CORTRAK for Feeding Tube Placement Verification in Enteral Nutrition

Overseen By Megan Foster, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Cortrak stylet misplaced

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10-14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for verifying the correct placement of feeding tubes in the body. It compares the CORTRAK system, a specialized tool for guiding the tube, with the standard X-ray method. The goal is to determine if CORTRAK can match the accuracy of X-rays in confirming tube placement. Children who already have a feeding tube and require an X-ray for any reason might be suitable for this trial. Participants will have their tube placement checked using either CORTRAK or the standard X-ray method. As an unphased trial, this study allows participants to contribute to advancing medical technology without the constraints of traditional clinical trial phases.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CORTRAK enteral access system is safe for feeding tube placement?

Research has shown that the CORTRAK Stylet is a safe tool for checking feeding tube placement. This device uses electromagnetic technology to track the tube's path during insertion. Studies have found it both practical and safe for guiding feeding tubes into the stomach or small intestine.

The CORTRAK Stylet has been used many times without major problems, reducing the risk of incorrect tube placement compared to older methods like blind placement. The device accurately confirms the tube's location, helping to prevent complications.

Overall, the CORTRAK Stylet is well-tolerated, and studies have not reported any severe side effects. This makes it a reliable choice for those needing feeding tube placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the CORTRAK stylet for feeding tube placement verification because it offers a real-time tracking method that could potentially eliminate the need for confirmatory X-rays. Unlike the standard method that relies on X-rays, which can expose patients to radiation and require additional time for results, CORTRAK provides immediate feedback on tube placement. This not only speeds up the process but also enhances patient safety by reducing radiation exposure.

What evidence suggests that the CORTRAK system is effective for feeding tube placement verification?

Research has shown that the CORTRAK Enteral Access System (CEAS) effectively places feeding tubes, achieving an 83% success rate for nasojejunal tubes. One study found the CORTRAK system to be 100% accurate in verifying tube position, ensuring correct placement without harm. This trial will compare feeding tube placement using the CORTRAK stylet with the traditional X-ray method for placement confirmation. The CORTRAK system reduces the need for X-rays, decreasing radiation exposure for patients. It is safe and cost-effective, preventing incorrect tube placement, such as in the airway. Overall, the CORTRAK system reliably ensures feeding tubes are correctly placed in the stomach or small intestine. ^{4 5 6 7 8}

Who Is on the Research Team?

Andrew Meyer, MD

Principal Investigator

University of Texas Health at San Antonio

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You recently had an X-ray for any reason.

I have a CORTRAK feeding tube installed.

CORTRAK Stylet available in the room

Exclusion Criteria

The CORTRAK Stylet has been inserted incorrectly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Comparison of feeding tube placement accuracy using CORTRAK system versus X-ray

10-14 days

Inpatient monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CORTRAK Stylet

Trial Overview 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.

How Is the Trial Designed?

Group I: Feeding Tube Placement using CORTRAK stylet Active Control 1 Intervention

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

Group II: Feeding Tube Placement using X-Ray Active Control 1 Intervention

Routine X-ray is used to confirm feeding tube placement

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

The CORTRAK enteral access system (CEAS) was successfully used to place nasojejunal feeding tubes in all 56 critically ill patients, including those with low platelet counts and anticoagulation therapy, indicating its efficacy and safety in challenging clinical situations.

While epistaxis (nosebleeds) occurred in 48.2% of patients, most cases were mild, and no severe bleeding complications were reported, suggesting that CEAS can be safely used even in patients with thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of electromagnetic sensing aided post pyloric feeding tube placement (CORTRAK) in patients with thrombocytopenia with or without anticoagulation on the intensive care unit. Stecher, SS., Barnikel, M., Drolle, H., et al.[2022]

A pilot study involving 20 nurses showed that while most participants felt confident in using the CORTRAK system for feeding tube insertion, they estimated needing at least 8 insertions to feel fully competent, highlighting the importance of practice in mastering this skill.

