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Functionality and Accuracy of the smART System in Real-Life ICU Settings

Primary Purpose

Aspiration Pneumonia

Status
Terminated
Phase
Locations
United States
Study Type
Interventional
Intervention
smART Feeding Tube System
Sponsored by
ART Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aspiration Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females 18 years or older Patient has already been admitted to ICU Patient requires enteral feeding Patients receiving Proton Pump Inhibitors (PPI) therapy Informed consent by independent physician and next of kin ICU ventilated patients Exclusion Criteria: Patients with anomalies or diseases of the esophagus and or stomach. Patients with known sensitivities or allergies to any of the feeding tube materials Inability to place patient in semi-Fowler's position. Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder) Pregnancy Recent abdominal surgery (less than 30 days)

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

General

Arm Description

One arm study: smART Feeding Tube System.

Outcomes

Primary Outcome Measures

Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray
Number of Tube "Out of Position" Alerts During Ongoing Use
Any patient , in which the system alerted of tube out of position , the staff verified this according to the tube markings and if mispositioning occurred, this was documented the event in the CRF "out of position"
Number of Automatic System Generated Feeding Stops in Response to Tube Displacement.
In order to prevent aspiration, the system software automatically pinches the feeding tube. Verification of the functionality of automatic feeding cessation when tube displacement is detected was done as part of the formal verification of the system
Number of Major Reflux Event That Lead to Automatically Stops Feeding
Overfeeding is the intolerance of the stomach to feeding material that causes reflux. There are two types of reflux events as defined by the system; minor-reflux and massive-reflux. Both types of reflux events are detected by the level of fluids interacting with the sensors, the severity is defined by gastric content reaching above the lower esophageal sphincter (LES): Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. Massive reflux is defined as gastric content that reaches immediately above the balloon.
Average Duration of Balloon Inflation in Response to a Reflux Episode.
Massive reflux of gastric content can aspirate into the lungs and cause pneumonia. The system detects the reflux event and will (according to an algorithm) stop the feeding and or inflate a balloon and evacuate gastric residuals from the stomach to lower the risk of aspiration.

Secondary Outcome Measures

Recording of Impedance Detected by the System and Correlation to Patient Positioning.
Positions changes were correlated to reflux events captured by the system console. Any position change of the patient was captured by the video camera located above the patient's bed.
Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents
The first and the last X-ray images obtained for patients during the study were used to evaluate Ventilator Associated Pneumonia (VAP) and/or Acute respiratory distress syndrome (ARDS)

Full Information

First Posted
June 12, 2017
Last Updated
January 17, 2023
Sponsor
ART Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03198988
Brief Title
Functionality and Accuracy of the smART System in Real-Life ICU Settings
Official Title
Functionality and Accuracy of the smART System in Real-Life ICU Settings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the company's intent to conduct a new study under a different protocol with the smART+ System which is a more advanced version of the smART System.
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ART Medical Ltd.

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia

7. Study Design

Primary Purpose
Prevention
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General
Arm Type
Experimental
Arm Description
One arm study: smART Feeding Tube System.
Intervention Type
Device
Intervention Name(s)
smART Feeding Tube System
Intervention Description
Replacing generic feeding tube with smART Feeding Tube System.
Primary Outcome Measure Information:
Title
Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray
Time Frame
Enrollment visit
Title
Number of Tube "Out of Position" Alerts During Ongoing Use
Description
Any patient , in which the system alerted of tube out of position , the staff verified this according to the tube markings and if mispositioning occurred, this was documented the event in the CRF "out of position"
Time Frame
Enrollment day up to 7 days
Title
Number of Automatic System Generated Feeding Stops in Response to Tube Displacement.
Description
In order to prevent aspiration, the system software automatically pinches the feeding tube. Verification of the functionality of automatic feeding cessation when tube displacement is detected was done as part of the formal verification of the system
Time Frame
From insertion of feeding tube up to its removal , an average of 7 days.
Title
Number of Major Reflux Event That Lead to Automatically Stops Feeding
Description
Overfeeding is the intolerance of the stomach to feeding material that causes reflux. There are two types of reflux events as defined by the system; minor-reflux and massive-reflux. Both types of reflux events are detected by the level of fluids interacting with the sensors, the severity is defined by gastric content reaching above the lower esophageal sphincter (LES): Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. Massive reflux is defined as gastric content that reaches immediately above the balloon.
Time Frame
From insertion of feeding tube up to its removal , an average of 7 days.
Title
Average Duration of Balloon Inflation in Response to a Reflux Episode.
Description
Massive reflux of gastric content can aspirate into the lungs and cause pneumonia. The system detects the reflux event and will (according to an algorithm) stop the feeding and or inflate a balloon and evacuate gastric residuals from the stomach to lower the risk of aspiration.
Time Frame
From insertion of feeding tube up to its removal , an average of 7 days.
Secondary Outcome Measure Information:
Title
Recording of Impedance Detected by the System and Correlation to Patient Positioning.
Description
Positions changes were correlated to reflux events captured by the system console. Any position change of the patient was captured by the video camera located above the patient's bed.
Time Frame
From insertion of feeding tube up to its removal , an average of 7 days.
Title
Number of Participant With Change in Ventilator Associated Pneumonia (VAP) and/or Acute Respiratory Distress Syndrome (ARDS) as a Measure of Effectiveness in Reducing Aspiration of Gastric Contents
Description
The first and the last X-ray images obtained for patients during the study were used to evaluate Ventilator Associated Pneumonia (VAP) and/or Acute respiratory distress syndrome (ARDS)
Time Frame
56 - 168 hours per patient

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 has already been admitted to ICU Patient requires enteral feeding Patients receiving Proton Pump Inhibitors (PPI) therapy Informed consent by independent physician and next of kin ICU ventilated patients Exclusion Criteria: Patients with anomalies or diseases of the esophagus and or stomach. Patients with known sensitivities or allergies to any of the feeding tube materials Inability to place patient in semi-Fowler's position. Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder) Pregnancy Recent abdominal surgery (less than 30 days)
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Functionality and Accuracy of the smART System in Real-Life ICU Settings

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