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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098224
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
ART Medical Ltd.

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.


Condition or disease Intervention/treatment Phase
Aspiration Pneumonia Malnutrition Device: smART+ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: Interventional Device - Treated Device: smART+ System
Utilizing the smART+ System to provide feeding optimization to the patient

No Intervention: Control Group



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Decrease in ICU length of stay [ Time Frame: 2 days-14 days ]
    Measured from admission to ICU until the decision to discharge is ordered.

  3. Reduction of VAE (Ventilation Associated Events) [ Time Frame: 2 days-14 days ]
    According to the definition from the latest CDC

  4. Decrease in ventilation days [ Time Frame: 2 days-14 days ]
    Evaluated by the number of hours of etCO2 from the hospital electronic records

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098224


Contacts
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Contact: Vera Dolgov 0508113604 Vera@artmedical.com

Locations
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Israel
Beilinson Hospital Recruiting
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         
Sponsors and Collaborators
ART Medical Ltd.
Investigators
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Principal Investigator: Ilya Kagan, MD Beilinson Hospital
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Responsible Party: ART Medical Ltd.
ClinicalTrials.gov Identifier: NCT04098224    
Other Study ID Numbers: CRO-C-2845
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Malnutrition
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Nutrition Disorders