What side effects are associated with this type of intervention?

Common treatments for enteral nutrition, particularly those involving feeding tube placement like the CORTRAK enteral access system, can have several side effects. These may include mechanical complications such as tube dislodgement, blockage, or misplacement, which can lead to aspiration pneumonia if the tube enters the respiratory tract. Gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal distension are also common. Additionally, there can be metabolic disturbances, including electrolyte imbalances and hyperglycemia. Proper technique and monitoring are essential to minimize these risks.

What prior FDA approvals exist?

The FDA has approved various devices and systems for enteral nutrition, including feeding tubes and enteral access systems. While specific FDA approvals for electromagnetic tracking systems like the CORTRAK enteral access system are not detailed, the CORTRAK system itself is an advanced method for real-time feeding tube placement, enhancing accuracy and reducing the need for confirmatory X-rays. Broadly, FDA-approved treatments for enteral nutrition focus on ensuring safe and effective delivery of nutrition to patients who cannot consume food orally, with devices designed to minimize complications and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to the CORTRAK enteral access system for enteral nutrition patients include: 1) Endoscopically-delivered miniaturized stimulators that enhance slow wave regularity and amplitudes, 2) Percutaneous electrode systems for neurostimulating pulses, and 3) Multichannel gastric electrical stimulation devices that deliver high-energy pulses to enhance gastric emptying. These technologies are being developed to improve the precision and efficacy of enteral nutrition delivery.

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Device

CORTRAK for Feeding Tube Placement Verification in Enteral Nutrition

N/A

Waitlist Available

Led By Andrew Meyer, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CORTRAK feeding tube placed as part of clinical care

Pediatric patients (Aged 17 or younger)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to removal of feeding tube (on average 10-14 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the accuracy of the CORTRAK system to x-rays in locating feeding tubes in pediatric patients who are already receiving x-rays as part of their routine care.

Who is the study for?

This trial is for pediatric patients (17 or younger) who are receiving enteral nutrition and need their feeding tube position confirmed. They must be getting an x-ray for any reason and have a CORTRAK Stylet available in the room. The study excludes those where the CORTRAK Stylet has been misplaced.

What is being tested?

The study is testing how well the CORTRAK enteral access system can confirm the correct placement of feeding tubes in the abdomen compared to traditional x-ray methods.

What are the potential side effects?

Since this trial involves comparing two methods of confirming tube placement rather than medication, there may not be direct side effects like with drugs; however, potential risks could include discomfort or complications from incorrect tube positioning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a CORTRAK feeding tube installed.

Select...

I am 17 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to removal of feeding tube (on average 10-14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to removal of feeding tube (on average 10-14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to removal of feeding tube (on average 10-14 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tube feeding of patient

Secondary study objectives

Number of Radiographs required for placement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Feeding Tube Placement using CORTRAK styletActive Control1 Intervention

Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation.

Group II: Feeding Tube Placement using X-RayActive Control1 Intervention

Routine X-ray is used to confirm feeding tube placement

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Enteral nutrition involves delivering nutrients directly to the gastrointestinal tract, typically via a feeding tube. The most common treatments include the use of specialized formulas tailored to meet the nutritional needs of patients, and the precise placement of feeding tubes to ensure proper nutrient delivery and minimize complications. The CORTRAK enteral access system enhances this process by using electromagnetic tracking to provide real-time visualization of the feeding tube's position, reducing the risk of misplacement and associated complications such as aspiration or tube dislodgement. This technology is crucial for enteral nutrition patients as it ensures accurate and safe delivery of nutrition, which is essential for their recovery and overall health.