Pressure Injury Prevention
Conditions
Keywords
Pressure injury, Intensive care unit, Endotracheal tube, Prevention
Brief summary
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.
Detailed description
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.
Interventions
OTHERUse of silicone foam dressing and repositioning every 8 hours
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, AQUACEL™ Foam, a sterile, waterproof dressing consisting of a polyurethane outer film layer and a multilayer absorbent pad with silicone adhesive borders, will be used.
OTHERRepositioning every 8 hours
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.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Patients admitted to the General Intensive Care Unit and receiving mechanical ventilation support * Absence of pressure injuries, other lesions, or anomalies on the inner and outer surfaces of the lips and at the oral commissures prior to intubation * Absence of congenital anomalies that could interfere with the assessment of pressure injuries on the inner and outer surfaces of the lips and at the oral commissures
Exclusion criteria
* Receiving mechanical ventilation support initiated prior to admission to the intensive care unit * Undergoing nasotracheal intubation * History of any intraoral surgical procedure * Presence of a contraindication to repositioning of the endotracheal tube * More than one hour having elapsed since intubation (for Group 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of whether a ETT related oral mucosa pressure injury develop | From intubation until the end of follow-up, up to 14 days. | Endotracheal Tube-Related Pressure Injury Assessment Form |
Contacts
CONTACTCansu CAMBAZ
Outcome results
None listed