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临床试验/NCT02348242
NCT02348242已完成不适用

Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
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

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

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

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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