An interventional study of Nasal Bridle in Feeding Disorders, sponsored by St. Louis University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by St. Louis University · Not applicable, Interventional, and Prevention
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.
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.
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's enrollment of 31 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to have nasal bridle.
Device: Nasal Bridle
Patients randomized with adhesive tape.
Feeding tube secured with nasal bridle
Repeat Endoscopy to Replace Dislodged Feeding Tube
The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement
Time frame: 12 months
Inadvertent Tube Dislodgement
Number of participants that inadvertently have nasoenteric tube dislodged
Time frame: 12 months
| Milestone | Nasal Bridle | Standard |
|---|---|---|
| Started | 17 | 14 |
| Completed | 16 | 14 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement
| Participants | Nasal Bridle | Standard |
|---|---|---|
| Repeat Endoscopy to Replace Dislodged Feeding Tube | 3 | 2 |
Number of participants that inadvertently have nasoenteric tube dislodged
| Participants | Nasal Bridle | Standard |
|---|---|---|
| Inadvertent Tube Dislodgement | 7 | 2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasal Bridle | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Standard | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
One patient randomized to nasal bridle, but did not complete study as there was change in clinical status
| Age, Categorical(Participants) | Nasal Bridle | Standard | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 11 | 24 |
| >=65 years | 3 | 3 | 6 |
| Age, Continuous(years) | Nasal Bridle | Standard | Total |
|---|---|---|---|
| Mean | 54.8 (18 to 77) | 53.4 (31 to 82) | 54.0 (18 to 82) |
| Sex: Female, Male(Participants) | Nasal Bridle | Standard | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 7 | 7 | 14 |
| Race and Ethnicity Not Collected(Participants) | Nasal Bridle | Standard | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Nasal Bridle | Standard | Total |
|---|---|---|---|
| United States | 16 | 14 | 30 |
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Plan to share: No
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