Despite the use of the CORTRAK system, some nurses still relied on traditional methods like auscultation to confirm tube placement, indicating that confidence in interpreting the system's readings may take longer to develop and suggesting a need for more training opportunities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CORTRAK Superuser Competency Assessment and Training Recommendations. Bourgault, AM., Gonzalez, L., Aguirre, L., et al.[2020]

A review of 54 adverse events related to the CORTRAK Enteral Access System revealed that a significant number of feeding tubes (98%) were incorrectly placed in the lungs, leading to serious complications such as pneumothorax and pneumonitis, with a 17% mortality rate in these cases.

The study highlights the need for specialized training for clinicians using the CORTRAK device, as 89% of insertion tracings were misinterpreted, indicating that user expertise is crucial for safe feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortrak-Assisted Feeding Tube Insertion: A Comprehensive Review of Adverse Events in the MAUDE Database. Bourgault, AM., Aguirre, L., Ibrahim, J.[2018]

The Cortrak Enteral Access System (CEAS) successfully placed nasojejunal tubes in 83% of patients in an ICU setting, demonstrating its effectiveness for ensuring enteral nutrition despite challenges like decreased gastric emptying.

Using the CEAS for tube placement took about 30 minutes and allowed for enteral feeding to continue for 2 to 15 days, highlighting its potential as a cost-effective and efficient method for delivering nutrition in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the Cortrak Enteral access system in our intensive care. Dolan, AM., O'Hanlon, C., O'Rourke, J.[2019]

The Cortrak® feeding tube, which is placed at the bedside using electromagnetic guidance, could potentially replace traditional endoscopic methods for at least 25% of duodenal tube placements in a hospital setting, based on a review of 487 placements in 331 patients.

As the use of Cortrak® becomes more routine, it is estimated that over 50% of patients needing naso-duodenal feeding tubes, including those in ICU, could qualify for this method, suggesting a significant opportunity for improved patient care and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortrak&#174; duodenal tube placements: A solution for more patients? A&#160;preliminary survey to the introduction of electromagnetic-guided placement of naso-duodenal feeding tubes. Arjaans, W., Ouwehand, M., Bouma, G., et al.[2020]

Citations

1. nice.org.uk nice.org.uk/advice/mib48/resources/cortrak-2-enteral-access-system-for-placing-nasoenteral-feeding-tubes-pdf-63499172779717

CORTRAK 2 Enteral Access System for placing ... Secondary outcomes: • Success rate of post-pyloric feeding tube placement. • Percent where inadvertent airway placement was avoided. • ...

2. withpower.com withpower.com/trial/phase-2021-10f96

CORTRAK for Feeding Tube Placement Verification in ... Research shows that the CORTRAK Enteral Access System (CEAS) is effective in placing feeding tubes, with an 83% success rate in positioning nasojejunal tubes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4095205/

Using the Cortrak magnetic device to facilitate early enteral ... The Cortrak demonstrated 100% accuracy in confirming the position of NGT in this patient series. It exposes patients to less radiation, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417910001944

The use of the Cortrak Enteral Access System™ for post- ... The Cortrak system is safe and effective on BITU. It reduces calorie deficit, reduces X-ray exposure and is cost effective. We recommend its use on BITU.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6861064/

Feasibility and safety of a novel electromagnetic device for ... A novel electromagnetic system demonstrated feasibility and safety of real-time and follow-up tracking of EFT placement into the stomach and small intestine.

6. avanos.com avanos.com/product-catalog/product/cortrak-2-nasogastric-nasointestinal-feeding-tubes/

CORTRAK* 2 Nasogastric / Nasointestinal Feeding Tubes This CORTRAK* 2 Nasogastric/Nasointestinal tube and transmitting stylet have been designed for use with the CORTRAK* 2 Enteral Access System.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725003195

Technology advances in the placement of naso-enteral ... A local data analysis showed that Respiratory tube misplacement was detected in the order: X-ray for blind placement < Cortrak traces < IRIS direct vision (1.7 ...

8. integration.cdn.cosanum.camptocamp.ch integration.cdn.cosanum.camptocamp.ch/shop/tds-corflo-trak2-eng-july-21-279636.pdf

TECHNICAL DATA SHEET - Camptocamp SA CORTRAK* 2 EAS can be used to confirm placement of CORTRAK* 2 feeding tubes prior to commencing the delivery of enteral nutrition. SINGLE PATIENT USE.