The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries: A Randomized Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hacettepe University
- Enrollment
- 75
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Investigators
Cansu CAMBAZ
Research Assistant
Hacettepe University