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

January 20, 2023 updated by: Gelre Hospitals

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Apeldoorn, Netherlands
        • Active, not recruiting
        • Gelre Hospitals
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasal bridle
Nasal bridle fixation after nasoenteral feeding tube placement.
Device: Nasal bridle
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)
Active Comparator: Nasal patch
Nasal patch fixation after nasoenteral feeding tube placement.
Other: Nasal patch
Regular adhesive tape for medical use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature dislocation of feeding tube
Time Frame: Within 14 days after initial placement of the feeding tube
Occurrence of a first premature dislocation of the feeding tube
Within 14 days after initial placement of the feeding tube

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications related to fixation of the feeding tube
Time Frame: 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
During the 14-day period after initial placement of the feeding tube
Pain experienced from the nasal fixation
Time Frame: 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
During the 14-day period after initial placement of the feeding tube
Discomfort experienced from the nasal fixation
Time Frame: 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
During the 14-day period after initial placement of the feeding tube

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gelre Hospitals

Collaborators

Medisch Spectrum Twente

Investigators

  • Principal Investigator: Mariël Klos, Gelre Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_67
  • 210808 (FIXIT) (Other Identifier: Medical Ethics Committee Isala Zwolle The Netherlands)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The IPD sharing plan has not been finished yet, scheduled for Q4 2023.

IPD Sharing Time Frame

Data are expected to become available in the course of 2024.

IPD Sharing Access Criteria

Will be defined as part of the IPD sharing plan, scheduled for Q4 2023.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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