Trial Outcomes & Findings for Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes (NCT NCT03966157)
NCT ID: NCT03966157
Last Updated: 2023-05-19
Results Overview
The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
12 months
Results posted on
2023-05-19
Participant Flow
Participant milestones
| Measure |
Nasal Bridle
Patients randomized to have nasal bridle.
Nasal Bridle: Feeding tube secured with nasal bridle
|
Standard
Patients randomized with adhesive tape.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nasal Bridle
Patients randomized to have nasal bridle.
Nasal Bridle: Feeding tube secured with nasal bridle
|
Standard
Patients randomized with adhesive tape.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nasal Bridle
n=16 Participants
Patients randomized to have nasal bridle.
Nasal Bridle: Feeding tube secured with nasal bridle
|
Standard
n=14 Participants
Patients randomized with adhesive tape.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=16 Participants
|
11 Participants
n=14 Participants
|
24 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=16 Participants
|
3 Participants
n=14 Participants
|
6 Participants
n=30 Participants
|
|
Age, Continuous
|
54.8 years
n=16 Participants
|
53.4 years
n=14 Participants
|
54.0 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=16 Participants
|
7 Participants
n=14 Participants
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=16 Participants
|
7 Participants
n=14 Participants
|
14 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
14 participants
n=14 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One patient randomized to nasal bridle completed procedure but was lost to follow-up
The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement
Outcome measures
| Measure |
Nasal Bridle
n=15 Participants
Patients randomized to have nasal bridle.
Nasal Bridle: Feeding tube secured with nasal bridle
|
Standard
n=14 Participants
Patients randomized with adhesive tape.
|
|---|---|---|
|
Repeat Endoscopy to Replace Dislodged Feeding Tube
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants that inadvertently have nasoenteric tube dislodged
Outcome measures
| Measure |
Nasal Bridle
n=15 Participants
Patients randomized to have nasal bridle.
Nasal Bridle: Feeding tube secured with nasal bridle
|
Standard
n=14 Participants
Patients randomized with adhesive tape.
|
|---|---|---|
|
Inadvertent Tube Dislodgement
|
7 Participants
|
2 Participants
|
Adverse Events
Nasal Bridle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
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