A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Proportion of Participants With Eyelid Erythema
研究概览
简要总结
This study compares TegadermTM and EyeGard® in general anesthesia.
详细描述
Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgeries scheduled for anesthesia of any duration
排除标准
- •Any patient that does not consent
- •Any patient who has:
- •Pre-existing eyelid erythema or other eyelid trauma
- •Eyelid piercings
- •Any surgery on the head, brain, neck, teeth, mouth, eyes or face
- •Surgery in the prone position
- •Patients <18 years old
研究组 & 干预措施
TegadermTM on R eye, EyeGard® on L eye
Patients will get TegadermTM on Right eye, EyeGard® on Left eye
干预措施: Medical tapes: TegadermTM and EyeGard® (Device)
TegadermTM on L eye, EyeGard® on R eye
Patients will get TegadermTM on Left eye, EyeGard® on Right eye
干预措施: Medical tapes: TegadermTM and EyeGard® (Device)
结局指标
主要结局
Proportion of Participants With Eyelid Erythema
时间窗: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema: 0- no erythema 1. mild erythema 2. moderate erythema 3. severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.
次要结局
- Patient Satisfaction(post-operation)
- Rate of Corneal Abrasions(post-operation)