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临床试验/NCT05874453
NCT05874453Unknown不适用

Effect of Evidence-Based Eye Care Protocol in Intensive Care Units

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Corneal Changes Rating Scale

研究概览

简要总结

In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired.

If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. This study was planned as a randomized controlled experimental study to examine the effect of using an evidence-based protocol on eye care on ophthalmologic complications. Patients who meet the inclusion criteria will be randomized, and one eye of the patients will be assigned to the intervention group (experimental group) and the other to the control group. When the study reaches 40 patients, G*Power analysis will be applied and the sample size will be decided according to the result.

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
否

入选标准

  • •Patients connected to mechanical ventilator,
  • •Newly intubated patients,
  • •Patients who have not been diagnosed with keratopathy and keratoconjunctivitis as of hospitalization,
  • •Patients who have not been diagnosed with burns and facial injuries,
  • •Patients without chronic lagophthalmos and eye trauma before ICU admission

排除标准

  • •Patients who have received topical drug therapy other than ocular lubrication
  • •Patients with muscle weakness as a result of cranial nerve VII (facial) nerve palsy
  • •Patients with chronic lagophthalmos and eye infections
  • •Those with rheumatological diseases
  • •Those with neurological/neuropathic disease that will affect eye closure

研究组 & 干预措施

Intervention Group

Experimental

Eye care protocol to be appliedevaluation.

干预措施: eye care protocol (Other)

Control Group

No Intervention

Routine intensive care Eye care protocol to be applied

结局指标

主要结局

Corneal Changes Rating Scale

时间窗: 10th day of application

It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.

Corneal Changes Rating Scale

时间窗: the day before the intervention

It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.

Corneal Changes Rating Scale

时间窗: 5th day of application

It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.

次要结局

  • Dry Eye Rating Scale(10th day of application)
  • Dry Eye Rating Scale(the day before the intervention)
  • Dry Eye Rating Scale(5th day of application)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Ceyhan

Assoc.Prof

TC Erciyes University

研究点 (1)

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