Tan Tock Seng Hospital
Singapore, 308433
NCT Number: NCT05204901
This is a trial on the feasibility of magnetic tracking for the confirmation of nasogastric tube location in human patients.
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Notify Me21 year–99 year
All sexes
Interventional
Not applicable
Singapore, 308433
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Tan Tock Seng Hospital
Other
Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care, A Feasibility Study
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