Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
- Conditions
- Aspiration Pneumonia
- Interventions
- Device: smARTrack Feeding Tube System
- Registration Number
- NCT02705781
- Lead Sponsor
- ART Medical Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description General smARTrack Feeding Tube System One arm study: smARTrack Feeding Tube System.
- Primary Outcome Measures
Name Time Method Occurrence of device related Adverse Events (Safety) 24-72 hours Occurrence of device related adverse events
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)
System automatically stops feeding when displacement is detected 24-72 hours The system automatically stops feeding when tube displacement is detected
System is able to detect overfeeding 24-72 hours The system is able to detect overfeeding
- Secondary Outcome Measures
Name Time Method 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.
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).
Trial Locations
- Locations (1)
Rambam Health Care Campus
🇮🇱Haifa, Israel