DrIFT 2 Study: Displacement in Feeding Tubes

Enteral Nutrition Clinical Trial

Official title:

DrIFT 2 Study: Displacement in Feeding Tubes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239610
• Other study ID #: NUR23-1127DrIFT2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Parkview Health
• Contact: Jan Powers, PhD
• Phone: 260.266.7761
• Email: Jan.powers[@]parkview.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Device:
• electromagnetic placement device
Daily use of an EMPD to verify FT position

Locations

Country	Name	City	State
United States	Parkview Regional Medical Center	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Parkview Health

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tube migration	Number of participants with small bore feeding tube migration	5 days or until FT removed, whichever came first
Primary	Time of FT migration	Number of hours from insertion to tube movement in participants with FT migration	5 days or until FT removed, whichever came first
Primary	Migration direction	Number of participants with forward migration/backward migration	5 days or until FT removed, whichever came first
Primary	FT distal tip zone	Zone of the FT distal tip in participants as measured by Cortrak 2 Enteral Access System	5 days or until FT removed, whichever came first