Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care
Condition: Enteral and Supplement Feeds Adverse Reaction; Gastrointestinal Diseases; Esophagus Disorder
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Esophageal Diseases
Study type: Interventional

Summary: 
      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.

        1. Concordance of our tracking with the trajectory of the NGT seen on chest X-ray

        2. The vertical and horizontal range of tracking

        3. The ability to detect a leftward deviation from the midline inferior to the xiphisternum

        4. Test-retest reliability

        5. Adverse events related to the magnetic-tipped guidewire or the sensors
    

Intervention name(s): Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: nasogastric tube; chest X-ray; confirmation of placement; magnetic tracking