Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Feeding Disorders Clinical Trial

— FIXIT  

Official title:

Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694299
• Other study ID #: 2021_67
• Secondary ID: 210808 (FIXIT)
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Gelre Hospitals
• Contact: Tjard Schermer, PhD
• Phone: +31(0)655102377
• Email: t.schermer[@]gelre.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 * 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient (18 years or older)
• received a nasoenteral feeding tube while being hospitalized
• providing written informed consent

Exclusion Criteria:

• contraindication for a nasal bridle (e.g., cleft lip or damaged nasal mucosa)
• clinical need to place a nasal bridle
• anticipated feeding nasoenteral feeding tube placement for < 3 days
• failure of nasoenteral feeding tube placement

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorders
• Feeding Tube Complication

Intervention

Device:
• Nasal bridle
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)

Other:
• Nasal patch
Regular adhesive tape for medical use.

Locations

Country	Name	City	State
Netherlands	Gelre Hospitals	Apeldoorn
Netherlands	Medisch Spectrum Twente	Enschede

Sponsors (2)

Lead Sponsor	Collaborator
Gelre Hospitals	Medisch Spectrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature dislocation of feeding tube	Occurrence of a first premature dislocation of the feeding tube	Within 14 days after initial placement of the feeding tube
Secondary	Complications related to fixation of the feeding tube	Occurence of nasal pressure ulcer (grade and location); sinusitis (running nose; nasal congestion); facial pain or pressure; dysosmia; frequent sneezing; epistaxis	During the 14-day period after initial placement of the feeding tube
Secondary	Pain experienced from the nasal fixation	Pain scored on a visual analogue scale (VAS) with a minimum score of 0 and a maximum score of 100	During the 14-day period after initial placement of the feeding tube
Secondary	Discomfort experienced from the nasal fixation	Discomfort scored on a visual analogue scale (VAS) with a minimum score of 0 and a maximum score of 100	During the 14-day period after initial placement of the feeding tube