The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Ocular Dryness Score
研究概览
简要总结
The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Based on the findings, the study seeks to provide evidence-based contributions to nursing practices. Additionally, it aims to identify educational strategies to enhance intensive care nurses' knowledge and practice levels and to support the development of clinical care protocols.
H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients.
H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients.
H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 28 days to 18 years
- •Receiving invasive mechanical ventilation
- •Admitted to the pediatric intensive care unit
- •Parent(s) or legal guardian(s) provide informed consent for participation
排除标准
- •Having eye-related disease
研究组 & 干预措施
Artificial tears
Every 2 hours, artificial tear solution was gently applied to the designated eye. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation. The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.
干预措施: Eye Care with Artificial Tears (Other)
Saline
Every 2 hours, saline solution (Bio-Fleks brand) was gently applied to the assigned eye for saline group.The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.
干预措施: Eye Care with Normal Saline (Other)
结局指标
主要结局
Change in Ocular Dryness Score
时间窗: Everyday for 5 days after the inclusion of participant
Ocular dryness will be measured using the Schirmer test.The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
Occurence of Ocular Surface Disease
时间窗: 1 time Everyday for 5 days after the inclusion of participant
Florescein testing will be used to evaluate the development of ocular surface disease
Change in Eyelid Closure Degree
时间窗: 1 time everyday for 5 days after the inclusion of participant
Eyelid Closure Degree was evaluated by clinical observation and scoring (e.g., staining intensity and affected area). The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
次要结局
未报告次要终点
研究者
Senanur Şimşek
Principal Investigator
Marmara University