FIXIT: Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes

Sponsor

Gelre Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT05694299

Collaborator

Medisch Spectrum Twente (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Feeding Tube Complication Feeding Disorders	Device: Nasal bridle Other: Nasal patch	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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').

Primary Purpose:

Supportive Care

Official Title:

Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Premature dislocation of feeding tube [Within 14 days after initial placement of the feeding tube]
Occurrence of a first premature dislocation of the feeding tube

Secondary Outcome Measures

Complications related to fixation of the feeding tube [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
Pain experienced from the nasal fixation [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
Discomfort experienced from the nasal fixation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gelre Hospitals	Apeldoorn		Netherlands
2	Medisch Spectrum Twente	Enschede		Netherlands

Sponsors and Collaborators

Gelre Hospitals
Medisch Spectrum Twente

Investigators

Principal Investigator: Mariël Klos, Gelre Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gelre Hospitals

ClinicalTrials.gov Identifier:

NCT05694299

Other Study ID Numbers:

2021_67
210808 (FIXIT)

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Feeding and Eating Disorders

Study Results

No Results Posted as of Jan 25, 2023