Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

NCT05694299 | Unknown

• 2 other identifiers: 2021_67210808 (FIXIT)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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).

Conditions

Feeding Tube Complication; Feeding Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complications related to fixation of the feeding tube

  During the 14-day period after initial placement of the feeding tube

• Pain experienced from the nasal fixation

  During the 14-day period after initial placement of the feeding tube

• Discomfort experienced from the nasal fixation

  During the 14-day period after initial placement of the feeding tube

Study Arms (2)

Nasal bridle

EXPERIMENTAL

Nasal bridle fixation after nasoenteral feeding tube placement.

Device: Nasal bridle

Nasal patch

ACTIVE COMPARATOR

Nasal patch fixation after nasoenteral feeding tube placement.

Other: Nasal patch

Interventions

Nasal bridle DEVICE

Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)

Nasal bridle

Nasal patch OTHER

Regular adhesive tape for medical use.

Nasal patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient (18 years or older)
• received a nasoenteral feeding tube while being hospitalized
• providing written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Gelre Hospitals: lead
• Medisch Spectrum Twente: collaborator

Study Sites (2)

Gelre Hospitals

Apeldoorn, Netherlands

ACTIVE NOT RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Mariël Klos

  Gelre Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tjard Schermer, PhD

CONTACT

+31(0)655102377; t.schermer@gelre.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The data analist who will perform the statistical analyses (TS) will be masked (i.e., will analyze groups labelled as 'A' and 'B').
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data are expected to become available in the course of 2024.
• Access Criteria: Will be defined as part of the IPD sharing plan, scheduled for Q4 2023.

Locations

NL (2)