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临床试验/NCT02293876
NCT02293876已完成不适用

Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial

Hospital Risoleta Tolentino Neves1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
1
主要终点
Keratitis

研究概览

简要总结

The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.

详细描述

Critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 93 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ramsay sedation scale 5 or 6
  • •Glasgow coma scale lower than 7
  • •Use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation
  • •Blink reflex less than 5 times per minute or ocular globe exposure

排除标准

  • •Less than 48 hours in Intensive Care Unit

研究组 & 干预措施

Eye drop

Sham Comparator

Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing.

干预措施: LACRIBELL® (Device)

Ocular gel

Sham Comparator

Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.

干预措施: LIPOSIC® (Device)

Glad wrap

Sham Comparator

Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.

干预措施: Glad wrap (Device)

Control group

No Intervention

Ocular cleansing three times a day.

结局指标

主要结局

Keratitis

时间窗: Five days

Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

次要结局

未报告次要终点

研究者

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

Andreza Werli Alvarenga

RN, MD, PhD

Hospital Risoleta Tolentino Neves

研究点 (1)

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