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

Primary Purpose

Feeding Tube Complication, Feeding Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nasal bridle
Nasal patch
Sponsored by
Gelre Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Feeding Tube Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gelre Hospitals
  • Medisch Spectrum TwenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasal bridle

Nasal patch

Arm Description

Nasal bridle fixation after nasoenteral feeding tube placement.

Nasal patch fixation after nasoenteral feeding tube placement.

Outcomes

Primary Outcome Measures

Premature dislocation of feeding tube
Occurrence of a first premature dislocation of the feeding tube

Secondary Outcome Measures

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
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
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

Full Information

First Posted
January 12, 2023
Last Updated
January 20, 2023
Sponsor
Gelre Hospitals
Collaborators
Medisch Spectrum Twente
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1. Study Identification

Unique Protocol Identification Number
NCT05694299
Brief Title
Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes
Acronym
FIXIT
Official Title
Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gelre Hospitals
Collaborators
Medisch Spectrum Twente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Tube Complication, Feeding Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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').
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal bridle
Arm Type
Experimental
Arm Description
Nasal bridle fixation after nasoenteral feeding tube placement.
Arm Title
Nasal patch
Arm Type
Active Comparator
Arm Description
Nasal patch fixation after nasoenteral feeding tube placement.
Intervention Type
Device
Intervention Name(s)
Nasal bridle
Intervention Description
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)
Intervention Type
Other
Intervention Name(s)
Nasal patch
Intervention Description
Regular adhesive tape for medical use.
Primary Outcome Measure Information:
Title
Premature dislocation of feeding tube
Description
Occurrence of a first premature dislocation of the feeding tube
Time Frame
Within 14 days after initial placement of the feeding tube
Secondary Outcome Measure Information:
Title
Complications related to fixation of the feeding tube
Description
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
Title
Pain experienced from the nasal fixation
Description
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
Title
Discomfort experienced from the nasal fixation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tjard Schermer, PhD
Phone
+31(0)655102377
Email
t.schermer@gelre.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariël Klos
Organizational Affiliation
Gelre Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelre Hospitals
City
Apeldoorn
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariël Klos
Phone
+31(0)640973307
Email
mariel.klos@MST.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

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