Optimal Feeding Tube Placement

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT04241146
• Collaborator: Avanos Medical (Other)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 6, 2018
• Actual Primary Completion Date: Oct 10, 2018
• Actual Study Completion Date: Nov 21, 2019

Arms and Interventions

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 Names: 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 Names: CEAS

Outcome Measures

Primary Outcome Measures

1. Duration of Time [Baseline to End of procedure up to 30 minutes]

   Time taken for placement of enteral tube

Secondary Outcome Measures

1. Number of X-Rays [Baseline to End of procedure up to 30 minutes]

   Number of X-rays required to achieve correct tube placement

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio
• Avanos Medical

Investigators

• Principal Investigator: Andrew Meyer, MD, University of Texas Health San Antonio

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 21, 2017

More Information

Publications

None provided.

• 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: Jan 27, 2020
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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, Andrew Meyer, MD, The University of Texas Health Science Center at San Antonio: enteral nutrition; radiation exposure; nursing care; pediatrics; radiation, non-ionizing

Study Results

Participant Flow

Arm/Group Title	Standard Blind Technique of Tube Placement	CORTRAK Enteral Access System (CEAS) Placement
Arm/Group Description	FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition	An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
Period Title: Overall Study
STARTED	24	28
COMPLETED	24	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Blind Technique of Tube Placement	CORTRAK Enteral Access System (CEAS) Placement	Total
Arm/Group Description	FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition	An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement	Total of all reporting groups
Overall Participants	24	28	52
Age, Customized (participants) [Number]
Age 0-1 years	14 58.3%	13 46.4%	27 51.9%
Age 2-5 years	4 16.7%	9 32.1%	13 25%
Age 6-10 years	2 8.3%	2 7.1%	4 7.7%
Age 11-15 years	1 4.2%	0 0%	1 1.9%
Age 16-18 years	3 12.5%	4 14.3%	7 13.5%
Sex: Female, Male (Count of Participants)
Female	11 45.8%	11 39.3%	22 42.3%
Male	13 54.2%	17 60.7%	30 57.7%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	16 66.7%	19 67.9%	35 67.3%
White	4 16.7%	6 21.4%	10 19.2%
Asian	0 0%	2 7.1%	2 3.8%
Black, African American	3 12.5%	1 3.6%	4 7.7%
Unknown	1 4.2%	0 0%	1 1.9%
Region of Enrollment (participants) [Number]
United States	24 100%	28 100%	52 100%

Outcome Measures

1. Primary Outcome

Title	Duration of Time
Description	Time taken for placement of enteral tube
Time Frame	Baseline to End of procedure up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Blind Technique of Tube Placement	CORTRAK Enteral Access System (CEAS) Placement
Arm/Group Description	FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition	An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
Measure Participants	24	28
Median (Inter-Quartile Range) [Minutes]	19	2.5

2. Secondary Outcome

Title	Number of X-Rays
Description	Number of X-rays required to achieve correct tube placement
Time Frame	Baseline to End of procedure up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Blind Technique of Tube Placement	CORTRAK Enteral Access System (CEAS) Placement
Arm/Group Description	FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition	An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
Measure Participants	24	28
Mean (Full Range) [x-rays]	2	1

Adverse Events

Time Frame	Baseline to End of procedure (tube placement)
Arm/Group Title	Standard Blind Technique of Tube Placement		CORTRAK Enteral Access System (CEAS) Placement
Arm/Group Description	FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition		An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
All Cause Mortality
	Standard Blind Technique of Tube Placement		CORTRAK Enteral Access System (CEAS) Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/28 (0%)
Serious Adverse Events
	Standard Blind Technique of Tube Placement		CORTRAK Enteral Access System (CEAS) Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Standard Blind Technique of Tube Placement		CORTRAK Enteral Access System (CEAS) Placement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.