Trial Outcomes & Findings for Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study (NCT NCT04098224)

Last Updated: 2025-05-29

Results Overview

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). The primary endpoint was the average feeding deviation between Days 2-14. Feeding deviation percentage was defined as the percentage of deviation from the nutrition target, calculated as the absolute value of 100 X (volume of nutrition delivered (mL) / the volume intended to be delivered (VTBD; mL))

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

2 days-14 days

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Interventional Device - Treated Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group treated according to local Standard of Care.
Overall Study STARTED	50	50
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Interventional Device - Treated Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group treated according to local Standard of Care.
Overall Study Adverse Event	1	0
Overall Study Physician Decision	1	0
Overall Study Patient not required enteral feeding	1	0
Overall Study Patient failure nasogastric tube	1	0
Overall Study Patient early extubation	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.	Total n=100 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 17.5 • n=99 Participants	62.1 years STANDARD_DEVIATION 16.0 • n=107 Participants	60.7 years STANDARD_DEVIATION 16.7 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	16 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	39 Participants n=99 Participants	34 Participants n=107 Participants	73 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	50 Participants n=99 Participants	50 Participants n=107 Participants	100 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Israel	50 participants n=99 Participants	50 participants n=107 Participants	100 participants n=206 Participants
BMI body mass index	29.2 KG/M^2 STANDARD_DEVIATION 7.3 • n=99 Participants	29.5 KG/M^2 STANDARD_DEVIATION 8.8 • n=107 Participants	29.3 KG/M^2 STANDARD_DEVIATION 8.1 • n=206 Participants
APACHE II Acute Physiology and Chronic Healthy Evaluation II	22.4 units on a scale STANDARD_DEVIATION 6.9 • n=99 Participants	22.3 units on a scale STANDARD_DEVIATION 7.0 • n=107 Participants	22.4 units on a scale STANDARD_DEVIATION 6.9 • n=206 Participants
Time to Intensive Care Unit administration	24.5 Hours STANDARD_DEVIATION 11.7 • n=99 Participants	28.3 Hours STANDARD_DEVIATION 11.4 • n=107 Participants	26.4 Hours STANDARD_DEVIATION 11.6 • n=206 Participants

PRIMARY outcome

Timeframe: 2 days-14 days

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=48 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Nutrition Optimization	89.5 percentage of feeding efficiency Standard Deviation 13.0	65 percentage of feeding efficiency Standard Deviation 18.0

SECONDARY outcome

Timeframe: 2 days-14 days

Safe use of the entire system will be assessed based on the occurrence of device-related AE adverse event or SAE Serious Adverse Events.

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events Adverse event related to device	0 Participants	0 Participants
Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events Death not related to device	3 Participants	3 Participants

SECONDARY outcome

Timeframe: from admission to discharge from ICU ('ICU length of stay')

Measured from admission to Intensive Critical Unit until the decision to discharge is ordered.

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Decrease in Intensive Critical Unit Length of Stay	10.37 Days Standard Deviation 7.01	13.65 Days Standard Deviation 9.16

SECONDARY outcome

Timeframe: 2 days-14 days

Ventilated associated events (VAE) was evaluated by modifications of FIO2 fraction of inspired oxygen (above .2) or PEEP Positive end-expiratory pressure (above 3 cm H20) requirements that were longer than 48 hours \[per the CDC Centers for Disease Control and Prevention definition and clinical judgment of the interpreting physician\]

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Reduction of Number of Patients With VAE (Ventilation Associated Events)	1 Participants	5 Participants

SECONDARY outcome

Timeframe: from admission to discharge from ICU ('ICU length of stay') up to 14 days.

Evaluated by the number of hours of End-tidal CO2 from the hospital electronic records

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Decrease in ICU Ventilation Days	9.52 Days Standard Deviation 7.32	12.78 Days Standard Deviation 8.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interventional Device - Treated n=50 Participants Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 Participants treated according to local Standard of Care.
Decrease in Workload Related to Nurse Gastric Residual Volume (GRV) Time Daily total amount of GRV [ml/day]	124.25 ml/day Interval 100.03 to 148.46	166.10 ml/day Interval 145.93 to 186.27
Decrease in Workload Related to Nurse Gastric Residual Volume (GRV) Time Max GRV per event in one day [ml/d]	33.3941 ml/day Interval 18.8106 to 47.9777	114.95 ml/day Interval 102.82 to 127.08

SECONDARY outcome

Timeframe: 2 days-14 days

Population: In order to assess this endpoint a larger sample size is required. This secondary endpoint was omitted from the study because the study enrollment was stopped after the primary endpoint of feeding efficiency was achieved (100 patients enrolled).

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the study

Subjective staff questionnaire to be completed by all personnel involved in the study, to assess usability. In order to assess this endpoint a larger sample size is required. This secondary endpoint was omitted from the study because the study enrollment was stopped after the primary endpoint of feeding efficוency was achieved (100 patients enrolled).

Outcome measures

Outcome data not reported

Adverse Events

Interventional Device - Treated

Serious events: 3 serious events

Other events: 35 other events

Deaths: 3 deaths

Control Group

Serious events: 3 serious events

Other events: 39 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Interventional Device - Treated n=50 participants at risk Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 participants at risk treated according to local Standard of Care.
Respiratory, thoracic and mediastinal disorders Post COVID 19	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Cardiac disorders Desaturation	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Respiratory, thoracic and mediastinal disorders Respiratory and hemodynamic deterioration	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Infections and infestations Septic shock deterioration	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Respiratory, thoracic and mediastinal disorders Severe progressive hypoxemic and hemodynamic disorder	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .

Other adverse events

Additional Information

Mrs. Shirly Steinlauf

ART MEDICAL

Phone: 972-54-5804242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Interventional Device - Treated n=50 participants at risk Subjects connected to the investigational device smART+ smART+ System: Utilizing the smART+ System to provide feeding optimization to the patient	Control Group n=50 participants at risk treated according to local Standard of Care.
Infections and infestations New infection in blood	18.0% 9/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	22.0% 11/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Infections and infestations New infection in sputum	40.0% 20/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	46.0% 23/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Infections and infestations New infection in broncial lavage	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	14.0% 7/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Cardiac disorders Atrial fibralation	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	8.0% 4/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Cardiac disorders Bradycardia	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Cardiac disorders Tachycardia	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	6.0% 3/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Blood and lymphatic system disorders Low hemoglobin level	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	6.0% 3/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Product Issues Self nasogastric tube removal	6.0% 3/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders Hypomagnesemia	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders Fever	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders Pressure sores	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders High blood pressure	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders Lower blood pressure	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
General disorders Hypophosphatemia	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Metabolism and nutrition disorders Massive diarrhea	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Metabolism and nutrition disorders High GRV	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Respiratory, thoracic and mediastinal disorders Respiratory rate deterioration	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	4.0% 2/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Respiratory, thoracic and mediastinal disorders Pulmonary infiltate	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Ear and labyrinth disorders Left atelectasis	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Nervous system disorders Tonic clonic seizure	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .
Renal and urinary disorders Acute kidney injury	0.00% 0/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .	2.0% 1/50 • The adverse event for each patient was collected form the day of screening visit until the day of completing the study , totally 14 days .