Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study

Study Overview
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Brief Summary
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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.

Official Title
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Nutrition Monitoring and Feeding Optimization With the smART+ System

Conditions
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Aspiration Pneumonia, Malnutrition

Intervention / Treatment
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* Device: smART+ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18 years or older Patient that have already been admitted to the ICU (no more than 48 hours before enrollment) Expected to be ventilated at least 48 hours after enrollments. Patient requires enteral feeding (by naso/oro-gastric feeding tube) Exclusion Criteria: Pregnant women Known anatomical anomalies of the nose, oral cavity esophagus or the stomach that may prevent/hinder the ability to insert the feeding tube

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Device - Treated<br>Subjects connected to the investigational device smART+ | Device: smART+ System<br>* Utilizing the smART+ System to provide feeding optimization to the patient<br>|
| No Intervention: Control Group<br>treated according to local Standard of Care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition optimization | 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). | 2 days-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety according to occurrence or absence of related AE or SAE | Safe use of the entire system will be assessed based on the occurrence of device-related AE or SAE. | 2 days-14 days | 
| Decrease in ICU length of stay | Measured from admission to ICU until the decision to discharge is ordered. | 2 days-14 days | 
| Reduction of VAE (Ventilation Associated Events) | According to the definition from the latest CDC | 2 days-14 days | 
| Decrease in ventilation days | Evaluated by the number of hours of etCO2 from the hospital electronic records | 2 days-14 days | 
| Decrease in workload related to nurse GRV time | 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 | 2 days-14 days | 
| Assessment of urine flow monitoring related to patient condition | 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 | 2 days-14 days | 
| Convenience of use of the system and the user interface (by subjective staff questionnaire) | Evaluated via questionnaires filled by physician users and nurse users participating in the study | Through study completion in each site, an average of 1 year |