Enteral Nutrition
Conditions
Brief summary
This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the Nutriplace™ System guidance during the placement of the Nutriseal™ 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 Nutriplace™ 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
DEVICENutriplace™ System
The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.
Sponsors
Nutriseal L.P
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
1. Patients must be \>21 years of age 2. Patients must require placement of a nasoenteral feeding tube 3. 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) 4. 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
1. 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 Nasogastriv (NG) tube insertion * Deformities of the sinus cavities and/or skull base * Esophageal cancer or neoplasm 2. Patients must not have a significant concomitant illness that would adversely affect their participation in the study 3. 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 NUTRIPLACE 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 |
|---|---|---|
| Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube | 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 Participants Reporting Retrograde Tube Migration in the Follow-up Visit | 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
Participants by arm
| Arm | Count |
|---|---|
| Nutriplace™ System Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.
Nutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Nutriplace™ System |
|---|---|
| Age, Continuous | 62.5 years |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
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 NUTRIPLACE 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: Of 22 enrolled participants, 19 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 22 participants, 14 completed a successful tube placement using the ENvue system.~The study was halted pre-maturely due to a very low enrollment rate at the site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutriplace™ System | Number of Participants With Successfully Placed Enteral Feeding Tube | 14 Participants |
Secondary
Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit
Tube Migration was defined as: Retrograde migration from desired placement position
Time frame: During follow-up visit (20-48 hours post tube placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutriplace™ System | Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit | 1 Participants |
Secondary
Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutriplace™ System | Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube | 10 Participants |