Functionality and Accuracy of the smART System in Real-Life ICU Settings
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: General One arm study: smART Feeding Tube System. |
Device: smART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.
|
Outcome Measures
Primary Outcome Measures
- Verify correct tube placement detection by the system [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 [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.
Secondary Outcome Measures
- Impedance levels [56 -168 hours]
To record and analyze impedance levels in order to recognize reflux episodes, measured in ohm.
- Stop feeding [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 [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 [56 -168 hours]
To Collect data regarding the occurrence of reflux episodes in relation to patient positioning.
- Discarded nutritional supplement [56 -168 hours]
To quantify the amount of discarded nutritional supplement.
- No damage to esophagus tissue [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females 18 years or older
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Patient has already been admitted to ICU
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Patient requires enteral feeding
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Patients receiving Proton Pump Inhibitors (PPI) therapy
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Informed consent by independent physician and next of kin
-
ICU ventilated patients
Exclusion Criteria:
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Patients with anomalies or diseases of the esophagus and or stomach.
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Patients with known sensitivities or allergies to any of the feeding tube materials
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Inability to place patient in semi-Fowler's position.
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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)
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Pregnancy
-
Recent abdominal surgery (less than 30 days)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Belinson Hospital | Petah Tikva | Isreal | Israel | 4941492 |
| 2 | Sheba Medical Center | Ramat Gan | Israel |
Sponsors and Collaborators
- ART Medical Ltd.
Investigators
- Principal Investigator: Yael Haviv-Yadid, Dr., Sheba Medical Center
- Principal Investigator: Pierre Singer, Prof., Belinson Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRO-B-2479