An interventional study of Nasal bridle and Nasal patch in Feeding Tube Complication and Feeding Disorders, sponsored by Gelre Hospitals. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Gelre Hospitals · Not applicable, Interventional, and Supportive care
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).
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's planned enrollment of 78 is close to the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Gelre Hospitals is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Nasal bridle fixation after nasoenteral feeding tube placement.
Device: Nasal bridle
Nasal patch fixation after nasoenteral feeding tube placement.
Other: Nasal patch
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)
Regular adhesive tape for medical use.
Premature dislocation of feeding tube
Occurrence of a first premature dislocation of the feeding tube
Time frame: Within 14 days after initial placement of the feeding tube
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
Time frame: 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
Time frame: 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
Time frame: During the 14-day period after initial placement of the feeding tube
Plan to share: Yes — The IPD sharing plan has not been finished yet, scheduled for Q4 2023.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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