Nasogastric Tube Placement
Conditions
Brief summary
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Interventions
DEVICENasotrak System
Device: The Nasotrak System The Nasotrak Medical System is intended to aid, in conjunction with institutional protocols, qualified operators in the placement of the Nasotrak's 12 Fr feeding tube into the stomach of patients requiring enteral feeding after insertion and before every feed. The Nasotrak nasogastric tube(NGT) is designed for use with Nasotrak's handheld device (HHD) which is able to detect the tip of the NGT via piezoelectric sensor, which converts ultrasound waves to electronic signals, thus assisting to track its location as an indicator of placement in the stomach. Nasotrak's NGT is intended only to be used with Nasotrak's HHD. The Nasotrak NGT is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
Sponsors
Nasotrak Medical Pte Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults greater than 18 years of age * Able to provide informed consent or have a legally authorized representative available to provide informed consent in English * Clinically requiring a 12 Fr NG/OG tube with X-ray confirmation per standard protocol
Exclusion criteria
* Female subjects of childbearing age with known pregnancy or lactating. * Prisoners. * Unable to consent in English. * Subjects/ volunteers with pacemakers or life-sustaining devices in the body such as ICD. * Subjects with a history of: * Esophageal varices or ulcers. * Upper airway obstruction. * Upper GI stenosis or obstruction. * Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion. * Deformities of the sinus cavities and/or skull base. * Esophageal cancer or neoplasm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray. | 1 year | All patients will receive placement verification per institutional practice |
Countries
United States
Contacts
Primary ContactDavid Tan
Outcome results
None listed