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Optimal Feeding Tube Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241146
Recruitment Status : Completed
First Posted : January 27, 2020
Results First Posted : February 17, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Avanos Medical
Information provided by (Responsible Party):
Andrew D. Meyer, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE January 27, 2020
Results First Submitted Date  ICMJE January 25, 2020
Results First Posted Date  ICMJE February 17, 2020
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE January 6, 2018
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
Duration of Time [ Time Frame: Baseline to End of procedure up to 30 minutes ]
Time taken for placement of enteral tube
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
Duration of Time [ Time Frame: Baseline to End of procedure ]
Time taken for placement of enteral tube
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
Number of X-Rays [ Time Frame: Baseline to End of procedure up to 30 minutes ]
Number of X-rays required to achieve correct tube placement
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
Number of X-Rays [ Time Frame: Baseline to End of procedure ]
Number of X-rays required to achieve correct tube placement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Feeding Tube Placement
Official Title  ICMJE A Randomized Controlled Trial for Optimal Feeding Tube Placement
Brief Summary A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.
Detailed Description Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Enteral Feeding Intolerance
Intervention  ICMJE
  • Device: Enteric Tube
    A post pyloric feeding tube used in patients requiring enteral nutrition
    Other Name: Enteral nutrition tube
  • Device: CORTRAK enteral access system
    Electromagnetic guidance system for enteric feeding tube placement
    Other Name: CEAS
Study Arms  ICMJE
  • Active Comparator: Standard Blind Technique of Tube placement
    FDA approved technique of enteral nutrition tube placement
    Intervention: Device: Enteric Tube
  • Active Comparator: CORTRAK enteral access system (CEAS) placement
    An electromagnetic device used to enable enteral nutrition tube placement
    Intervention: Device: CORTRAK enteral access system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2020)
52
Original Actual Enrollment  ICMJE
 (submitted: January 23, 2020)
53
Actual Study Completion Date  ICMJE November 21, 2019
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria

Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241146
Other Study ID Numbers  ICMJE HSC20170704H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.
Supporting Materials: Study Protocol
Time Frame: Data will be available after primary manuscript is accepted for publication.
Access Criteria: Data will be available in journal publication
Responsible Party Andrew D. Meyer, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Avanos Medical
Investigators  ICMJE
Principal Investigator: Andrew Meyer, MD University of Texas Health San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP