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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

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.

Condition or disease Intervention/treatment Phase
Enteral Feeding Intolerance Device: Enteric Tube Device: CORTRAK enteral access system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for Optimal Feeding Tube Placement
Actual Study Start Date : January 6, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : November 21, 2019

Arm Intervention/treatment
Active Comparator: Standard Blind Technique of Tube placement
FDA approved technique of enteral nutrition tube placement
Device: Enteric Tube
A post pyloric feeding tube used in patients requiring enteral nutrition
Other Name: Enteral nutrition tube

Active Comparator: CORTRAK enteral access system (CEAS) placement
An electromagnetic device used to enable enteral nutrition tube placement
Device: CORTRAK enteral access system
Electromagnetic guidance system for enteric feeding tube placement
Other Name: CEAS




Primary Outcome Measures :
  1. Duration of Time [ Time Frame: Baseline to End of procedure up to 30 minutes ]
    Time taken for placement of enteral tube


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241146


Locations
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United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Avanos Medical
Investigators
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Principal Investigator: Andrew Meyer, MD University of Texas Health San Antonio
  Study Documents (Full-Text)

Documents provided by Andrew D. Meyer, The University of Texas Health Science Center at San Antonio:
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Responsible Party: Andrew D. Meyer, Andrew Meyer, MD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04241146    
Other Study ID Numbers: HSC20170704H
First Posted: January 27, 2020    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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

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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
Keywords provided by Andrew D. Meyer, The University of Texas Health Science Center at San Antonio:
enteral nutrition
radiation exposure
nursing care
pediatrics
radiation, non-ionizing