Aspiration Pneumonia
Conditions
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).
Interventions
DEVICEsmART Feeding Tube System
Replacing generic feeding tube with smART Feeding Tube System.
Sponsors
ART Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tube Out of Position Alerts During Ongoing Use | Enrollment day up to 7 days | 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 Major Reflux Event That Lead to Automatically Stops Feeding | From insertion of feeding tube up to its removal , an average of 7 days. | 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): 1. Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. 2. Massive reflux is defined as gastric content that reaches immediately above the balloon. |
| Average Duration of Balloon Inflation in Response to a Reflux Episode. | From insertion of feeding tube up to its removal , an average of 7 days. | 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. |
| Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray | Enrollment visit | — |
| Number of Automatic System Generated Feeding Stops in Response to Tube Displacement. | From insertion of feeding tube up to its removal , an average of 7 days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 56 - 168 hours per patient | 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) |
| Recording of Impedance Detected by the System and Correlation to Patient Positioning. | From insertion of feeding tube up to its removal , an average of 7 days. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General One arm study: smART Feeding Tube System.
smART Feeding Tube System: Replacing generic feeding tube with smART Feeding Tube System. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | General |
|---|---|
| Age, Continuous | 53.62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Israel | 2 participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: From insertion of feeding tube up to its removal , an average of 7 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| General | Average Duration of Balloon Inflation in Response to a Reflux Episode. | 6.25 Minutes |
Primary
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
Time frame: From insertion of feeding tube up to its removal , an average of 7 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General | Number of Automatic System Generated Feeding Stops in Response to Tube Displacement. | 16 Number of stops of feeding |
Primary
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): 1. Minor reflux is defined as gastric content that did not pass the balloon located in the center of the esophagus. 2. 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.
Population: Each time the system detected massive reflux the system stop the feeding
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General | Number of Major Reflux Event That Lead to Automatically Stops Feeding | 709 Massive reflux episodes |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General | Number of Participants for Whom the System is Able to Accurately Guide and Ensure Correct Initial Feeding Tube Placement , Verified by X-ray | 9 Participants |
Primary
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
Time frame: Enrollment day up to 7 days
Population: Number of events that system is able to detect tube movement during the study period .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General | Number of Tube Out of Position Alerts During Ongoing Use | 16 Out of position alerts |
Secondary
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)
Time frame: 56 - 168 hours per patient
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General | 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 | No chance from first and last Xray images is seen | 2 Participants |
| General | 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 | Improvement in VAP/ARDS according to X-ray | 4 Participants |
| General | 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 | No VAP/ cannot be estimated | 3 Participants |
Secondary
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.
Time frame: From insertion of feeding tube up to its removal , an average of 7 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| General | Recording of Impedance Detected by the System and Correlation to Patient Positioning. | 46.19 position changes |