Diagnostic accuracy of point-of-care enzymatic test for nasogastric tube placement
| ISRCTN | ISRCTN11170249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11170249 |
| IRAS number | 192968 |
| Secondary identifying numbers | IRAS 192968 |
- Submission date
- 11/05/2017
- Registration date
- 21/06/2017
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
A nasogastric tube (NGT) is a tube used for giving medication and nutrition that is passed into the stomach via the nose. At least 1 million nasogastric tubes (NGT) are used in the UK each year, often for supplementary feeding in patients unable to swallow. These are tubes that are placed from the nose to the stomach to allow liquid feed to be passed directly into the stomach. It is important that these tubes are correctly placed before use as misplacement can lead to serious complications and even death. The current best practice uses pH testing (measuring acidity or alkalinity) to gastric (stomach) aspirates (matter that has been drawn from the body by suction) to ensure correct positioning in the stomach. This has limitations as it is not always possible to collect an aspirate and up to 42% of patients receive medications that reduce acid in the stomach. In these patients, feeding is often delayed as patients have to wait for a repeat aspiration or undergo a chest x-ray. The ideal solution would be a test that was accurate, safe and rapid even in the context of non-acidic gastric aspirates. Gastric lipase is an enzyme produced in the stomach and therefore if present in aspirates from nasogastric tube confirms correct placement. However, gastric lipase is inactivated by acidic stomach contents and therefore is unsuitable as means of determining nasogastric tube position on its own. The aim of this study is to find out whether a combined test for pH and gastric lipase is as accurate as the current best practice technique of a standard pH test.
Who can participate?
Adult patients who need NCT placement as part of their care.
What does the study involve?
As part of normal clinical management, the NG tube is checked before being used for treatment. The current method of confirmation for correct NG tube placement is by aspirating (sucking out) gastric content from the tube and checking the pH level using pH strips. This is a painless process that is done routinely by the nurses. The same aspirate will be used to impregnate the novel lipase/pH test strip. The second phase of the clinical trial involves endotracheal (ET) tube testing. Patients who have ET tubes as part of their routine clinical management will be invited to the trial. Lung fluid is aspirated from the ET tube and tested on the new lipase/pH test strip. This process is to ensure that the novel lipase/pH strip is able to determine incorrect lung placement of NG tubes.
What are the possible benefits and risks of participating?
Participating in the clinical trial is voluntary and patients do not receive payment of any kind. There are no direct benefits for patients participating in the study. The procedures involved are part of routine management and do not affect their care and treatment. However, through their participation, they will be helping in the development of a new generation of pH strips that are safer and easier to use. These new strips have the potential to improve patient care. There are no notable risks to the patients having surgery.
Where is the study run from?
St Mary's Hospital and nine other NHS hospitals in England (UK)
When is the study starting and how long is it expected to run for?
October 2016 to July 2018
Who is funding the study?
Innovate UK (UK)
Who is the main contact?
1. Melody Ni
z.ni@imperial.ac.uk
2. Fatima Akbar
f.akbar@imperial.ac.uk
Contact information
Scientific
10th Floor QEQM Building
St. Mary's Hospital
South Wharf Road
London
W2 1NY
United Kingdom
| Phone | +44 (0)20 3312 6532 |
|---|---|
| z.ni@imperial.ac.uk |
Public
10th Floor QEQM Building
St. Mary's Hospital
South Wharf Road
London
W2 1NY
United Kingdom
| Phone | +44 (0)203 3126532 |
|---|---|
| f.akbar@imperial.ac.uk |
Study information
| Study design | Observational cross-sectional multi-centre diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN11170249_PIS_23Oct16_v9_ET.docx |
| Scientific title | A diagnostic accuracy study to evaluate a point-of-care lipase/pH test strip to confirm correct nasogastric tube position |
| Study hypothesis | The novel lipase/pH test is better than the standard pH strips used to confirm locations of blindly inserted nasogastric feeding tubes. |
| Ethics approval(s) | London - Chelsea Research Ethics Committee, 30/09/2016, ref: 16/LO/0998 |
| Condition | Patients with nasogastric tube in place for purpose of feeding and/or medication |
