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临床试验/NCT00129077
NCT00129077已完成不适用

Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?

Ann & Robert H Lurie Children's Hospital of Chicago4 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2004年3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
207
试验地点
4
主要终点
Development of corneal abrasions

研究概览

简要总结

The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

详细描述

Critically ill children may require neuromuscular blockade as a treatment modality. These children require careful eye care to prevent corneal abrasions. However, current evidence does not exist to guide best practices on eye care. This research study will evaluate 2 types of eye care therapy. The eyes will be randomly assigned to the control or experimental eye care therapy group. The control eye will receive lubricating ointment every 6 hours. The experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. Using daily fluorescein staining to detect corneal abrasions, each child will be studied for up to 9 days. Children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. The two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Weeks 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age greater than 42 weeks post-conceptual age and less than 18 years
  • Anticipated need for neuromuscular blockade therapy for at least 24 hours

排除标准

  • Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study)
  • Past medical history of abnormal blink reflex or incomplete lid closure
  • History of daily eye drop use
  • Facial trauma
  • Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber
  • Known allergy to eye lubricant

结局指标

主要结局

Development of corneal abrasions

时间窗: 9 days

次要结局

  • Incidence of corneal abrasions(36 hours)

研究者

研究点 (4)

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