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

Malnutrition Clinical Trial

Official title:

Nutrition Monitoring and Feeding Optimization With the smART+ System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098224
• Other study ID #: CRO-C-2822
• Status: Completed
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: February 24, 2022

Study information

• Verified date: October 2021
• Source: ART Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Malnutrition
• Pneumonia, Aspiration

Intervention

Device:
• smART+ System
Utilizing the smART+ System to provide feeding optimization to the patient

Locations

Country	Name	City	State
Israel	Beilinson Hospital	Petah Tikva	Isreal

Sponsors (1)

Lead Sponsor	Collaborator
ART Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Decrease in ICU length of stay	Measured from admission to ICU until the decision to discharge is ordered.	2 days-14 days
Secondary	Reduction of VAE (Ventilation Associated Events)	According to the definition from the latest CDC	2 days-14 days
Secondary	Decrease in ventilation days	Evaluated by the number of hours of etCO2 from the hospital electronic records	2 days-14 days
Secondary	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
Secondary	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
Secondary	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