Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
研究概览
简要总结
60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.
This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patient
- •hospitalized in an intensive care unit
- •tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h
排除标准
- •Patient currently treated by eyedrops for glaucoma
- •antecedent of corneal transplant
- •ocular prosthesis
研究组 & 干预措施
Aqueous gel
In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator)
干预措施: Aqueous Gel (Device)
Aqueous gel
In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator)
干预措施: Artificial Tears (Device)
Eyelid occlusion dressing
In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator)
干预措施: Eyelid Occlusion Dressing (Device)
Eyelid occlusion dressing
In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator)
干预措施: Artificial Tears (Device)
结局指标
主要结局
Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
时间窗: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week
次要结局
未报告次要终点