Enteral NutritionNCT06239610
DrIFT 2 Study: Displacement in Feeding Tubes
A study testing electromagnetic placement device in people with Enteral Nutrition, run by Parkview Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- electromagnetic placement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 11 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkview Regional Medical Center
Fort Wayne, Indiana, 46835
About this study
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.
Read the detailed 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.
- Conditions
- Enteral Nutrition
- Being tested
- electromagnetic placement device
- Keywords
- feeding tube, coretrak, tube migration, critical care, enteral nutrition, gastric tube feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnetic placement deviceDevice
Also called Cortrak* 2 Enteral Access System
Daily use of an EMPD to verify FT position
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: electromagnetic placement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube Migration
Number of participants with clincially significant feeding tube retrograde migration
Measured: 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
Measured: 5 days or until FT removed, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Mar 2024
- Primary completion11 Aug 2024
- Study completion11 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- longitudinal, repeated measures design replication study
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkview Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Payne, FNP, Parkview Health
- Investigators
- Jan R Powers, Principal investigator, Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239610
- Sponsor's protocol ID
- NUR23-1127DrIFT2
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2024
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21527596Initial 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.
PubMed 27037348Bourgault 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.
PubMed 25639583Metheny 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.
PubMed 22941709Milsom 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.
PubMed 25900711Kearns 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.
PubMed 11434652Metheny 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.
PubMed 2119031Makic 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.
PubMed 23547123Bourgault 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.
PubMed 33130862Bourgault 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.
PubMed 28249868Bourgault 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.
PubMed 35985807Wang 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.
PubMed 24244058
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DrIFT 2 Study: Displacement in Feeding Tubes
- ClinicalTrials.gov ID
- NCT06239610
- Acronym / sponsor ID
- NUR23-1127DrIFT2
- Conditions
- Enteral Nutrition
- Keywords
- feeding tube, coretrak, tube migration, critical care, enteral nutrition, gastric tube feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Parkview HealthUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 11 Aug 2024 (actual)
- Study completion
- 11 Aug 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- longitudinal, repeated measures design replication study
| Arm | Type | Receives |
|---|---|---|
| feeding tube migration | Other | Device: electromagnetic placement deviceUse of an EMPD to assess for FT migration in all eligible critical care patients requiring the use of a feeding tube during admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromagnetic placement deviceAlso: Cortrak* 2 Enteral Access SystemDaily use of an EMPD to verify FT position | Device | feeding tube migration |
Primary outcome
Tube Migration
Time frame: 5 days or until FT removed, whichever came first
Number of participants with clincially significant feeding tube retrograde migration
Effect of ETT Extubation on FT Movement
Time frame: 5 days or until FT removed, whichever came first
Number of participants with clincially significant retrograde migration after extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21527596Metheny 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.
- Background: PubMed 27037348Initial 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.
- Background: PubMed 25639583Bourgault 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.
- Background: PubMed 22941709Metheny 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.
- Background: PubMed 25900711Milsom 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.
- Background: PubMed 11434652Kearns 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.
- Background: PubMed 2119031Metheny 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.
- Background: PubMed 23547123Makic 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.
- Background: PubMed 33130862Bourgault 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.
- Background: PubMed 28249868Bourgault 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.
- Background: PubMed 35985807Bourgault 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.
- Background: PubMed 24244058Wang 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan R Powers principal investigator
Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnetic placement device in people with Enteral Nutrition, run by Parkview Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tube Migration (time frame: 5 days or until FT removed, whichever came first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239610, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.