Using Magnetic Field Tracking to Confirm Nasogastric Tube Placement at Point of Care

NCT05204901 | Completed DMC

• 1 other identifier: DSRB 2021/00435
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a trial on the feasibility of magnetic tracking for the confirmation of nasogastric tube location in human patients.

Conditions

Enteral and Supplement Feeds Adverse Reaction; Gastrointestinal Diseases; Esophagus Disorder

Keywords

nasogastric tube; chest X-ray; confirmation of placement; magnetic tracking

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (2)

• test-retest variability

  6 months

• Adverse events related to the device

  6 months

Study Arms (1)

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.

Device: Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position

Interventions

Insertion and withdrawal of a magnetic-tipped wire into the lumen of the nasogastric tube for tracking of its position DEVICE

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investigator will place sensors on two sites of the sternum and track the location of the magnet as it is inserted and withdrawn from the nasogastric tube in the patients.

Magnetic tracking

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator
• Woodlands Health Campus: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (2)

• 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.

  PMID: 34209176 RESULT

• Li 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.

  PMID: 38528059 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Esophageal Diseases

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 24, 2022
• Study Start: May 4, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

SG (1)