Functionality and Accuracy of the smART System in Real-Life ICU Settings
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|ClinicalTrials.gov Identifier: NCT03689985|
Recruitment Status : Terminated (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)
First Posted : October 1, 2018
Last Update Posted : September 22, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Aspiration Pneumonia||Device: smART Feeding Tube System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functionality and Accuracy of the smART System in Real-Life ICU Settings|
|Actual Study Start Date :||November 7, 2018|
|Actual Primary Completion Date :||July 17, 2020|
|Actual Study Completion Date :||July 17, 2020|
One arm study: smART Feeding Tube System.
Device: smART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.
- Verify correct tube placement detection by the system [ Time Frame: 56 -168 hours ]To verify that the system is able to automatically detect correct tube placement during on-going use. By using an X-ray.
- Verify correct tube movement detection by the system [ Time Frame: 56 -168 hours ]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.
- Impedance levels [ Time Frame: 56 -168 hours ]To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.
- Stop feeding [ Time Frame: 56 -168 hours ]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.
- Clinical staff feedback by using a scale from 1 to 5 [ Time Frame: 56 -168 hours ]
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.
- Reflux episodes in relation to patient position [ Time Frame: 56 -168 hours ]To Collect data regarding the occurrence of reflux episodes in relation to patient positioning.
- Discarded nutritional supplement [ Time Frame: 56 -168 hours ]To quantify the amount of discarded nutritional supplement.
- No damage to esophagus tissue [ Time Frame: 56 -168 hours ]To evaluate the esophagus tissue for any damage caused by the smART system by means of performing an endoscopic examination after removing the device.
- Aspiration of gastric contents by monitoring the contents of the endotracheal tube suction [ Time Frame: 56 -168 hours ]To evaluate the effectiveness of the System to reduce aspiration of gastric contents. By monitoring the contents of the endotracheal tube suction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689985
|Petah Tikva, Isreal, Israel, 4941492|
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Yael Haviv-Yadid, Dr.||Sheba Medical Center|
|Principal Investigator:||Pierre Singer, Prof.||Belinson Hospital|