Trial Outcomes & Findings for Optimal Feeding Tube Placement (NCT NCT04241146)
NCT ID: NCT04241146
Last Updated: 2020-02-25
Results Overview
Time taken for placement of enteral tube
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline to End of procedure up to 30 minutes
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Feeding Tube Placement
Baseline characteristics by cohort
| Measure |
Standard Blind Technique of Tube Placement
n=24 Participants
FDA approved technique of enteral nutrition tube placement
Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition
|
CORTRAK Enteral Access System (CEAS) Placement
n=28 Participants
An electromagnetic device used to enable enteral nutrition tube placement
CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 0-1 years
|
14 participants
n=39 Participants
|
13 participants
n=41 Participants
|
27 participants
n=35 Participants
|
|
Age, Customized
Age 2-5 years
|
4 participants
n=39 Participants
|
9 participants
n=41 Participants
|
13 participants
n=35 Participants
|
|
Age, Customized
Age 6-10 years
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Age, Customized
Age 11-15 years
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Age, Customized
Age 16-18 years
|
3 participants
n=39 Participants
|
4 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 participants
n=39 Participants
|
19 participants
n=41 Participants
|
35 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=39 Participants
|
6 participants
n=41 Participants
|
10 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=39 Participants
|
2 participants
n=41 Participants
|
2 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black, African American
|
3 participants
n=39 Participants
|
1 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=39 Participants
|
28 participants
n=41 Participants
|
52 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of procedure up to 30 minutesTime taken for placement of enteral tube
Outcome measures
| Measure |
Standard Blind Technique of Tube Placement
n=24 Participants
FDA approved technique of enteral nutrition tube placement
Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition
|
CORTRAK Enteral Access System (CEAS) Placement
n=28 Participants
An electromagnetic device used to enable enteral nutrition tube placement
CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
|
|---|---|---|
|
Duration of Time
|
19 Minutes
Interval 9.25 to 27.0
|
2.5 Minutes
Interval 2.0 to 7.5
|
SECONDARY outcome
Timeframe: Baseline to End of procedure up to 30 minutesNumber of X-rays required to achieve correct tube placement
Outcome measures
| Measure |
Standard Blind Technique of Tube Placement
n=24 Participants
FDA approved technique of enteral nutrition tube placement
Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition
|
CORTRAK Enteral Access System (CEAS) Placement
n=28 Participants
An electromagnetic device used to enable enteral nutrition tube placement
CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement
|
|---|---|---|
|
Number of X-Rays
|
2 x-rays
Interval 1.0 to 4.0
|
1 x-rays
Interval 1.0 to 1.0
|
Adverse Events
Standard Blind Technique of Tube Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CORTRAK Enteral Access System (CEAS) Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place