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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment CORTRAK Stylet for feeding tube placement verification in enteral nutrition?

Research shows that the CORTRAK Enteral Access System (CEAS) is effective in placing feeding tubes, with an 83% success rate in positioning nasojejunal tubes in ICU patients. It is a simple bedside tool that can reduce the need for X-ray confirmation, saving time and costs. ^{1 2 3 4 5}

Is the CORTRAK system safe for feeding tube placement?

The CORTRAK system is generally considered safe for feeding tube placement, but it requires trained users to avoid complications like pneumothorax (air in the space around the lungs). Some studies suggest that user expertise is crucial for safe use. ^{1 2 5 6 7}

How is the CORTRAK Stylet treatment different from other feeding tube placement methods?

The CORTRAK Stylet is unique because it uses electromagnetic guidance to place feeding tubes, allowing for real-time visualization and potentially eliminating the need for X-ray confirmation. This method can be performed at the bedside by trained nurses, making it more convenient and cost-effective compared to traditional endoscopic or radiological placement methods. ^{1 2 3 5 7}

Research Team

Andrew Meyer, MD

Principal Investigator

University of Texas Health at San Antonio

Eligibility Criteria

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.

I am 17 years old or younger.

Exclusion Criteria

The CORTRAK Stylet has been inserted incorrectly.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Small-bore feeding tubes placed with an electromagnetic imaging device leads to cost avoidance and decreased time to initiation of enteral nutrition. [2023]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Nasopharyngeal perforation by a new electromagnetically visualised enteral feeding tube. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

An evaluation of the Cortrak Enteral access system in our intensive care. [2019]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cortrak-Assisted Feeding Tube Insertion: A Comprehensive Review of Adverse Events in the MAUDE Database. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

CORTRAK Superuser Competency Assessment and Training Recommendations. [2020]