Electromagnetic Placement Device for Enteral Nutrition

Overseen By Jan Powers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Parkview Health

Disqualifiers: Pregnancy, Prisoners, Language barrier, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Electromagnetic Placement Device (also known as Cortrak* 2 Enteral Access System or Cortrak 2 EAS), which checks the position of a feeding tube in real-time to ensure it remains correctly placed. The device uses electromagnetic technology to pinpoint the tube's location in the body, helping to prevent complications. Suitable candidates include critical care patients who have had a feeding tube placed within the last 24-48 hours and can maintain it for a bit longer. As an unphased trial, this study allows patients to contribute to innovative research that could enhance the safety of feeding tube placement.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this electromagnetic placement device is safe for verifying feeding tube position?

Research has shown that the Cortrak 2 Enteral Access System, a device for placing feeding tubes, is designed to enhance safety. Studies have found that this device reduces errors when placing feeding tubes in the stomach or intestines, which is crucial because mistakes can lead to complications.

The device uses electromagnetic sensing to track the tube's path inside the body and provides real-time feedback on its position. This feature helps doctors ensure correct tube placement. Medical settings have tested and used the system, and patients generally tolerate it well. Significant problems directly caused by the device have not been reported.

Overall, the device is considered safe and effective for its purpose. It has successfully reduced risks associated with feeding tube placements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electromagnetic Placement Device (EMPD) for enteral nutrition because it offers a cutting-edge method to assess feeding tube migration. Unlike traditional methods that rely on X-rays or less precise techniques, the EMPD uses electromagnetic technology to accurately detect tube placement in real-time. This method not only enhances patient safety by reducing exposure to radiation but also ensures quicker and more precise adjustments, potentially improving outcomes in critical care settings.

What evidence suggests that this electromagnetic placement device is effective for assessing feeding tube migration?

Studies have shown that the Cortrak 2 Enteral Access System, an electromagnetic device, helps ensure correct placement of feeding tubes. This system uses a sensor and a receiver to track the tube's position inside the body. Research indicates that this device reduces errors in tube placement, preventing complications. One study found it more effective than placing tubes without guidance. The device also improves safety for patients needing feeding tubes. Participants in this trial will use the Cortrak 2 Enteral Access System to assess feeding tube migration in eligible critical care patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Jan R Powers

Principal Investigator

Parkview Health

Are You a Good Fit for This Trial?

This trial is for adult critical care patients who recently had a small bore feeding tube inserted and can understand English. They must have initial Cortrak insertion tracings and the guidewire available. It's not for pregnant individuals, prisoners, those with feeding tubes expected to be removed within a day, or if they can't have a mark placed on their abdomen.

Inclusion Criteria

I am in critical care and had a small feeding tube inserted in the last 1-2 days.

Cortrak guidewire available

All 3 views from my initial Cortrak insertion are available.

Exclusion Criteria

Pregnancy

Prisoners

Unable to speak or understand English language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Daily verification of feeding tube position using an electromagnetic placement device to assess for migration

5 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Electromagnetic Placement Device

Trial Overview The study tests an electromagnetic placement device (EMPD), specifically the Cortrak* 2 Enteral Access System, which checks the position of feeding tubes daily to see if they've moved by providing real-time data through a sensor-guidewire system.

How Is the Trial Designed?

Group I: feeding tube migration Experimental Treatment 1 Intervention

Use of an EMPD to assess for FT migration in all eligible critical care patients requiring the use of a feeding tube during admission.

Electromagnetic Placement Device is already approved in United States for the following indications:

Approved in United States as Cortrak* 2 Enteral Access System for:

• Enteral feeding tube placement

Who Is Running the Clinical Trial?

Parkview Health

Lead Sponsor

Trials

10

Recruited

960+

Published Research Related to This Trial

A novel electronic provider documentation (EPD) system with voice recognition was successfully designed and implemented in a pediatric emergency department within 7 months, showing that rapid transitions to electronic systems are feasible.

After the EPD implementation, there was a slight increase in patient length of stay (LOS), particularly a temporary 9.3% increase in discharge LOS, but overall, the system did not significantly negatively impact emergency department metrics, and compliance with chart completion improved over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Electronic Provider Documentation Design and Implementation in an Academic Pediatric Emergency Department. Lo, MD., Rutman, LE., Migita, RT., et al.[2015]

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

A systematic review of 21 studies revealed that while various human factors and safety analysis methods were used in the design of electronic medication management systems (EMMS), most focused on usability rather than safety, highlighting a gap in safety-oriented approaches.

The most common methods employed included prototyping and usability testing, which were primarily aimed at identifying usability issues, indicating a need for more comprehensive safety assessments in the design of EMMS to mitigate patient safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human factors and safety analysis methods used in the design and redesign of electronic medication management systems: A systematic review. Awad, S., Amon, K., Baillie, A., et al.[2023]

In a study analyzing 827 safety incident reports from a pediatric oncology unit over 18 months, approximately 79% of incidents were related to medication, with nearly 45% linked to the electronic medication management system (EMM).

The EMM contributed to safety issues through technical problems, user experience challenges, unexpected workflow issues, and missing safety features, highlighting the need for users to be aware of the system's automatic behaviors and to be prepared to troubleshoot them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication safety incidents in paediatric oncology after electronic medication management system implementation. Lichtner, V., Baysari, M., Gates, P., et al.[2020]

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]

Electromagnetic-guided placement (EMP) of nasoduodenal feeding tubes is as effective and safe as EGD-guided placement (EGDP), with comparable success rates of post-pyloric tube positioning (82% for EMP vs 79% for EGDP) in a study of 155 patients.

