Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Not Applicable

Recruiting

• Conditions: Feeding Tube Complication; Feeding Disorders
• Interventions: Device: Nasal bridle; Other: Nasal patch

• Registration Number: NCT05694299
• Lead Sponsor: Gelre Hospitals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal bridle	Nasal bridle	Nasal bridle fixation after nasoenteral feeding tube placement.
Nasal patch	Nasal patch	Nasal patch fixation after nasoenteral feeding tube placement.

Primary Outcome Measures

Name	Time	Method
Premature dislocation of feeding tube	Within 14 days after initial placement of the feeding tube	Occurrence of a first premature dislocation of the feeding tube

Secondary Outcome Measures

Name	Time	Method
Pain experienced from the nasal fixation	During the 14-day period after initial placement of the feeding tube	Pain scored on a visual analogue scale (VAS) with a minimum score of 0 and a maximum score of 100
Discomfort experienced from the nasal fixation	During the 14-day period after initial placement of the feeding tube	Discomfort scored on a visual analogue scale (VAS) with a minimum score of 0 and a maximum score of 100
Complications related to fixation of the feeding tube	During the 14-day period after initial placement 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

Trial Locations

Locations (2)

Gelre Hospitals; 🇳🇱 Apeldoorn, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands