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| ID | Type | Description | Link |
|---|---|---|---|
| 210808 (FIXIT) | Other Identifier | Medical Ethics Committee Isala Zwolle The Netherlands |
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| Name | Class |
|---|---|
| Medisch Spectrum Twente | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal bridle | Experimental | Nasal bridle fixation after nasoenteral feeding tube placement. |
|
| Nasal patch | Active Comparator | Nasal patch fixation after nasoenteral feeding tube placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal bridle | Device | Bridle Pro® Nasal Tube Retaining System (Applied Medical Technology Inc., Brecksville, OH, USA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the 14-day period after initial placement of the feeding tube |
| Pain experienced from the nasal fixation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tjard Schermer, PhD | Contact | +31(0)655102377 | t.schermer@gelre.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mariël Klos | Gelre Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre Hospitals | Active, not recruiting | Apeldoorn | Netherlands | |||
| Medisch Spectrum Twente |
The IPD sharing plan has not been finished yet, scheduled for Q4 2023.
Data are expected to become available in the course of 2024.
Will be defined as part of the IPD sharing plan, scheduled for Q4 2023.
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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The data analist who will perform the statistical analyses (TS) will be masked (i.e., will analyze groups labelled as 'A' and 'B').
| Nasal patch | Other | Regular adhesive tape for medical use. |
|
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 | 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 |
| Recruiting |
| Enschede |
| Netherlands |
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