Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes (FIXIT)

Gelre Hospitals

Status: Enrolling

Conditions: Feeding Tube Complication; Feeding Disorders

Treatments: Device: Nasal bridle; Other: Nasal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05694299

2021_67

210808 (FIXIT) (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Nasal bridle

Experimental group

Description:

Nasal bridle fixation after nasoenteral feeding tube placement.

Treatment:

Device: Nasal bridle

Nasal patch

Active Comparator group

Description:

Nasal patch fixation after nasoenteral feeding tube placement.

Treatment:

Other: Nasal patch