NCT01737645终止不适用
A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
研究概览
简要总结
This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.
详细描述
Eye pressure will be measured at protocol specified intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing prolonged procedures (scheduled >3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
- •Morbidly obese subjects: BMI ≥ 35 kg/m2
- •Thin subjects: BMI ≤ 30 kg/m2
- •ASA (American Society of Anesthesiologists) physical status classification I, II, or III
排除标准
- •Known history of glaucoma
- •Note:if initial IOP is noted to be >21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
- •Recent use of IOP lowering topical ophthalmic agents
- •Allergy to latex or proparacaine hydrochloride ophthalmic solution
- •Patients with active corneal epithelial defects or history of recurrent corneal erosion
- •Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology)
- •History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
- •Any eye surgery within prior 1 month
- •Known pregnancy
- •Cognitive impairment
结局指标
主要结局
To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
时间窗: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.
次要结局
- To determine rate of rise of IOP during steep Trendelenburg positioning(The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.)
- To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.(The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.)
研究者
Roy Soto, MD
Principal Investigator
William Beaumont Hospitals
研究点 (1)
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