DrIFT 2 Study: Displacement in Feeding Tubes

NCT06239610 | Completed Results FDA Device

• 1 other identifier: NUR23-1127DrIFT2
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enteral Nutrition

Keywords

feeding tube; coretrak; tube migration; critical care; enteral nutrition; gastric tube feeding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: electromagnetic placement device

Interventions

electromagnetic placement device DEVICE

Daily use of an EMPD to verify FT position

Also known as: Cortrak* 2 Enteral Access System

feeding tube migration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult critical care patients with small bore feeding tube inserted within last 24-48 hours
• Initial Cortrak insertion tracings: all 3 views available
• Cortrak guidewire available

You may not qualify if:

• Unable to speak or understand English language
• Pregnancy
• Prisoners
• FT anticipated to be removed within 24 hours
• Contraindications to placing a mark on the abdomen for top foot of receiver unit (large dressings, open abdomen, halo vest, etc.)
• Original guidewire unavailable

Sponsors & Collaborators

• Parkview Health: lead

Study Sites (1)

Parkview Regional Medical Center

Fort Wayne, Indiana, 46835, United States

Location

Related Publications (12)

• 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.

  PMID: 21527596 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.

  PMID: 27037348 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.

  PMID: 25639583 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.

  PMID: 22941709 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.

  PMID: 25900711 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.

  PMID: 11434652 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.

  PMID: 2119031 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.

  PMID: 23547123 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.

  PMID: 33130862 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.

  PMID: 28249868 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.

  PMID: 35985807 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.

  PMID: 24244058 BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

• Title: Jan Powers PhD, RN, CCNS, CCRN, CNRN, NE-BC, FCCM
• Organization: Parkview Health System

jan.powers@parkview.com

260-266-7761

Study Officials

• Jan R Powers

  Parkview Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Researcher & Nursing Research Program Coordinator

Model Details: longitudinal, repeated measures design replication study

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 2, 2024
• Study Start: March 19, 2024
• Primary Completion: August 11, 2024
• Study Completion: August 11, 2024
• Last Updated: August 11, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available after data cleaning and analysis, which is anticpated to be 10 months.
• Access Criteria: All data will be de-identified and in aggregate format.

Locations

US (1)