Enteral and Supplement Feeds Adverse ReactionNCT05204901
Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care
A study testing Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position in people with Enteral and Supplement Feeds Adverse Reaction and Gastrointestinal Diseases, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This is a trial on the feasibility of magnetic tracking for the confirmation of nasogastric tube location in human patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Enteral and Supplement Feeds Adverse Reaction, Gastrointestinal Diseases, Esophagus Disorder
- What is being tested?
- Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 4 May 2022to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from the general ward or the Otorhinolaryngology clinic of Tan Tock Seng Hospital who had an NGT inserted within the last 10 days and chest X-ray confirming its correct placement
- The NGT inserted is a Ryles tube size Fr 14 or 16
- COVID negative or not deemed to be infective as judged by the prevailing policies at the time of recruitment
- Age > or = 21 years
- BMI < 35
- Height < 1.9m
- Mentally competent for informed consent
Who cannot join
- • Radiological:
- On chest X-ray, the length of the NGT distal to the gastroesophageal junction is less than 12cm, or the side-holes of the NGT can be visualized in the esophagus.
- The NGT is kinked within 10cm of its tip
- The chest X-ray is rotated such that the thorax is not oriented in the frontal plane
- The NGT cannot be visualized in the mediastinum
- The second intercostal space cannot be visualized on chest X-ray
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- Medically unstable:
- Heart rate >=100 or <60
- Systolic blood pressure >=160 or <100
- SpO2 <92% in patients with chronic lung disease and <95% in patients without chronic lung disease
- Temperature >= 38 degrees Celsius
- Chest wall deformity:
- Patients with pectus carinatum or excavatum, defined by physical examination
- Patients with the following implants
- Pacemaker
- Automatic cardioverter defibrillator
- Ferromagnetic coronary stents or heart valves
- Ferromagnetic implants of the cranium, face, spine, sternum or ribs
- Ferromagnetic surgical clips or implants in the head, neck, thorax, abdomen or pelvis
- Following conditions within the last 30 days
- Upper gastrointestinal bleeding
- Oesophageal or gastric surgery
- Stroke
- Myocardial infarction
- Aortic dissection
- Ruptured aortic aneurysm
- Allergy to neodymium, gold, epoxy or nitinol
- Not able to understand English, Chinese, Malay or Tamil
- Women whose last menstrual period commenced more than 4 weeks before recruitment unless they have a negative urinary or serum pregnancy test during their current admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care, A Feasibility Study
This is a trial on the feasibility of magnetic tracking for the confirmation of nasogastric tube location in human patients.
Read the detailed description
In order to address the clinical need for the localization of nasogastric tube (NGT) at point-of-care, Nanyang Technological University, Tan Tock Seng Hospital and Woodlands Health Campus co-developed the prototype of a medical device that consists of a guidewire attached to a gold-plated Neodymium magnet to be used with a T-shaped body-worn sensors connected to a laptop. The magnetic-tipped guidewire is compatible with 14Fr or larger Ryles tubes. The sensors are passive and are designed to fit on the patient's sternum beginning at the level of the second intercostal space or xiphisternum. These sensors can track the changes in magnetic flux density real-time as the magnetic-tipped guidewire is inserted into the lumen of an NGT. The tracking may be done during NGT insertion or before feeding if confirmation of its location is required. The changes in magnetic flux density will be used to determine the location of the magnet in relation to the sensors. The result of these computations will be displayed on the computer screen as a trajectory of the magnet's movement inside the NGT. At full insertion of the guidewire, the trajectory should correspond to the actual location of the NGT in the patient.
This device is currently not in use but the investigators have notified the Health Science Authority of Singapore for its use as a Clinical Research Material.
The investigators aim to recruit 12 adult patients from both gender (6 each) who would already have had NGT placement and confirmation of its position by CXR within 48 hours of NGT insertion. These patients may have a variety of body habitus and will be screened according to a detailed list of exclusion criteria that rules out a recent medical history of oesophageal or gastric surgery, cardiac stent, pacemaker, implantable defibrillator or ferromagnetic implants in the neck, thorax, abdomen, pelvis or spine.