EMP is associated with lower costs ($519.09) compared to EGDP ($622.49), suggesting that EMP could be a more economical option for healthcare facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial. Kappelle, WFW., Walter, D., Stadhouders, PH., et al.[2018]

Electromagnetic sensor-guided enteral access systems (EMS-EAS) significantly reduce the risk of misplacement of nasoenteric feeding tubes, virtually eliminating complications such as pneumothorax, which are common with conventional methods.

Using EMS-EAS allows for quicker confirmation of tube placement, leading to a faster start of enteral feeding, which can improve patient outcomes, reduce hospital stay, and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic Sensor-Guided Enteral Access Systems: A Literature Review. Smithard, D., Barrett, NA., Hargroves, D., et al.[2022]

The evaluation of an electronic medication administration record (eMAR) system in an Australian residential aged care facility revealed that it does not fully integrate medication management, as many processes still rely on manual methods like paper charts and faxing.

Five key design challenges were identified, including limited interactivity and inadequate decision support, suggesting that improvements in these areas could enhance medication safety and workflow efficiency before the system's wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design challenges for electronic medication administration record systems in residential aged care facilities: a formative evaluation. Tariq, A., Lehnbom, E., Oliver, K., et al.[2018]

The study involving 165 patients undergoing transcatheter aortic valve replacement (TAVR) showed that the Sentinel Cerebral Protection System can be safely and effectively inserted, even in patients with the challenging bovine aortic arch anatomy, with an overall successful insertion rate of 86.6%.

No procedural complications or strokes occurred during the procedure, indicating that the use of CEPDs like Sentinel is safe, and it effectively captured debris in 95% of cases, suggesting a strong potential to reduce stroke risk during TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy. Tagliari, AP., Ferrari, E., Haager, PK., et al.[2021]

A meta-analysis of 10 studies involving 159,865 patients found that cerebral embolic protection devices (CEPDs) did not significantly reduce the risk of 30-day strokes during transcatheter aortic valve implantation (TAVI).

The analysis also showed no significant differences in silent ischemic lesions or neurocognitive function between patients who received CEPDs and those who did not, indicating that CEPDs may not provide the expected protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis. Pérez-Camargo, D., Travieso, A., Carnero-Alcázar, M., et al.[2022]

The Medina Embolic Device (MED) combined with flow diverter stents (FDS) showed promising results in treating aneurysms, with 89% complete exclusion in a staged treatment group and 60% in a simultaneous treatment group over an average follow-up of 8 to 10 months.

While there were some complications, including permanent morbidity in two patients, there were no fatalities, suggesting that the MED + FDS strategy is a relatively safe alternative for selected aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Combined Use of Intraluminal and Intrasaccular Flow Diversion for the Treatment of Intracranial Aneurysms: Report of 25 Cases. Bhogal, P., AlMatter, M., Hellstern, V., et al.[2023]

In a study of 492 aneurysms treated with the Pipeline Embolization Device (PED) from 2013 to 2019, off-label use showed similar rates of complete and near-complete occlusion compared to on-label use (80.9% vs 85.7%), indicating its potential effectiveness for challenging cases.

However, off-label treatment was associated with a significantly higher rate of poor functional outcomes (10.3% vs 3.5%) and a trend towards increased intracranial hemorrhagic complications (4.7% vs 1.6%), suggesting that while off-label use can be beneficial, it carries additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study. Enriquez-Marulanda, A., Penumaka, A., Ogilvy, CS., et al.[2022]

The use of electronic medical record (EMR) systems in emergency departments can lead to peripheral activities, such as transitioning between multiple artifacts and locations, which may disrupt patient care continuity.

These peripheral activities can introduce errors and bottlenecks in patient flow, highlighting the need for better integration of EMR applications with emergency department practices to improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral activities during EMR use in emergency care: a case study. Abraham, J., Kannampallil, TG., Reddy, MC.[2021]

The FRED X flow diversion device was successfully used in 44 patients with 45 intracranial aneurysms, demonstrating technical feasibility with 100% successful stent placements and promising early safety outcomes, as only 4 patients experienced symptomatic complications.

At 6 months post-treatment, 89% of the aneurysms showed adequate occlusion, indicating effective treatment, while all patients maintained excellent functional outcomes with a modified Rankin Scale score of 0.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First United States multicenter experience with the new-generation FRED X surface-modified flow diversion stent: feasibility, safety, and short-term efficacy. Abbas, R., Lan, M., Naamani, KE., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06239610

DrIFT 2 Study: Displacement in Feeding Tubes The proposed study will use an electromagnetic placement device (EMPD), Cortrak* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube (FT) ...

2. avanos.com avanos.com/enteral-feeding/cortrak-2-enteral-access-system-eas/

CORTRAK* 2 Enteral Access System (EAS) Improved Safety and Efficacy of Small-Bore Feeding Tube Confirmation Using an Electromagnetic Placement Device. Nutr Clin Pract. 2018 Apr;33(2):268-273. 5 ...

3. 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 ... The aim of the study was to evaluate the effectiveness of post- pyloric feeding tube placement using CORTRAK 1 EAS compared with blind placement ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4469250/

Electromagnetic Sensor-Guided Enteral Access Systems This review suggests that EMS-EAS reduces several complications associated with the misplacement of nasoenteric feeding tubes.

5. withpower.com withpower.com/trial/phase-nutrition-enteral-2-2024-a2b1c

Electromagnetic Placement Device for Enteral Nutrition The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K191340.pdf

June 4, 2019 Avanos Medical, Inc. Dave Yungvirt CEO Third ... CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos feeding tube tip during the ...