD fibre optic medical device is as reliable in establishing the position of an Nasogastric Tube as current standard methods on both initial insertion and repeat testing.


Single-center parallel diagnostic study

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Sep 2018

01 Apr 2019

Interventional

Intervention Type : Device
Intervention Description : The NGPod fibre optic placement confirmation device will be used prior to the current standard method of confirming NGT position.

The methodology is a feasibility/pilot study and doesn’t require randomisation. The participants will not be allocated into groups at random but selected simply on their availability and fitting into the required age bracket (18-85).

The study will include adults between the age of 18-85 who require a nasogastric tube as part of their treatment in order to receive hydration/nutrition/medication via the nasogastric tube or who are having the initial insertion of the NGT for other reasons.

The study is to include two cohorts of research participants:Patients who have had a new nasogastric tube inserted to establish position immediately following insertion (INITIAL INSERTIONS)Patients receiving ongoing therapy via NGT prior to a new episode of therapy being administered (REPEAT TESTING)

For both groups the NG POD system will be used prior to standard testing with in the first instance pH testing with pH strips of gastric aspirate obtained from the NGT. If aspirate cannot be obtained or the results from the pH test are inconclusive the standard secondary test of chest x-ray will be used to determine the position of the NGT, in line with local guidelines.

The results from one or both standard tests will be compared to the result from the NGPOD System to determine whether the NGPOD System is at least as accurate as the current standard testing methods.


You can take part if:


Current participation inclusion criteria as of 10/01/2019:Male or female aged over 18 years of age who require a nasogastric tube for nutrition, hydration or medication.

Previous participant inclusion criteria:Male or female aged 18-85 requiring a nasogastric tube as part of their treatment




You may not be able to take part if:

1. Children under the age of 182. Those not requiring a nasogastric tube as part of their treatment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Preston Hospital
    Sharoe Green Lane Fulwood
    Preston
    PR2 9HT


The study is sponsored by NGPod Global and funded by NGPod Global Ltd .



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for Trial ID: ISRCTN14985496

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