Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Study Overview
=================
Brief Summary
-----------------
This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.

Official Title
-----------------
Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Conditions
-----------------
Aspiration Pneumonia

Intervention / Treatment
-----------------
* Device: smARTrack Feeding Tube System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 18 years or older Patient has already been admitted to ICU Patient requires enteral feeding Patients receiving PPI therapy Informed consent by independent physician and next of kin ICU ventilated patients Exclusion Criteria: Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach. Patients with known sensitivities or allergies to any of the feeding tube materials Inability to place patient is semi-Fowler's position. Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder) Pregnancy Recent abdominal surgery (less than 30 days)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General<br>One arm study: smARTrack Feeding Tube System. | Device: smARTrack Feeding Tube System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System accurately guides correct initial placement | The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray) | 24-72 hours | 
| System accurately detects tube movement/displacement during ongoing use | The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube) | 24-72 hours | 
| System automatically stops feeding when displacement is detected | The system automatically stops feeding when tube displacement is detected | 24-72 hours | 
| System is able to detect overfeeding | The system is able to detect overfeeding | 24-72 hours | 
| Occurrence of device related Adverse Events (Safety) | Occurrence of device related adverse events | 24-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The system user interface is easy for use | Ease of use of the system and the user interface by subjective questionnaire of staff | 24-72 hours | 
| Correlation of impedance detected to patient positioning | Recording of impedance detected by the system and correlation to patient positioning | 24-72 hours | 
| Quantification of the amount of discarded nutritional supplement by implementing GRV test | Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures | 24-72 hours | 
| Aspiration of gastric contents percentage compared to standard feeding (as reported in literature) | Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature). | 24-72 hours | 
| Correlation between patient clinical information and the occurrence of reflux and sensors data | Correlation between patient clinical information and the occurrence of reflux and sensors data. | 24-72 hours |