| Intervention | The study will be undertaken in two phases: Phase 1 - Diagnostic accuracy study The gold standard (reference test) will be chest x-ray if undertaken or if not required the initiation of nasogastric feeding will determine correct placement. Patients who have nasogastric tube inserted for supplementary feeding or medications will be recruited to the study. They will have aspirates taken after initial insertion or before each use of the nasogastric tube for confirmation of correct placement, which is part of the routine management. The gastric aspirate that has been acquired by the ward staff for their routine testing will be utilised by being passed to a member of the research team to be used in the study. Therefore, the results of the study will not influence patient care. The results for both the enzymatic test and pH test will be compared to the reference test and recorded. Phase 2 - A study to ensure that the test is able to determine incorrect lung placement of nasogastric tubes. Patients undergoing routine general anaesthesia will be invited to participate. These patients have endotracheal tubes placed as part of their routine management. Techniques including capnography will be used to confirm that these tubes are correctly placed in the lung. These will be aspirated and used with the novel enzymatic test to ensure a negative result in the case of lung intubation. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Impregnated pH strips |
| Primary outcome measure | Sensitivity of the index test and the reference tests (standard pH test) under cut-off 5.5 with tube sites confirmed by either patient follow up or chest x-rays when applicable. |
| Secondary outcome measures | 1. Percentage unable to aspirate is measured by the number of patients for whom no aspirate is obtained out of the total number of patients for whom the attempts have been made before either successful aspiration or before chest x-rays has to be requested 2. Number of chest radiographs requested is recorded exactly as described, when aspirates and re-attempts both fail |
| Overall study start date | 27/10/2016 |
| Overall study end date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 145 |
| Total final enrolment | 396 |
| Participant inclusion criteria | 1. Patients who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their clinical management 2. Aged 18 years old and over |
| Participant exclusion criteria | 1. Under the age of 18 years 2. Unable to sign consent 3. Not providing consent - updated 01/02/2019: Patients who lack capacity 4. Prisoners 5. Patients sectioned under the Mental Health Act |
| Recruitment start date | 14/12/2016 |
| Recruitment end date | 30/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Praed Street
London
W2 1NY
United Kingdom
Union Walk
Hereford
HR1 2ER
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Chichester House
Barnstaple
EX31 4JB
United Kingdom
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
Manchester
M13 9WL
United Kingdom
Southampton
SO16 6YD
United Kingdom
Room 47, E Floor, Butterfield
Romsey Road
Winchester
SO22 5DG
United Kingdom
Sponsor information
University/education
Joint Research Compliance Office
Charing Cross Hospital
London
W6 8RF
England
United Kingdom
| Phone | +44 (0)20 7594 9459 |
|---|---|
| r.nicholson@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the clinical study and the economic analysis that will be carried out based on the trial data and the human factors work package. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Melody Ni (z.ni@imperial.ac.uk) and Fatima Akbar (f.akbar@imperial.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v9 | 23/10/2016 | 21/06/2017 | No | Yes |
| Participant information sheet | version v8 | 23/10/2016 | 21/06/2017 | No | Yes |
| Results article | results | 04/11/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Pre-results | 04/11/2017 | 11/07/2023 | Yes | No |
| Results article | Development and validation | 14/12/2021 | 11/07/2023 | Yes | No |
Additional files
- ISRCTN11170249_PIS_23Oct16_v9_ET.docx
- Uploaded 21/06/2017
- ISRCTN11170249_PIS_23Oct16_v8_NT.docx
- Uploaded 21/06/2017
Editorial Notes
11/07/2023: Two publication references and total final enrolment added.
01/02/2019: The following changes were made to the trial record:
1. The contact details were updated.
2. The overall trial start date was changed from 01/05/2015 to 27/10/2016.
3. The recruitment start date was changed from 01/06/2017 to 14/12/2016.
4. The recruitment end date was changed from 31/12/2017 to 30/04/2018.
5. The overall trial end date was changed from 31/05/2018 to 31/07/2018.
6. The intention to publish date was changed from 31/12/2018 to 31/10/2019.
7. The target number of participants was changed from 550 to 145.
8. The exclusion criteria were updated.
9. Torbay Hospital was removed and Manchester University NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust and Royal Hampshire County Hospital were added to the trial participating centres.
06/11/2017: Publication reference added.
