Feeding Disorders Clinical Trial
— FIXITOfficial title:
Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial
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).
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Gelre Hospitals | Apeldoorn | |
Netherlands | Medisch Spectrum Twente | Enschede |
Lead Sponsor | Collaborator |
---|---|
Gelre Hospitals | Medisch Spectrum Twente |
Netherlands,
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 |
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