Aspiration Pneumonia
Conditions
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.
Interventions
DEVICEsmARTrack Feeding Tube System
Sponsors
ART Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System automatically stops feeding when displacement is detected | 24-72 hours | The system automatically stops feeding when tube displacement is detected |
| Occurrence of device related Adverse Events (Safety) | 24-72 hours | Occurrence of device related adverse events |
| System is able to detect overfeeding | 24-72 hours | The system is able to detect overfeeding |
| System accurately guides correct initial placement | 24-72 hours | The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray) |
| System accurately detects tube movement/displacement during ongoing use | 24-72 hours | The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The system user interface is easy for use | 24-72 hours | Ease of use of the system and the user interface by subjective questionnaire of staff |
| Correlation of impedance detected to patient positioning | 24-72 hours | Recording of impedance detected by the system and correlation to patient positioning |
| Quantification of the amount of discarded nutritional supplement by implementing GRV test | 24-72 hours | Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures |
| Aspiration of gastric contents percentage compared to standard feeding (as reported in literature) | 24-72 hours | Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature). |
| Correlation between patient clinical information and the occurrence of reflux and sensors data | 24-72 hours | Correlation between patient clinical information and the occurrence of reflux and sensors data. |
Countries
Israel
Outcome results
None listed