Feeding Disorders, Feeding Tube Complication
Conditions
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).
Interventions
DEVICENasal bridle
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)
OTHERNasal patch
Regular adhesive tape for medical use.
Sponsors
Medisch Spectrum Twente
Gelre Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The data analist who will perform the statistical analyses (TS) will be masked (i.e., will analyze groups labelled as 'A' and 'B').
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Netherlands
Contacts
Primary ContactTjard Schermer, PhD
Outcome results
None listed