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

Study Overview
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Brief Summary
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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).

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

Conditions
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Aspiration Pneumonia

Intervention / Treatment
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* Device: smART Feeding Tube System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General<br>One arm study: smART Feeding Tube System. | Device: smART Feeding Tube System<br>* Replacing generic feeding tube with smART Feeding Tube System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray |  | Enrollment visit | 
| Number of Tube Out of Position Alerts During Ongoing Use | Any patient , in which the system alerted of tube out of position , the staff verified this according to the tube markings and if mispositioning occurred, this was documented the event in the CRF out of position | Enrollment day up to 7 days | 
| Number of Automatic System Generated Feeding Stops in Response to Tube Displacement. | In order to prevent aspiration, the system software automatically pinches the feeding tube. Verification of the functionality of automatic feeding cessation when tube displacement is detected was done as part of the formal verification of the system | From insertion of feeding tube up to its removal , an average of 7 days. | 
| Number of Major Reflux Event That Lead to Automatically Stops Feeding | Overfeeding is the intolerance of the stomach to feeding material that causes reflux. There are two types of reflux events as defined by the system; minor-reflux and massive-reflux. Both types of reflux events are detected by the level of fluids interacting with the sensors, the severity is defined by gastric content reaching above the lower esophageal sphincter (LES): Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. Massive reflux is defined as gastric content that reaches immediately above the balloon. | From insertion of feeding tube up to its removal , an average of 7 days. | 
| Average Duration of Balloon Inflation in Response to a Reflux Episode. | Massive reflux of gastric content can aspirate into the lungs and cause pneumonia. The system detects the reflux event and will (according to an algorithm) stop the feeding and or inflate a balloon and evacuate gastric residuals from the stomach to lower the risk of aspiration. | From insertion of feeding tube up to its removal , an average of 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of Impedance Detected by the System and Correlation to Patient Positioning. | Positions changes were correlated to reflux events captured by the system console. Any position change of the patient was captured by the video camera located above the patient's bed. | From insertion of feeding tube up to its removal , an average of 7 days. | 
| Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents | The first and the last X-ray images obtained for patients during the study were used to evaluate Ventilator Associated Pneumonia (VAP) and/or Acute respiratory distress syndrome (ARDS) | 56 - 168 hours per patient |