Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
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|ClinicalTrials.gov Identifier: NCT04098224|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : June 4, 2020
The smART+ is a comprehensive modular patient care system intended for ICU patients.
The main purpose of the study is the optimization of the delivery of nutrition.
The use of the smART+ Feeding tube includes a feature of facilitating correct tube placement and alerting when the tube is displaced during ongoing use. The system will automatically stop feeding if displacement is detected. If a massive reflux episode is detected by the system, a balloon located on the tube will automatically inflate and automatic GRV feature will open to prevent gastric content from regurgitating to the esophagus.
In addition to tube placement, the system allows to obtain REE (Resting Energy Expenditure) measurements and calculates the optimized nutritional values required by the patient. Furthermore, the system optimizes feeding by compensating for any lost feeding time or discarded nutritional content that was discarded via the GRV (Gastric Residual Volume).
Study participants will be randomly assigned to a study group:
Group A- ICU patients receiving the investigational device ("Treated"). Group B- Control group.
|Condition or disease||Intervention/treatment||Phase|
|Aspiration Pneumonia Malnutrition||Device: smART+ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nutrition Monitoring and Feeding Optimization With the smART+ System|
|Actual Study Start Date :||January 12, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2022|
|Experimental: Interventional Device - Treated||
Device: smART+ System
Utilizing the smART+ System to provide feeding optimization to the patient
|No Intervention: Control Group|
- Nutrition optimization [ Time Frame: 2 days-14 days ]Optimization of the delivery of nutrition by the smART+ System as compared to standard of care, by automatically calculating and administering enteral feeding better than standard of care (REE or Calorimeter).
- Device Safety according to occurrence or absence of related AE or SAE [ Time Frame: 2 days-14 days ]Safe use of the entire system will be assessed based on the occurrence of device-related AE or SAE.
- Decrease in ICU length of stay [ Time Frame: 2 days-14 days ]Measured from admission to ICU until the decision to discharge is ordered.
- Reduction of VAE (Ventilation Associated Events) [ Time Frame: 2 days-14 days ]According to the definition from the latest CDC
- Decrease in ventilation days [ Time Frame: 2 days-14 days ]Evaluated by the number of hours of etCO2 from the hospital electronic records
- Decrease in workload related to nurse GRV time [ Time Frame: 2 days-14 days ]the change in workload could be estimated by using the estimated nursing time that was expended for GRV activities, and the amounts of GRV removed from the patient obtained through the hospital's electronic records and also the usability questionnaires
- Assessment of urine flow monitoring related to patient condition [ Time Frame: 2 days-14 days ]Patient lab results obtained through the hospital's electronic records will be analyzed against smART+ system urine alerts to determine if the alerts will be useful in the diagnosis
- Convenience of use of the system and the user interface (by subjective staff questionnaire) [ Time Frame: Through study completion in each site, an average of 1 year ]Evaluated via questionnaires filled by physician users and nurse users participating in the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098224
|Contact: Vera Dolgov||0508113604||Vera@artmedical.com|
|Petah Tikva, Isreal, Israel, 4941492|
|Contact: Ilya Kagan, MD 0504065483 Ilyak@clalit.org.il|
|Principal Investigator: Ilya Kagan, MD|
|Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel|
|Contact: Yael Haviv-Yadid, MD 03-5302748 Yael.Haviv@sheba.health.gov.il|
|Principal Investigator: Yael Haviv-Yadid, MD|
|Principal Investigator:||Ilya Kagan, MD||Beilinson Hospital|