Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes

NCT03966157 | Completed Results DMC FDA Device

• 1 other identifier: 29703
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

• Inadvertent Tube Dislodgement

  12 months

Study Arms (2)

Nasal Bridle

EXPERIMENTAL

Patients randomized to have nasal bridle.

Device: Nasal Bridle

Standard

NO INTERVENTION

Patients randomized with adhesive tape.

Interventions

Nasal Bridle DEVICE

Feeding tube secured with nasal bridle

Nasal Bridle

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need for endoscopically placed nasoenteric feeding tube

You may not qualify if:

• Age greater than 90 years

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Samuel Burton

St Louis, Missouri, 63109, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Dr. Samuel J. Burton
• Organization: Saint Louis University

s.burton.1818@gmail.com

3147500811

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: June 19, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)