Plain English Summary
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 November 2018
Who is funding the study?
NGPod Global Ltd (UK)
Who is the main contact?
Adam Partington
apartington@ngpodglobal.com
Trial website
Contact information
Type
Public
Primary contact
Mr Adam Partington
ORCID ID
Contact details
BASE Building
Manchester Science Park
Manchester
M15 6JJ
United Kingdom
+44 (0)7500047676
apartington@ngpodglobal.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C_FM_001_Protocol
Study information
Scientific title
Current scientific title as of 10/01/2019:
NGPOD® pH test compared to current NHS Trust practice to determine Nasogastric Tube (NGT) position
Previous scientific title:
NGPOD vs standard pH testing to confirm NGT position
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Single-center parallel diagnostic study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Nutrition or medication administered via a nasogastric tube
Intervention
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.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Result of NGPod test (Green Tick/Red Cross displayed on the device), recorded in CRF
2. Result of Aspiration pH (pH scale 1-7), recorded in CRF
Secondary outcome measures
1. Result of x-ray (if required) – positive or negative confirmation (Yes/No)
2. Time for NGPod test (minutes and seconds), recorded in CRF
3. Time for Aspirate test (minutes and seconds), recorded in CRF
Overall trial start date
01/06/2018
Overall trial end date
01/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 unique individuals
Participant exclusion criteria
1. Children under the age of 18
2. Those not requiring a nasogastric tube as part of their treatment
Recruitment start date
15/09/2018
Recruitment end date
01/04/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
NGPod Global
Sponsor details
BASE
Manchester Science Park
Manchester
M15 6JJ
United Kingdom
+44 (0)7500047676
apartington@ngpodglobal.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
NGPod Global Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results will be published on the hospital trust website.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/11/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list