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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.
Two previous studies have been completed with similar methodology. A pilot study of 50 subjects was performed using the original Cortrak* (2 insertion views) and found only minimal forward migration. No reverse migration was reported in one study.
A pilot study of 20 patients with 62 feeding tube assessment identified 8 migration events (5 retrograde and 3 forward), these events only occurred within the small bowel. Based on this data, a recommendation could be made that there is no need to check feeding tube placement routinely every four hours. However, due to the small sample size, additional research is needed to confirm this finding. It is also unknown if there may be more migration with positioning changes, for example, up in the chair or prone position.
The proposed study will use an electromagnetic placement device (EMPD), Cortrak* 2 Enteral Access System (EAS™), Avanos Medical, to verify FT position on a daily basis to assess for migration. The proposed study will take place in critical care units at Parkview Health. The primary aim will be to determine if replication of the pilot study results in similar findings. Investigators will also explore other factors that may be associated with FT migration, such as patient mobility (ambulation or sitting at bedside or prone position) and transporting out of the critical care unit for diagnostic procedures. Researchers anticipate that results from this study will provide a better understanding of FT position and migration over time and ultimately influence recommendations for practice for frequency of routine FT verification. Standard of care for assessing feeding tube placement location every 4 hours will remain in place. The study will add an additional assessment for feeding tube location daily. This study will expand on the findings from the initial pilot study with a larger sample size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| feeding tube migration | Other | Use of an EMPD to assess for FT migration in all eligible critical care patients requiring the use of a feeding tube during admission. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electromagnetic placement device | Device | Daily use of an EMPD to verify FT position |
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| Measure | Description | Time Frame |
|---|---|---|
| Tube Migration | Number of participants with clincially significant feeding tube retrograde migration | 5 days or until FT removed, whichever came first |
| Effect of ETT Extubation on FT Movement | Number of participants with clincially significant retrograde migration after extubation | 5 days or until FT removed, whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan R Powers | Parkview Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46835 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21527596 | Background | Metheny NA, Stewart BJ, McClave SA. Relationship between feeding tube site and respiratory outcomes. JPEN J Parenter Enteral Nutr. 2011 May;35(3):346-55. doi: 10.1177/0148607110377096. | |
| 27037348 | Background | Initial and Ongoing Verification of Feeding Tube Placement in Adults (applies to blind insertions and placements with an electromagnetic device). Crit Care Nurse. 2016 Apr;36(2):e8-e13. doi: 10.4037/ccn2016141. No abstract available. |
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A data sharing agreement is in place stipulating that data provided to Data Recipient will not contain any "Protected Health Information" (as that term is defined in the HIPAA privacy rule at 45 C.F.R. §160.103) and shall be de-identified in accordance with 45 C.F.R. §164.514(b) of the HIPAA privacy rule. he Parties agree that the Data will be completely De-Identified.
Data will become available after data cleaning and analysis, which is anticpated to be 10 months.
All data will be de-identified and in aggregate format.
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One patient was removed due to a missing feeding tube stylet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Feeding Tube Migration | 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: Daily use of an EMPD to verify FT position |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Feeding Tube Migration | 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: Daily use of an EMPD to verify FT position |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tube Migration | Number of participants with clincially significant feeding tube retrograde migration | Posted | Count of Participants | Participants | 5 days or until FT removed, whichever came first |
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4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feeding Tube Migration | 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: Daily use of an EMPD to verify FT position |
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This study occurred at a single study site with a small sample size. Multisite and larger sample size studies would increase the confidence around the size of our estimated effects and may also identify different factors associated with migration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Powers PhD, RN, CCNS, CCRN, CNRN, NE-BC, FCCM | Parkview Health System | 260-266-7761 | jan.powers@parkview.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2024 | Jun 17, 2025 | Prot_SAP_000.pdf |
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longitudinal, repeated measures design replication study
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| 25639583 | Background | Bourgault AM, Heath J, Hooper V, Sole ML, Nesmith EG. Methods used by critical care nurses to verify feeding tube placement in clinical practice. Crit Care Nurse. 2015 Feb;35(1):e1-7. doi: 10.4037/ccn2015984. |
| 22941709 | Background | Metheny NA, Stewart BJ, Mills AC. Blind insertion of feeding tubes in intensive care units: a national survey. Am J Crit Care. 2012 Sep;21(5):352-60. doi: 10.4037/ajcc2012549. |
| 25900711 | Background | Milsom SA, Sweeting JA, Sheahan H, Haemmerle E, Windsor JA. Naso-enteric Tube Placement: A Review of Methods to Confirm Tip Location, Global Applicability and Requirements. World J Surg. 2015 Sep;39(9):2243-52. doi: 10.1007/s00268-015-3077-6. |
| 11434652 | Background | Kearns PJ, Donna C. A controlled comparison of traditional feeding tube verification methods to a bedside, electromagnetic technique. JPEN J Parenter Enteral Nutr. 2001 Jul-Aug;25(4):210-5. doi: 10.1177/0148607101025004210. |
| 2119031 | Background | Metheny N, McSweeney M, Wehrle MA, Wiersema L. Effectiveness of the auscultatory method in predicting feeding tube location. Nurs Res. 1990 Sep-Oct;39(5):262-7. |
| 23547123 | Background | Makic MB, Martin SA, Burns S, Philbrick D, Rauen C. Putting evidence into nursing practice: four traditional practices not supported by the evidence. Crit Care Nurse. 2013 Apr;33(2):28-42. doi: 10.4037/ccn2013787. |
| 33130862 | Background | Bourgault AM, Powers J, Aguirre L, Hines R. Migration of Feeding Tubes Assessed by Using an Electromagnetic Device: A Cohort Study. Am J Crit Care. 2020 Nov 1;29(6):439-447. doi: 10.4037/ajcc2020744. |
| 28249868 | Background | Bourgault AM, Aguirre L, Ibrahim J. Cortrak-Assisted Feeding Tube Insertion: A Comprehensive Review of Adverse Events in the MAUDE Database. Am J Crit Care. 2017 Mar;26(2):149-156. doi: 10.4037/ajcc2017369. |
| 35985807 | Background | Bourgault AM, Deb C, Aguirre L, Xie R, Rathbun KP, Sole ML. Microbiome profile informs cleansing and storage practices for reusable feeding tube stylets in critical care. Nutr Clin Pract. 2023 Apr;38(2):411-424. doi: 10.1002/ncp.10904. Epub 2022 Aug 19. |
| 24244058 | Background | Wang MC, Chang SH. Nonparametric Estimation of a Recurrent Survival Function. J Am Stat Assoc. 1999 Mar 1;94(445):146-153. doi: 10.1080/01621459.1999.10473831. |
| Participants |
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| Age, Continuous | The 12 patients, who could not be included due to only having one day of FT zone data, were reviewed for reasons of withdrawal. Five (42%) of these patients had unexpected withdrawal of care due to family decisions or hospice admission. Four patients had their FTs removed during ETT extubation. Two patients improved significantly and were able to start an oral diet. One patient was removed due to a missing feeding tube stylet. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Primary | Effect of ETT Extubation on FT Movement | Number of participants with clincially significant retrograde migration after extubation | Total number of participants in study (n=108) who were intubated 30/108. | Posted | Count of Participants | Participants | 5 days or until FT removed, whichever came first |
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