Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03966157 |
| Other study ID # |
29703 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 19, 2019 |
| Est. completion date |
March 25, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
St. Louis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In critically ill patients, nutrition is a major part of healing and recovery. In patients
unable to tolerate oral feeding, nasoenteric tube feeding (a tube placed from the nose to the
stomach or small intestine) provides a safe alternative for feeding. Some patients require
these tubes to be placed endoscopically due to numerous patient factors including difficult
anatomy, need for post-gastric feeding, among others). In patients that require
endoscopically placed tubes, there is risk of perforation, infection, bleeding, aspiration,
and rarely even death. In patients that have recurrent dislodgement of endoscopically placed
tubes, the need for repeat endoscopy increases patient exposure to these risks. Traditional
securing mechanism with adhesive tape to reduce dislodgment often fail in critically ill
patients requiring patients to have repeat endoscopies to replace nasoenteric feeding tubes
and subjects patients potentially to increased cumulative risks associated with each
endoscopy.
The investigators propose to collect data for one year, the investigators will prospectively
follow via chart review endoscopically placed naso-enteric tubes placed with a Standard AMT
Bridle securement device and assess if there is a reduction in accidental tube removal
requiring replacement endoscopically.
Description:
Patients to be recruited are those who are scheduled to undergo routine upper endoscopy with
nasoenteric tube placement. Patients will be randomized into two groups: control arm and
device arm.
Control arm includes patients that will have nasoenteric tubes secured with standard
protocol, adhesive tape. Device arm includes patients that will have nasoenteric tubes
secured with Standard AMT Bridle. The nasal bridles will be placed by the endoscopist. Upper
endoscopy will not be affected. Placement of nasal bridle will take 1-2 minutes after
endoscopic procedure completed. No addition sedation, medication or exposure necessary.
Patients will be randomized by sealed envelope randomization. Clinicians are given randomly
generated treatment allocations within sealed opaque envelopes. Once a patient has consented
to enter the study trial an envelope is opened and the patient is then offered the allocated
treatment regimen. Patients will be consented by a member of the research team prior to
endoscopy. Randomization will be singly blinded only to the the patient prior to endoscopy.
Endoscopist will not be blinded as they will be placing the securement device and in order to
reduce selection bias.
In the event of tube dislodgment, the patient will receive same treatment.
Follow-up of patients will occur via chart review until the time of discharge, at 6 months
and at 12 months after feeding tube placement via chart review. Data collected with include
repeat EGD, length of endoscopy, length of hospital stay, and mortality. The number of
endoscopies and repeated nasoenteric tubes placed will be tracked at six and twelve months.