The investigators plan to test the following hypotheses and safety parameters.
- Concordance of our tracking with the trajectory of the NGT seen on chest X-ray
- The vertical and horizontal range of tracking
- The ability to detect a leftward deviation from the midline inferior to the xiphisternum
- Test-retest reliability
- Adverse events related to the magnetic-tipped guidewire or the sensors
- Conditions
- Enteral and Supplement Feeds Adverse Reaction, Gastrointestinal Diseases, Esophagus Disorder
- Being tested
- Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position
- Keywords
- nasogastric tube, chest X-ray, confirmation of placement, magnetic tracking
- Medical subject headings
- Gastrointestinal Diseases, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its positionDevice
In each participant, the investigator will place sensors on two sites of the sternum and track the location of the magnet as it is inserted and withdrawn from the nasogastric tube in the patients.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic tracking | Experimental | This is the only arm of the study. All 12 participants will undergo the insertion of the magnetic-tipped guidewire into their nasogastric tube after its correct placement is confirmed by chest X-ray. Receives: Device: Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of visualising a leftward deviation of the magnetic tipped guide-wire inferior to the xiphisternum
The investigators will measure the rate of visualisation of a left-ward deviation of the magnet below the plane of xiphisternum in participants whose nasogastric tube deviates in such a way on chest X-ray.
Measured: 6 months
Difference in the distance between the magnet and the datum with that between the nasogastric tube on chest X-ray and the datum
The investigators will compare difference in distance (measured in millimetres) between the path of the nasogastric tube seen on magnetic tracking with that seen on chest X-ray by comparing them against a vertical midline (datum) centred over the midpoint of the sternum.
Measured: 6 months
Secondary outcomes (2)
test-retest variability
The investigators will compare the distance between the magnet and the datum at the insertion of the guide-wire against that obtained at withdrawal in order to determine the variation in the accuracy of the tracking with repeated testing.
Measured: 6 months
Adverse events related to the device
The investigators will record the incidence of magnet dislodgement, breakage of the guidewire, pain during insertion and withdrawal of the device, dermatitis over the chest wall in reaction to the sensors and any other unexpected adverse events caused by the device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start4 May 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral and Supplement Feeds Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University, Woodlands Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204901
- Sponsor's protocol ID
- DSRB 2021/00435
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized IPD may be shared with other researchers upon reasonable request.
Publications
Miyasaka M, Li H, Tay KV, Phee SJ. A Low-Cost, Point-of-Care Test for Confirmation of Nasogastric Tube Placement via Magnetic Field Tracking. Sensors (Basel). 2021 Jun 30;21(13):4491. doi: 10.3390/s21134491.
PubMed 34209176Li H, Tay KV, Liu J, Ong CYG, Khoo HW, Zhou A, Miyasaka M, Phee SJ. Feasibility of a low-cost magnet tracking device in confirming nasogastric tube placement at point of care, a clinical trial. Sci Rep. 2024 Mar 25;14(1):7068. doi: 10.1038/s41598-024-57455-7.
PubMed 38528059
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care, A Feasibility Study
- ClinicalTrials.gov ID
- NCT05204901
- Acronym / sponsor ID
- DSRB 2021/00435
- Conditions
- Enteral and Supplement Feeds Adverse Reaction, Gastrointestinal Diseases, Esophagus Disorder
- Keywords
- nasogastric tube, chest X-ray, confirmation of placement, magnetic tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University, Woodlands Hospital
- Study start
- 4 May 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial on the feasibility of magnetic tracking for the confirmation of nasogastric tube location in human patients.
