Enteral Nutrition
Conditions
Brief summary
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the ENVUE™ System guidance during the placement of the ENvizion Medical™ enteral feeding tubes.
Detailed description
Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings. It is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of Enteral Feeding Tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2- 4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients. The gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement. All the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position. The ENVUE™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement. The benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.
Interventions
DEVICEENVUE System
The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine.
Sponsors
Envizion Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be \>21 years of age * Patients must require placement of an enteral feeding tube * Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12) * Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent
Exclusion criteria
* Patients must not have a history of: * Esophageal varices or ulcers * Upper airway obstruction * Upper GI stenosis or obstruction * Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion * Deformities of the sinus cavities and/or skull base * Esophageal cancer or neoplasm * Patients must not have a significant concomitant illness that would adversely affect their participation in the study * Female patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successfully Placed Enteral Feeding Tube | During procedure visit | Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events. Procedure success was evaluated by comparing tube tip location according to the ENVUE System and abdominal and/or thoracic X-Ray. Guidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Placement Attempts | During procedure visit | Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: * Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion * Repositioning: Changing position of tube without complete removal of the tube |
| Number of Retrograde Tube Migration Events | During follow-up visit (20-48 hours post tube placement) | Tube Migration was defined as: Retrograde migration from desired placement position. |
Countries
United States
Participant flow
Pre-assignment details
Of 48 enrolled participants, 46 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 46 participants, 43 completed a successful tube placement.
Participants by arm
| Arm | Count |
|---|---|
| EFT Placement Using ENVUE System Placement of the ENvizion Medical™ Enteral Feeding Tube (EFT) in the stomach or small intestine of adult patients who require feedings via the oro/ nasoenteric route, using the ENVUE™ System.
ENVUE System: The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Anatomical abnormality | 1 |
| Overall Study | Died before procedure | 1 |
| Overall Study | Obstruction by Endotracheal tube | 1 |
| Overall Study | Unable to pass through esophagus | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | EFT Placement Using ENVUE System |
|---|---|
| Age, Continuous | 67 years |
| Endotracheal Tube | 38 Participants |
| Obtunded | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White | 40 Participants |
| Region of Enrollment United States | 43 participants |
| Sedated | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 48 |
| other Total, other adverse events | 1 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Number of Participants With Successfully Placed Enteral Feeding Tube
Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events. Procedure success was evaluated by comparing tube tip location according to the ENVUE System and abdominal and/or thoracic X-Ray. Guidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study.
Time frame: During procedure visit
Population: Subjects who underwent a successful feeding tube placement using the ENvue system
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EFT Placement Using ENVUE System | Number of Participants With Successfully Placed Enteral Feeding Tube | 43 Participants |
Secondary
Number of Retrograde Tube Migration Events
Tube Migration was defined as: Retrograde migration from desired placement position.
Time frame: During follow-up visit (20-48 hours post tube placement)
Population: 43 subjects underwent a successful feeding tube placement using the ENvue system.~Of the Forty- three (43) subjects that completed a successful placement procedure, thirty-six (36) subjects underwent a successful tube tip position check at follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFT Placement Using ENVUE System | Number of Retrograde Tube Migration Events | 3 Number of tube retrograde migration |
Secondary
Total Number of Placement Attempts
Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below: * Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion * Repositioning: Changing position of tube without complete removal of the tube
Time frame: During procedure visit
Population: 43 subjects underwent a successful feeding tube placement using the ENvue system. In total, 44 tubes were successfully placed- 1 subject pulled the tube out and a new tube was placed instead
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFT Placement Using ENVUE System | Total Number of Placement Attempts | 49 Number of placement attempts |