Enteral Feeding Intolerance
Conditions
Keywords
enteral nutrition, radiation exposure, nursing care, pediatrics, radiation, non-ionizing
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.
Interventions
DEVICEEnteric Tube
A post pyloric feeding tube used in patients requiring enteral nutrition
DEVICECORTRAK enteral access system
Electromagnetic guidance system for enteric feeding tube placement
Sponsors
Avanos Medical
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Time | Baseline to End of procedure up to 30 minutes | Time taken for placement of enteral tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of X-Rays | Baseline to End of procedure up to 30 minutes | Number of X-rays required to achieve correct tube placement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Blind Technique of Tube Placement FDA approved technique of enteral nutrition tube placement
Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition | 24 |
| CORTRAK Enteral Access System (CEAS) Placement An electromagnetic device used to enable enteral nutrition tube placement
CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement | 28 |
| Total | 52 |
Baseline characteristics
| Characteristic | CORTRAK Enteral Access System (CEAS) Placement | Total | Standard Blind Technique of Tube Placement |
|---|---|---|---|
| Age, Customized Age 0-1 years | 13 participants | 27 participants | 14 participants |
| Age, Customized Age 11-15 years | 0 participants | 1 participants | 1 participants |
| Age, Customized Age 16-18 years | 4 participants | 7 participants | 3 participants |
| Age, Customized Age 2-5 years | 9 participants | 13 participants | 4 participants |
| Age, Customized Age 6-10 years | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Black, African American | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 19 participants | 35 participants | 16 participants |
| Race/Ethnicity, Customized Unknown | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 6 participants | 10 participants | 4 participants |
| Region of Enrollment United States | 28 participants | 52 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 17 Participants | 30 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 28 |
| other Total, other adverse events | 0 / 24 | 0 / 28 |
| serious Total, serious adverse events | 0 / 24 | 0 / 28 |
Outcome results
Primary
Duration of Time
Time taken for placement of enteral tube
Time frame: Baseline to End of procedure up to 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Blind Technique of Tube Placement | Duration of Time | 19 Minutes |
| CORTRAK Enteral Access System (CEAS) Placement | Duration of Time | 2.5 Minutes |
Secondary
Number of X-Rays
Number of X-rays required to achieve correct tube placement
Time frame: Baseline to End of procedure up to 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Blind Technique of Tube Placement | Number of X-Rays | 2 x-rays |
| CORTRAK Enteral Access System (CEAS) Placement | Number of X-Rays | 1 x-rays |