Feeding Tube ComplicationFIXITNCT05694299
Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes
A study testing Nasal bridle and Nasal patch in people with Feeding Tube Complication and Feeding Disorders, run by Gelre Hospitals at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feeding Tube Complication, Feeding Disorders
- What is being tested?
- Nasal bridle and Nasal patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient (18 years or older)
- received a nasoenteral feeding tube while being hospitalized
- providing written informed consent
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Gelre Hospitals
Apeldoorn
- Recruiting
Medisch Spectrum Twente
Enschede
Mariël Klos, +31(0)640973307, mariel.klos@MST.nl
About this study
Official title: 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).
- Conditions
- Feeding Tube Complication, Feeding Disorders
- Being tested
- Nasal bridle, Nasal patch
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal bridleDevice
Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA)
Nasal patchOther
Regular adhesive tape for medical use.
| Study group | Role | What they receive |
|---|---|---|
| Nasal bridle | Experimental | Nasal bridle fixation after nasoenteral feeding tube placement. Receives: Device: Nasal bridle |
| Nasal patch | Active comparator | Nasal patch fixation after nasoenteral feeding tube placement. Receives: Other: Nasal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature dislocation of feeding tube
Occurrence of a first premature dislocation of the feeding tube
Measured: Within 14 days after initial placement of the feeding tube
Secondary outcomes (3)
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
Measured: During the 14-day period after initial placement of the feeding tube
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
Measured: During the 14-day period after initial placement of the feeding tube
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
Measured: During the 14-day period after initial placement of the feeding tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding Tube ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelre Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Medisch Spectrum Twente
- Responsible party
- Sponsor
- Investigators
- Mariël Klos, Principal investigator, Gelre Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694299
- Sponsor's protocol ID
- 2021_67
- Other IDs
- 210808 (FIXIT)
- Acronym
- FIXIT
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD sharing plan has not been finished yet, scheduled for Q4 2023.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05694299
- Acronym / sponsor ID
- FIXIT / 2021_67
- Conditions
- Feeding Tube Complication, Feeding Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gelre HospitalsUniversity, hospital or other
- Collaborators
- Medisch Spectrum Twente
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal bridle | Experimental | Device: Nasal bridleNasal bridle fixation after nasoenteral feeding tube placement. |
| Nasal patch | Active comparator | Other: Nasal patchNasal patch fixation after nasoenteral feeding tube placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patient (18 years or older)
- received a nasoenteral feeding tube while being hospitalized
- providing written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal bridleBridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA) | Device | Nasal bridle |
| Nasal patchRegular adhesive tape for medical use. | Other | Nasal patch |
Primary outcome
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
3 secondary outcomes
Complications related to fixation of the feeding tube
Time frame: 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
Discomfort experienced from the nasal fixation
Time frame: During the 14-day period after initial placement of the feeding tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Yes. The IPD sharing plan has not been finished yet, scheduled for Q4 2023.
Related trials for Feeding Tube Complication
Not yet recruitingObservational study
The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes
Poor Oral Intake, Percutaneous Endoscopic Gastrostomy
Not yet recruitingObservational study
Albert Health App PEG Study
Feeding Tube Complication
Recruiting
PUSH-IT Continuing Enteral Feeds for Tracheostomy
Tracheostomy Complication, Critical Illness
Active, not recruiting
Cost-Effectiveness and Clinical Outcomes of Double J Stent Versus Percutaneous Feeding Tube Placement Following Open Pyeloplasty in Pediatric Patients: A Prospective Randomized Single-center Study
Pyeloplasty, Complications of Surgical Procedures or Medical Care
RecruitingObservational study
How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant
Preterm Birth, Feeding Methods
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariël Klos principal investigator
Gelre Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal bridle and Nasal patch in people with Feeding Tube Complication and Feeding Disorders, run by Gelre Hospitals at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tjard Schermer, PhD (+31(0)655102377, t.schermer@gelre.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature dislocation of feeding tube (time frame: Within 14 days after initial placement of the feeding tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.