NGPod-P

  • Research type

    Research Study

  • Full title

    Comparing a novel device (NGPod) to standard practice for ascertaining the positioning of nasogastric tubes (NGTs) in paediatric inpatients

  • IRAS ID

    295061

  • Contact name

    Rachel Elvins

  • Contact email

    rachel.elvins@mft.nhs.uk

  • Sponsor organisation

    NGPod Global

  • Duration of Study in the UK

    0 years, 3 months, 4 days

  • Research summary

    Research Summary

    Most nasogastric tubes (NGT) 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. The use of a misplaced NGT is currently classified as a Never Event by NHS England.
    Current NHSI (NPSA) guidelines recommend pH testing of aspirate obtained from the NGT. This can be a difficult procedure with only approximately 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 sent for X-Ray to determine NGT position. There are also issues with misinterpretation of the X-Ray, as well as exposure to radiation from the X-Ray itself.
    The study sets to compare a new fibre optic device, NGPOD, that gives an unambiguous result as to the pH of the environment at the tip of the NGT with current standard practice to determine if the device is at least as reliable as testing of pH aspirate and whether a result is obtained more often using the device which would reduce the requirement for X-Rays reducing the risk to patients of repeated exposure and of injury/death due to misinterpretation of the result.
    Previous research has been conducted with adults to assess this. The current research will test NGPod in children and young people who are inpatients at Galaxy House, who have mental health issues requiring a NGT to be inserted as part of their routine care.

    Summary of results

    This study aimed to find out whether use of a brand-new instrument (NGPOD®) was as reliable, effective, and accurate in confirming whether a nasogastric tube (NGT) is appropriately positioned in the stomach as the current testing method. A nasogastric tube is a tube which is passed via the nose, down the throat and into the stomach and is a way of giving food, fluids and medications to a patient who is not able to accept these things in the usual way. The current method requires drawing up of fluid from the patient’s stomach via the tube, for testing to confirm the presence of stomach acid. The tube can only be used safely once an appropriate acidity level is confirmed.
    The use of incorrectly positioned NGTs is classed as a “Never Event” which is a serious incident or error that should not occur if proper safety procedures are followed. Using an incorrectly positioned NGT could lead to fluids being introduced into the patient’s airway, or another part of their body, instead of their stomach. This could lead to significant physical and psychological harm.
    Current methods mean that in situations where the correct acidity level cannot be confirmed, either because fluid cannot be drawn up from the stomach or because the results cannot be understood, young people may have to have an Xray scan of their chest, to confirm whether the tube is in the right place.
    The participants for this study were a group of young people aged between 10 to 18 years, who required a nasogastric tube to be inserted as part of their care at Galaxy House, an inpatient unit for young people under the care of Child & Adolescent Mental Health Services (CAMHS). This is the first study which has evaluated this instrument for use in the care of young people.
    As well as assessing the reliability, effectiveness, and accuracy of the NGPOD® instrument, we also wanted to measure some other outcomes from this study. These included the number of patients who needed an Xray scan of their chest following each testing method; the time taken to get a result for each testing method, and how acceptable the young people found each testing method.
    We proposed that if using the NGPOD® was found to take less time than current methods, this may also lead to a reduction in avoidable delays to providing food, fluids, and medication to young people via their NGT. We also proposed that if the instrument was as reliable, effective, and accurate in confirming safe NGT position, there may be a reduction in the need for chest scans, which would mean that young people could avoid the risks of exposure to Xrays.
    The results of this study show us that the NGPOD® test is not equivalent to current methods, in terms of reliability, effectiveness and accuracy. The results do confirm that the NGPOD® device is quick to use. Patient satisfaction responses suggest that there are aspects of the NGPOD® testing method which some young people may find preferable to current methods. We recognise that there is potential for this device to have a significant positive impact on young people’s experience of care. We discuss the potential impact of user error on our results and make suggestions for future studies.

  • REC name

    West of Scotland REC 5

  • REC reference

    21/WS/0152

  • Date of REC Opinion

    22 Dec 2021

  • REC opinion

    Further Information Favourable Opinion