Placement of the Entarik Feeding Tube System in ICU patients

Entarik Feeding Tube System Placement in Adult ICU

This study tests if a new feeding tube system is safe and effective for giving nutrition and medications to adult patients in the ICU who need help eating for more than six hours.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gravitas Medical, Inc. (Industry-sponsored)
• Locations: 2 sites (Bradenton, Florida and 1 other locations)
• Trial ID: NCT05884216 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Entarik Feeding Tube System for administering nutrition, fluids, and medications to adult patients in the ICU. It involves the placement of a nasogastric tube in patients who require enteral feeding for more than six hours. The study will assess both the standard placement of the feeding tube and a version without monitoring to determine the best approach for patient care.

Who should consider this trial

Good fit: Ideal candidates are adults in the ICU who require a nasogastric tube for enteral feeding and can provide informed consent.

Not a fit: Patients with a history of esophagitis or strictures that prevent the placement of a feeding tube will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and efficiency of enteral feeding in critically ill patients.

How similar studies have performed: While similar approaches have been explored, the specific use of the Entarik Feeding Tube System in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Must be able to swallow tabletsAt least 18 years old
* Able to provide informed consent or ability to have a legally authorized representative provide informed consent
* Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
* Suitable to start enteral (gastric but no post-pyloric) feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion Criteria:

* inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
* Known major upper airway malformation
* Known major GI abnormality, upper GI malignancy, or partial gastric resection
* History of gastroparesis
* Currently pregnant
* NPO status - expected to remain NPO for the following 72 hours.
* Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
* Critically ill, facing imminent death
* Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

Where this trial is running

Bradenton, Florida and 1 other locations

• Nova Clinical Research at HCA Florida Blake Hospital — Bradenton, Florida, United States (Not_yet_recruiting)
• HCA Chippenham and Johnston-Willis Medical Center — Richmond, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Carleen Tabari

Conditions Nasogastric Tube