NGPOD pH test Vs pH measurement to assess Nasogastric Tube (NGT) position
| ISRCTN | ISRCTN14985496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14985496 |
| Secondary identifying numbers | C_FM_001_Protocol |
- Submission date
- 01/06/2018
- Registration date
- 05/06/2018
- Last edited
- 07/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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)
Who is the main contact?
Rosemary Howell
Rosemary@rosemaryhowell.co.uk
Contact information
Scientific
Unit 7
Berkeley Court
Manor Park
Runcorn
WA7 1TQ
United Kingdom
 ORCID ID |
0000-0001-5669-3203 |
|---|---|
| Phone | +44 (0)7775 560479 |
| Rosemary@rosemaryhowell.co.uk |
Study information
| Study design | Single-center parallel diagnostic study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Approved 22/02/2019, North West - Haydock Research Ethics Committee (3rd Floor - Barlow House, 4 Minshull Street Manchester, M1 3DZ, UK; +44 (0)207 104 8012; nrescommittee.northwest-haydock@nhs.net), REC ref: 19/NW/0019 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | NGPOD fibre optic medical device |
| 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 study start date | 01/06/2018 |
| Completion date | 19/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 unique individuals |
| Total final enrolment | 177 |
| Key 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 |
| Key exclusion criteria | 1. Children under the age of 18 2. Those not requiring a nasogastric tube as part of their treatment |
| Date of first enrolment | 15/09/2018 |
| Date of final enrolment | 01/04/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Industry
BASE, Manchester Science Park
Manchester
M15 6JJ
United Kingdom
| Phone | +44 (0)7500047676 |
|---|---|
| apartington@ngpodglobal.com | |
| Website | http://ngpodglobal.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 19/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results will be published on the hospital trust website. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v0.4 | 19/07/2019 | 05/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 08/12/2022 | 07/12/2023 | Yes | No |
Additional files
Editorial Notes
07/12/2023: Publication reference added.
05/10/2022: The following changes have been made and the plain English summary updated accordingly:
1. A scientific contact has been updated.
2. Uploaded protocol (not peer reviewed).
04/01/2020: Ethics approval details added.
08/12/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/11/2018 to 19/03/2020.
2. The intention to publish date was changed from 01/11/2020 to 19/03/2021.
3. Total final enrolment number added.
10/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 01/11/2018 to 01/04/2019.
2. The intention to publish date from 01/11/2019 to 01/11/2020.
3. The scientific title has been updated.
4. The participant inclusion criteria has been updated.
