Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Study Overview
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Brief Summary
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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).

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

Conditions
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Feeding Tube Complication, Feeding Disorders

Intervention / Treatment
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* Device: Nasal bridle
* Other: Nasal patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal bridle<br>Nasal bridle fixation after nasoenteral feeding tube placement. | Device: Nasal bridle<br>* Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)<br>|
| Active Comparator: Nasal patch<br>Nasal patch fixation after nasoenteral feeding tube placement. | Other: Nasal patch<br>* Regular adhesive tape for medical use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |