Clinical trial NCT03198988: Functionality and Accuracy of the smART System in Real-Life ICU Settings
Official title: Functionality and Accuracy of the smART System in Real-Life ICU Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Aspiration Pneumonia
Lead sponsor: ART Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray
timeFrame: Enrollment visit
measure: Number of Tube "Out of Position" Alerts During Ongoing Use
timeFrame: Enrollment day up to 7 days
measure: Number of Automatic System Generated Feeding Stops in Response to Tube Displacement.
timeFrame: From insertion of feeding tube up to its removal , an average of 7 days.
measure: Number of Major Reflux Event That Lead to Automatically Stops Feeding
timeFrame: From insertion of feeding tube up to its removal , an average of 7 days.
measure: Average Duration of Balloon Inflation in Response to a Reflux Episode.
timeFrame: From insertion of feeding tube up to its removal , an average of 7 days.
Secondary outcomes:
measure: Recording of Impedance Detected by the System and Correlation to Patient Positioning.
timeFrame: From insertion of feeding tube up to its removal , an average of 7 days.
measure: 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
timeFrame: 56 - 168 hours per patient
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: