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

Aspiration Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03689985
• Other study ID #: CRO-B-2479
• Status: Terminated
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: July 17, 2020

Study information

• Verified date: September 2020
• Source: ART Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• smART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.

Locations

Country	Name	City	State
Israel	Belinson Hospital	Petah Tikva	Isreal
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
ART Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verify correct tube placement detection by the system	To verify that the system is able to automatically detect correct tube placement during on-going use. By using an X-ray.	56 -168 hours
Primary	Verify correct tube movement detection by the system	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.	56 -168 hours
Secondary	Impedance levels	To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.	56 -168 hours
Secondary	Stop feeding	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.	56 -168 hours
Secondary	Clinical staff feedback by using a scale from 1 to 5	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.	56 -168 hours
Secondary	Reflux episodes in relation to patient position	To Collect data regarding the occurrence of reflux episodes in relation to patient positioning.	56 -168 hours
Secondary	Discarded nutritional supplement	To quantify the amount of discarded nutritional supplement.	56 -168 hours
Secondary	No damage to esophagus tissue	To evaluate the esophagus tissue for any damage caused by the smART system by means of performing an endoscopic examination after removing the device.	56 -168 hours
Secondary	Aspiration of gastric contents by monitoring the contents of the endotracheal tube suction	To evaluate the effectiveness of the System to reduce aspiration of gastric contents. By monitoring the contents of the endotracheal tube suction.	56 -168 hours