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

Due to the company's intent to conduct a new study under a different protocol with the smART+ System which is a more advanced version of the smART System

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Sheba study site there were 2 participants and in the Jefferson study site (identifier NCT03198988) there were 8 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ 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 smART™ 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, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

To verify that the system is able to automatically detect correct tube placement during on-going use. By using an X-ray.

To verify that the system is able to automatically detect tube movement/displacement during on-going use. By comparing the data collected by the system sensors and the marking on the tube.

To verify that the system stops feeding when the tube is misplaced or reflux is detected by comparing the machine state to the nurses' logs.

Obtain feedback from clinical staff regarding device usability during use by using a questionnaire filled by the staff members. A Likert scale is used to asses usability of the device based on subjective user experience, where 1 represents negative response and 5 represents a positive response.

To evaluate the esophagus tissue for any damage caused by the smART system by means of performing an endoscopic examination after removing the device.

To evaluate the effectiveness of the System to reduce aspiration of gastric contents. By monitoring the contents of the endotracheal tube suction.

Inclusion Criteria: Males and females 18 years or older Patient has already been admitted to ICU Patient requires enteral feeding Patients receiving Proton Pump Inhibitors (PPI) therapy Informed consent by independent physician and next of kin ICU ventilated patients Exclusion Criteria: Patients with anomalies or diseases of the esophagus and or stomach. Patients with known sensitivities or allergies to any of the feeding tube materials Inability to place patient in 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)