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

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

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 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).

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)