Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System

Not Applicable

Terminated

Conditions: Enteral Nutrition

Interventions: Device: Nutriplace™ System

Registration Number: NCT03371160

Lead Sponsor: Nutriseal L.P

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 22

Inclusion Criteria

Patients must be >21 years of age
Patients must require placement of a nasoenteral 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 Nasogastriv (NG) 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutriplace™ System	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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