Detailed description
In order to address the clinical need for the localization of nasogastric tube (NGT) at point-of-care, Nanyang Technological University, Tan Tock Seng Hospital and Woodlands Health Campus co-developed the prototype of a medical device that consists of a guidewire attached to a gold-plated Neodymium magnet to be used with a T-shaped body-worn sensors connected to a laptop. The magnetic-tipped guidewire is compatible with 14Fr or larger Ryles tubes. The sensors are passive and are designed to fit on the patient's sternum beginning at the level of the second intercostal space or xiphisternum. These sensors can track the changes in magnetic flux density real-time as the magnetic-tipped guidewire is inserted into the lumen of an NGT. The tracking may be done during NGT insertion or before feeding if confirmation of its location is required. The changes in magnetic flux density will be used to determine the location of the magnet in relation to the sensors. The result of these computations will be displayed on the computer screen as a trajectory of the magnet's movement inside the NGT. At full insertion of the guidewire, the trajectory should correspond to the actual location of the NGT in the patient.
This device is currently not in use but the investigators have notified the Health Science Authority of Singapore for its use as a Clinical Research Material.
The investigators aim to recruit 12 adult patients from both gender (6 each) who would already have had NGT placement and confirmation of its position by CXR within 48 hours of NGT insertion. These patients may have a variety of body habitus and will be screened according to a detailed list of exclusion criteria that rules out a recent medical history of oesophageal or gastric surgery, cardiac stent, pacemaker, implantable defibrillator or ferromagnetic implants in the neck, thorax, abdomen, pelvis or spine.
The investigators plan to test the following hypotheses and safety parameters.
- Concordance of our tracking with the trajectory of the NGT seen on chest X-ray
- The vertical and horizontal range of tracking
- The ability to detect a leftward deviation from the midline inferior to the xiphisternum
- Test-retest reliability
- Adverse events related to the magnetic-tipped guidewire or the sensors
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic tracking | Experimental | Device: Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its positionThis is the only arm of the study. All 12 participants will undergo the insertion of the magnetic-tipped guidewire into their nasogastric tube after its correct placement is confirmed by chest X-ray. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients from the general ward or the Otorhinolaryngology clinic of Tan Tock Seng Hospital who had an NGT inserted within the last 10 days and chest X-ray confirming its correct placement
- The NGT inserted is a Ryles tube size Fr 14 or 16
- COVID negative or not deemed to be infective as judged by the prevailing policies at the time of recruitment
- Age > or = 21 years
- BMI < 35
Key exclusion criteria (29 listed)
- • Radiological:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its positionIn each participant, the investigator will place sensors on two sites of the sternum and track the location of the magnet as it is inserted and withdrawn from the nasogastric tube in the patients. | Device | Magnetic tracking |
Primary outcome
Probability of visualising a leftward deviation of the magnetic tipped guide-wire inferior to the xiphisternum
Time frame: 6 months
The investigators will measure the rate of visualisation of a left-ward deviation of the magnet below the plane of xiphisternum in participants whose nasogastric tube deviates in such a way on chest X-ray.
Difference in the distance between the magnet and the datum with that between the nasogastric tube on chest X-ray and the datum
Time frame: 6 months
The investigators will compare difference in distance (measured in millimetres) between the path of the nasogastric tube seen on magnetic tracking with that seen on chest X-ray by comparing them against a vertical midline (datum) centred over the midpoint of the sternum.
2 secondary outcomes
test-retest variability
Time frame: 6 months
Adverse events related to the device
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Results publication: PubMed 34209176Miyasaka M, Li H, Tay KV, Phee SJ. A Low-Cost, Point-of-Care Test for Confirmation of Nasogastric Tube Placement via Magnetic Field Tracking. Sensors (Basel). 2021 Jun 30;21(13):4491. doi: 10.3390/s21134491.
- Derived from this study: PubMed 38528059Li H, Tay KV, Liu J, Ong CYG, Khoo HW, Zhou A, Miyasaka M, Phee SJ. Feasibility of a low-cost magnet tracking device in confirming nasogastric tube placement at point of care, a clinical trial. Sci Rep. 2024 Mar 25;14(1):7068. doi: 10.1038/s41598-024-57455-7.
- Individual participant dataSharing planned: Undecided. Anonymized IPD may be shared with other researchers upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position in people with Enteral and Supplement Feeds Adverse Reaction and Gastrointestinal Diseases, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of visualising a leftward deviation of the magnetic tipped guide-wire inferior to the xiphisternum (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.