Aspiration Pneumonia Clinical Trial
Official title:
Functionality and Accuracy of the smART System in Real-Life ICU Settings
Verified date | September 2020 |
Source | ART Medical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Israel | Belinson Hospital | Petah Tikva | Isreal |
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
ART Medical Ltd. |
Israel,
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 |
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