The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-enteric Tube Placement
Phase: NA
Conditions: Feeding Disorders
Sponsor: St. Louis University

Title: The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-
enteric Tube Placement 
ClincalTrials.gov ID: NCT03966157 
DocumentaƟon upload date: 3/22/2023 
IniƟal IRB approval date: 06/13/2019 
Brief Summary:  
In criƟcally ill paƟents, nutriƟon is a major part of healing and recovery. In paƟents unable to tolerate 
oral feeding, nasoenteric tube feeding (a tube placed from the nose to the stomach or small intesƟne) 
provides a safe alternaƟve for feeding. Some paƟents require these tubes to be placed endoscopically 
due to numerous paƟent factors including diﬃcult anatomy, need for post-gastric feeding, among 
others). In paƟents that require endoscopically placed tubes, there is risk of perforaƟon, infecƟon, 
bleeding, aspiraƟon, and rarely even death. In paƟents that have recurrent dislodgement of 
endoscopically placed tubes, the need for repeat endoscopy increases paƟent exposure to these risks. 
TradiƟonal securing mechanism with adhesive tape to reduce dislodgment oŌen fail in criƟcally ill 
paƟents requiring paƟents to have repeat endoscopies to replace nasoenteric feeding tubes and subjects 
paƟents potenƟally to increased cumulaƟve risks associated with each endoscopy. 
The invesƟgators propose to collect data for one year, the invesƟgators will prospecƟvely follow via chart 
review endoscopically placed nasoenteric tubes placed with a Standard AMT Bridle securement device 
and assess if there is a reducƟon in accidental tube removal requiring replacement endoscopically. 
 
Outcomes: 
Primary objecƟve is to see if nasal bridles versus standard adhesive tape to secure nasoenteric tubes 
decreases the need for repeat endoscopy to replace dislodged nasoenteric tubes. The number of 
endoscopies and repeated nasoenteric tubes placed will be tracked at six and twelve months. Secondary 
objecƟves can assess if reduces tube dislodgement frequency. Hypothesis: We hypothesize that nasal 
bridles in endoscopically placed feeding tubes will reduce the number of unnecessary endoscopies 
reducing health care costs and complicaƟons. 
Detailed DescripƟon: 
 
PaƟents to be recruited are those who are scheduled to undergo rouƟne upper endoscopy with 
nasoenteric tube placement. PaƟents will be randomized into two groups: control arm and device arm. 
Control arm includes paƟents that will have nasoenteric tubes secured with standard protocol, adhesive 
tape. Device arm includes paƟents 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 aŌer endoscopic procedure completed. No addiƟon sedaƟon, 
medicaƟon or exposure necessary. 
PaƟents will be randomized by sealed envelope randomizaƟon. Clinicians are given randomly generated 
treatment allocaƟons within sealed opaque envelopes. Once a paƟent has consented to enter the study 

trial an envelope is opened and the paƟent is then oﬀered the allocated treatment regimen. PaƟents will 
be consented by a member of the research team prior to endoscopy. RandomizaƟon will be singly 
blinded only to the paƟent prior to endoscopy. Endoscopist will not be blinded as they will be placing the 
securement device and in order to reduce selecƟon bias. 
In the event of tube dislodgment, the paƟent will receive same treatment. 
Follow-up of paƟents will occur via chart review unƟl the Ɵme of discharge, at 6 months and at 12 
months aŌer 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. 
 
StaƟcal Analysis 
DescripƟve staƟsƟcs (means, medians, percentage) will be used to deﬁne the paƟent characterisƟcs. Chi-
square will be used for categorical variables. T-test will be used to analyze conƟnuous variables.