Back to resultsNutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
Primary Purpose
Aspiration Pneumonia, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
smART+ System
Sponsored by
About this trial
This is an interventional other trial for Aspiration Pneumonia
Eligibility Criteria
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
Sites / Locations
- Beilinson Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional Device - Treated
Control Group
Arm Description
Subjects connected to the investigational device smART+
treated according to local Standard of Care.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Decrease in ICU length of stay
Measured from admission to ICU until the decision to discharge is ordered.
Reduction of VAE (Ventilation Associated Events)
According to the definition from the latest CDC
Decrease in ventilation days
Evaluated by the number of hours of etCO2 from the hospital electronic records
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04098224
Brief Title
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
Official Title
Nutrition Monitoring and Feeding Optimization With the smART+ System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ART Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia, Malnutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Device - Treated
Arm Type
Experimental
Arm Description
Subjects connected to the investigational device smART+
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
treated according to local Standard of Care.
Intervention Type
Device
Intervention Name(s)
smART+ System
Intervention Description
Utilizing the smART+ System to provide feeding optimization to the patient
Primary Outcome Measure Information:
Title
Nutrition optimization
Description
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).
Time Frame
2 days-14 days
Secondary Outcome Measure Information:
Title
Device Safety according to occurrence or absence of related AE or SAE
Description
Safe use of the entire system will be assessed based on the occurrence of device-related AE or SAE.
Time Frame
2 days-14 days
Title
Decrease in ICU length of stay
Description
Measured from admission to ICU until the decision to discharge is ordered.
Time Frame
2 days-14 days
Title
Reduction of VAE (Ventilation Associated Events)
Description
According to the definition from the latest CDC
Time Frame
2 days-14 days
Title
Decrease in ventilation days
Description
Evaluated by the number of hours of etCO2 from the hospital electronic records
Time Frame
2 days-14 days
Title
Decrease in workload related to nurse GRV time
Description
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
Time Frame
2 days-14 days
Title
Assessment of urine flow monitoring related to patient condition
Description
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
Time Frame
2 days-14 days
Title
Convenience of use of the system and the user interface (by subjective staff questionnaire)
Description
Evaluated via questionnaires filled by physician users and nurse users participating in the study
Time Frame
Through study completion in each site, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Kagan, MD
Organizational Affiliation
Beilinson Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beilinson Hospital
City
Petah Tikva
State/Province
Isreal
ZIP/Postal Code
4941492
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
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