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