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Optimal Feeding Tube Placement

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Enteral Feeding Intolerance
Interventions Device: Enteric Tube
Device: CORTRAK enteral access system
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Hide 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
Arm/Group Title Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement Total
Hide 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 Number of Baseline Participants 24 28 52
Hide Baseline Analysis Population Description
Subjects admitted to hospital requiring feeding tube placement
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 28 participants 52 participants
Age 0-1 years 14 13 27
Age 2-5 years 4 9 13
Age 6-10 years 2 2 4
Age 11-15 years 1 0 1
Age 16-18 years 3 4 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 28 participants 52 participants
Female
11
  45.8%
11
  39.3%
22
  42.3%
Male
13
  54.2%
17
  60.7%
30
  57.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 28 participants 52 participants
Hispanic 16 19 35
White 4 6 10
Asian 0 2 2
Black, African American 3 1 4
Unknown 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 28 participants 52 participants
24 28 52
1.Primary Outcome
Title Duration of Time
Hide Description Time taken for placement of enteral tube
Time Frame Baseline to End of procedure up to 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Hide 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

Overall Number of Participants Analyzed 24 28
Median (Inter-Quartile Range)
Unit of Measure: Minutes
19
(9.25 to 27.0)
2.5
(2.0 to 7.5)
2.Secondary Outcome
Title Number of X-Rays
Hide Description Number of X-rays required to achieve correct tube placement
Time Frame Baseline to End of procedure up to 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Hide 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

Overall Number of Participants Analyzed 24 28
Mean (Full Range)
Unit of Measure: x-rays
2
(1 to 4)
1
(1 to 1)
Time Frame Baseline to End of procedure (tube placement)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Hide 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 (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Blind Technique of Tube Placement CORTRAK Enteral Access System (CEAS) Placement
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prashant Jha
Organization: Children's Hospital of Nevada at UMC
Phone: 702-383-2420
EMail: prashant.jha@umcsn.com
Layout table for additonal information
Responsible Party: Andrew D. Meyer, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04241146    
Other Study ID Numbers: HSC20170704H
First Submitted: January 21, 2020
First Posted: January 27, 2020
Results First Submitted: January 25, 2020
Results First Posted: February 17, 2020
Last Update Posted: February 25, 2020