Clinical trial NCT03505593: Feasibility Study to Evaluate Safety of ENvizion Medical™ ENVUE™ System
Official title: A Feasibility Study to Evaluate the Clinical Safety of ENvizion Medical™ Enteral Feeding Tube Placement Using the ENvizion Medical™ ENVUE™ System in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: Envizion Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successfully Placed Enteral Feeding Tube
timeFrame: During procedure visit
Secondary outcomes:
measure: Total Number of Placement Attempts
timeFrame: During procedure visit
measure: Number of Retrograde Tube Migration Events
timeFrame: During follow-up visit (20-48 hours post tube placement)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St.Vincent Hospital and Health Care Center, Inc.
state: Indiana
Study officials:
affiliation: St.Vincent Hospital and Health Care Center, Inc.
name: Lewis Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References: