DrIFT 2 Study: Displacement in Feeding Tubes

February 1, 2024 updated by: Danielle Payne, FNP, Parkview Health
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46835
        • Parkview Regional Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Janette Richardson, MSN
        • Principal Investigator:
          • Jan Powers, PhD
        • Sub-Investigator:
          • Jennifer Rechter, MSN
        • Sub-Investigator:
          • Elaine Petite, ASN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: electromagnetic placement device
Daily use of an EMPD to verify FT position
Other Names:
  • Cortrak* 2 Enteral Access System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tube migration
Time Frame: 5 days or until FT removed, whichever came first
Number of participants with small bore feeding tube migration
5 days or until FT removed, whichever came first
Time of FT migration
Time Frame: 5 days or until FT removed, whichever came first
Number of hours from insertion to tube movement in participants with FT migration
5 days or until FT removed, whichever came first
Migration direction
Time Frame: 5 days or until FT removed, whichever came first
Number of participants with forward migration/backward migration
5 days or until FT removed, whichever came first
FT distal tip zone
Time Frame: 5 days or until FT removed, whichever came first
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkview Health

Investigators

  • Principal Investigator: Jan R Powers, Parkview Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NUR23-1127DrIFT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available after data cleaning and analysis, which is anticpated to be 10 months.

IPD Sharing Access Criteria

All data will be de-identified and in aggregate format.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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