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This study conducted in order to validate the functionality and accuracy of the smARTrackâ„¢ System in a real-life ICU setting. The smARTrackâ„¢ 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 smARTrackâ„¢ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrackâ„¢ 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 smARTrackâ„¢ 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, smARTrackâ„¢ Feeding Tube System can guide operator to correctly re-position the tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General | Experimental | One arm study: smARTrack Feeding Tube System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smARTrack Feeding Tube System | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 31096 | Israel |
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| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
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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 |
| D012140 |
| Respiratory Tract Diseases |