Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes

• ClinicalTrials.gov Identifier: NCT03966157
• Recruitment Status: Recruiting
• First Posted: May 29, 2019
• Last Update Posted: June 18, 2020
• Sponsor: St. Louis University
• Information provided by (Responsible Party): Florence0Damilola Odufalu, MD, St. Louis University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Feeding Disorders	Device: Nasal Bridle	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-enteric Tube Placement
• Actual Study Start Date: June 19, 2019
• Estimated Primary Completion Date: May 30, 2021
• Estimated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nasal Bridle; Patients randomized to have nasal bridle.	Device: Nasal Bridle; Feeding tube secured with nasal bridle
No Intervention: Standard; Patients randomized with adhesive tape.

Outcome Measures

Primary Outcome Measures :

1. Number of participants that need repeat endoscopy to replace dislodged feeding tubes, nasal bridle [ Time Frame: 12 months ]
   Number of participants that need repeat endoscopy to replace dislodged feeding tubes, nasal bridle

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patients in need for endoscopically placed nasoenteric feeding tube

Exclusion Criteria:

• Age greater than 90 years

Contacts and Locations

Contacts

Contact: Odufalu; 573-577-8764; florence.odufalu@health.slu.edu

Locations

United States, Missouri

Saint Louis University Hospital; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Odufalu 573-577-8764 florence.odufalu@health.slu.edu

Sponsors and Collaborators

St. Louis University

More Information

• Responsible Party: Florence0Damilola Odufalu, MD, Principal Investigator, St. Louis University
• ClinicalTrials.gov Identifier: NCT03966157
• Other Study ID Numbers: 29703
• First Posted: May 29, 2019
• Last Update Posted: June 18, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Feeding and Eating Disorders; Mental Disorders