30 Participants Needed

Entarik Feeding Tube System for Airway Data Collection in Healthy Subjects

AM
Overseen ByAaron Miller
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on active anticoagulation therapy (blood thinners), you may be deemed unsuitable for the study.

What data supports the effectiveness of the Entarik Feeding Tube System treatment?

The research on ICU nutrition support practices shows that using structured feeding protocols can improve the adequacy of nutrition support, suggesting that systems like the Entarik Feeding Tube System may help ensure patients receive the right amount of nutrition safely.12345

Is the Entarik Feeding Tube System safe for use in humans?

The Entarik Feeding Tube System is described as inherently safe in one study, which mentions that it only removes excess fluids momentarily to prevent local distention (swelling). Another study highlights the importance of proper placement and management to avoid complications, suggesting that safety can be enhanced with team-based protocols and technology.16789

How does the Entarik Feeding Tube System treatment differ from other treatments for airway data collection?

The Entarik Feeding Tube System is unique because it is designed specifically for noninvasive airway data collection during feeding, focusing on the coordination between swallowing and respiration. Unlike other methods, it aims to provide accurate respiratory information during feeding assessments, which is crucial for understanding swallowing safety and efficiency.1011121314

What is the purpose of this trial?

The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.

Research Team

DB

Daniel Burnett, MD

Principal Investigator

Theranova, LLC

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to evaluate the performance of a new feeding tube system called Entarik. Specific eligibility criteria are not provided, so general good health seems to be the main requirement.

Inclusion Criteria

Able to provide informed consent
I am an adult scheduled for a bronchoscopy and will be intubated.

Exclusion Criteria

Currently pregnant
I have a known bleeding disorder.
I have a serious lung infection.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Entarik Feeding Tube is placed into the airway through an endotracheal tube under direct visualization while data is collected

During the procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

Treatment Details

Interventions

  • Entarik Feeding Tube System
Trial Overview The study is testing how well the Entarik Feeding Tube System detects the airway when inserted and collects data while it's in place. This research will help improve the device.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Healthy AdultsExperimental Treatment1 Intervention
Airway insertion

Find a Clinic Near You

Who Is Running the Clinical Trial?

Theranova, L.L.C.

Lead Sponsor

Trials
14
Recruited
540+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

References

Colorimetric carbon dioxide detector to determine accidental tracheal feeding tube placement. [2013]
Review of ICU nutrition support practices: implementing the nurse-led enteral feeding algorithm. [2016]
The development and validation of a quality-of-life questionnaire for head and neck cancer patients with enteral feeding tubes: the QOL-EF. [2022]
Variables associated with feeding tube placement in head and neck cancer. [2015]
Does feeding tube placement predict for long-term swallowing disability after radiotherapy for head and neck cancer? [2019]
Enteral feeding monitor/manager. [2022]
A team-based protocol and electromagnetic technology eliminate feeding tube placement complications. [2011]
Before-after study of a standardized ICU protocol for early enteral feeding in patients turned in the prone position. [2019]
Risks in Management of Enteral Nutrition in Intensive Care Units: A Literature Review and Narrative Synthesis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Comparative review of techniques for recording respiratory events at rest and during deglutition. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
The synchronization of respiration and swallow sounds with videofluoroscopy during swallowing. [2019]
Limitations of the computerized laryngeal analyzer (CLA) in the assessment of the swallowing mechanism. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Development of a Non-invasive Device for Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia: Results from a Prospective Exploratory Study. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
Visual Analysis of Swallowing Efficiency and Safety (VASES): A Standardized Approach to Rating Pharyngeal Residue, Penetration, and Aspiration During FEES. [2022]
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