Feeding DisordersNCT03966157
Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes
A study testing Nasal Bridle in people with Feeding Disorders, run by St. Louis University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Disorders
- What is being tested?
- Nasal Bridle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in need for endoscopically placed nasoenteric feeding tube
Who cannot join
- Age greater than 90 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-enteric Tube Placement
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.
Read the detailed 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.
- Conditions
- Feeding Disorders
- Being tested
- Nasal Bridle
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal BridleDevice
Feeding tube secured with nasal bridle
| Study group | Role | What they receive |
|---|---|---|
| Nasal Bridle | Experimental | Patients randomized to have nasal bridle. Receives: Device: Nasal Bridle |
| Standard | No intervention | Patients randomized with adhesive tape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Inadvertent Tube Dislodgement
Number of participants that inadvertently have nasoenteric tube dislodged
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start19 Jun 2019
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Feeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Burton, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966157
- Sponsor's protocol ID
- 29703
- Status last verified
- May 2023
- First submitted
- 22 May 2019
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-enteric Tube Placement
- ClinicalTrials.gov ID
- NCT03966157
- Acronym / sponsor ID
- 29703
- Conditions
- Feeding Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Bridle | Experimental | Device: Nasal BridlePatients randomized to have nasal bridle. |
| Standard | No intervention | –Patients randomized with adhesive tape. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in need for endoscopically placed nasoenteric feeding tube
Key exclusion criteria (1 listed)
- Age greater than 90 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal BridleFeeding tube secured with nasal bridle | Device | Nasal Bridle |
Primary outcome
Repeat Endoscopy to Replace Dislodged Feeding Tube
Time frame: 12 months
The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement
1 secondary outcome
Inadvertent Tube Dislodgement
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Feeding Disorders
Active, not recruiting
Parent Tube Weaning Interviews
Feeding Difficulties, Remote Patient Monitoring
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Bridle in people with Feeding Disorders, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeat Endoscopy to Replace Dislodged Feeding Tube (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.