Clinical trial NCT02705781: Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
Official title: Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration Pneumonia
Lead sponsor: ART Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 20
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: System accurately guides correct initial placement
timeFrame: 24-72 hours
measure: System accurately detects tube movement/displacement during ongoing use
timeFrame: 24-72 hours
measure: System automatically stops feeding when displacement is detected
timeFrame: 24-72 hours
measure: System is able to detect overfeeding
timeFrame: 24-72 hours
measure: Occurrence of device related Adverse Events (Safety)
timeFrame: 24-72 hours
Secondary outcomes:
measure: The system user interface is easy for use
timeFrame: 24-72 hours
measure: Correlation of impedance detected to patient positioning
timeFrame: 24-72 hours
measure: Quantification of the amount of discarded nutritional supplement by implementing GRV test
timeFrame: 24-72 hours
measure: Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)
timeFrame: 24-72 hours
measure: Correlation between patient clinical information and the occurrence of reflux and sensors data
timeFrame: 24-72 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References: