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The endotracheal tube is one of the medical devices most associated with pressure injuries related to medical devices. This study aims to evaluate the effectiveness of applying a silicone foam dressing over the endotracheal tube and repositioning the endotracheal tube in preventing endotracheal tube-related pressure injuries in patients receiving mechanical ventilation support.
This study will be conducted as a prospective, parallel, three-group (1:1:1), randomized comparative trial. Data will be collected using the following instruments: the "Patient Descriptive Information Form," the "Braden Pressure Injury Risk Assessment Scale" to assess the risk of pressure injury development, the "M-ROMPIS" for staging endotracheal tube-related pressure injuries, and the "Endotracheal Tube-Related Pressure Injury Assessment Form" for monitoring the development of endotracheal tube-related pressure injuries. Data analysis will use both parametric tests (Independent Samples t-test, ANOVA) or non-parametric tests (Mann-Whitney U test, Kruskal-Wallis H test) based on the data distribution for comparisons involving two groups or multiple groups. The Chi-square test will be used for categorical variables. Logistic Regression Analysis will be performed to determine the effects of pressure injury development time and continuous variables obtained during patient follow-up on the development or non-development of pressure injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Use of silicone foam dressing and repositioning every 8 hours |
|
| Group 2 | Active Comparator | Repositioning every 8 hours |
|
| Group 3 | No Intervention | Standard care (Control Group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of silicone foam dressing and repositioning every 8 hours | Other | Patients assigned to this group will receive a silicone foam dressing applied over the endotracheal tube, with repositioning performed every 8 hours. As the silicone foam wound dressing, AQUACELâ„¢ Foam, a sterile, waterproof dressing consisting of a polyurethane outer film layer and a multilayer absorbent pad with silicone adhesive borders, will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of whether a ETT related oral mucosa pressure injury develop | Endotracheal Tube-Related Pressure Injury Assessment Form | From intubation until the end of follow-up, up to 14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cansu CAMBAZ | Contact | +9 0312 305 15 80 | cansuyildizoglu65@gmail.com |
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| Repositioning every 8 hours | Other | In patients assigned to this group, the initial repositioning following intubation and the first assessment of the lips, oral cavity, and perioral skin and mucosa will be performed 8 hours after intubation. If the endotracheal tube (ETT) is positioned at the right or left corner of the mouth, it will be repositioned to the midline; if it is positioned at the midline, it will be repositioned to either the right or left corner of the mouth. Following the initial repositioning, subsequent repositioning procedures will be performed every 8 hours. |
|
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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