Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes
Condition: Feeding Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Nasal Bridle
Intervention type(s): Device
Intervention description(s): Feeding tube secured with nasal bridle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention