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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube (FT) position on a daily basis to assess for migration. The EMPD provides real-time FT placement data. A sensor located on the distal end of the FT guidewire communicates with a receiver unit which sits on the patient's abdomen. Three visual insertion tracings with varying views (anterior, lateral, and depth/cross-section) can be saved and printed for comparison.

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 data supports the idea that Electromagnetic Placement Device for Enteral Nutrition is an effective treatment?

The available research does not provide any data on the effectiveness of the Electromagnetic Placement Device for Enteral Nutrition. The studies mentioned focus on different medical devices and treatments for conditions like intracranial aneurysms and stroke prevention, but none of them address the Electromagnetic Placement Device or its effectiveness for enteral nutrition. ^{1 2 3 4 5}

What safety data is available for the Electromagnetic Placement Device for Enteral Nutrition?

The provided research does not contain specific safety data for the Electromagnetic Placement Device for Enteral Nutrition or its other names like Cortrak 2 Enteral Access System, Cortrak 2 EAS, or EMPD. The studies focus on electronic medication management systems and electronic medical records, which are unrelated to the device in question. ^{6 7 8 9 10}

Is the Electromagnetic Placement Device a promising treatment for enteral nutrition?

Yes, the Electromagnetic Placement Device is a promising treatment for enteral nutrition. It allows for real-time guidance of feeding tube placement, which can reduce complications like misplacement and the need for X-rays. This can lead to quicker feeding starts, improved patient experiences, and potential cost savings. ^{11 12 13 14 15}

Research Team

Jan R Powers

Principal Investigator

Parkview Health

Eligibility Criteria

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

Cortrak guidewire available

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

All 3 views from my initial Cortrak insertion are available.

Exclusion Criteria

Pregnancy

Prisoners

Unable to speak or understand English language

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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 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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy. [2021]

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

Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis. [2022]

3. United States 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. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

The Combined Use of Intraluminal and Intrasaccular Flow Diversion for the Treatment of Intracranial Aneurysms: Report of 25 Cases. [2023]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Medication safety incidents in paediatric oncology after electronic medication management system implementation. [2020]

7. Ireland 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. [2023]

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

Rapid Electronic Provider Documentation Design and Implementation in an Academic Pediatric Emergency Department. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Design challenges for electronic medication administration record systems in residential aged care facilities: a formative evaluation. [2018]

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

Peripheral activities during EMR use in emergency care: a case study. [2021]

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

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

12. England 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. [2020]

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

CORTRAK Superuser Competency Assessment and Training Recommendations. [2020]

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

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial. [2018]

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

Electromagnetic Sensor-Guided Enteral Access Systems: A Literature Review. [2022]