跳至主要内容
临床试验/NCT03762889
NCT03762889撤回不适用

Peri-operative Application of EYEPROTX General Anesthesia Protective Goggles as an Effective Modality to Reduce the Incidence of Corneal Injury Post-Intubation.

University of Miami1 个研究点 分布在 1 个国家开始时间: 2019年6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
撤回
试验地点
1
主要终点
Changes in Baseline Ocular Condition post-operatively

研究概览

简要总结

This is a randomized controlled trial that seeks to examine the effectiveness of Eyeprotx™ protective goggles in comparison to traditional methods against ocular injury that can occur perioperatively under general anesthesia.

详细描述

Ocular injury is but a devastating condition that can occur perioperatively under general anesthesia. Corneal abrasion is the most common ocular injury during general anesthesia, surpassing case incidence of damage caused by patient movement in ophthalmologic surgery. Causes of ocular injury include corneal drying due to the suppression of tear ducts from anesthetic agents, direct physical trauma, or agitation from the volatile anesthetic used. Ocular injury may also occur due to bacterial infection with MRSA, preventative methods, or rubbing of the eyes postoperatively due to agitation. Agitation may be caused by corneal drying or by shift or disruption in rapid eye movement sleep cycle from light penetration through the eyelids. Attempts at prevention of corneal abrasion have been used, including taping the eyelids shut, manual eye closure, paraffin-based ointment application into the conjunctival sac, and the use of hydrophilic contact lenses, although only a few studies have validated the comparison of these methods' effectiveness.

Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. Current ocular protective measures such as tapes during anesthesia have been associated with injury and infection. With this study, we hope to find a safer preventative technique against ocular injury during the perioperative period.

研究设计

研究类型
Interventional
分配方式
Non 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
是

入选标准

  • •Patients undergoing general anesthesia
  • •Patients admitted to Jackson Memorial Hospital

排除标准

  • •Patients unable to communicate, for whatever reason
  • •Patients predisposed to eye conditions
  • •Patients with history of increased intraocular pressure
  • •Patients with a medical history of Sicca syndrome
  • •Patients with claustrophobia
  • •Patients with pseudoexfoliation syndromes
  • •Patients with a current exopthalmic condition

研究组 & 干预措施

Eyeprotx™ Group

Experimental

This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.

干预措施: Eyeprotx™ General Anesthesia Protective Goggles (Device)

Eyelid Tape Group

Active Comparator

This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.

干预措施: Eyelid Tape (Device)

Eye Ointment Group

Active Comparator

This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.

干预措施: Eye Ointment (Device)

结局指标

主要结局

Changes in Baseline Ocular Condition post-operatively

时间窗: The patient's initial rating will be recorded approximately ten minutes before surgery at the point of anesthesia evaluation and will be reassessed up to 24 hours post-operatively.

The following will be measured upon evaluation, using a numerical scale of 1 to 8, with 1 being complete absence of condition and 8 being the most severe presentation of the condition: 1\. eye discomfort, 2, pain, and 3. dryness intensity, each on a numerical rating-scale of 1 to 8, The measures will be compared among the goggle, ointment, and tape groups.

Incidence of Ocular Complications post-operation

时间窗: Evaluation of these complications will be done from the point the patient has returned to the recovery room to up to one week post-surgery or until discharge, whichever comes first.

Incidence of corneal abrasion, conjunctivitis, MRSA infection, and direct ocular trauma will be assessed by the anesthesiologist or nurse anesthetist and will be recorded upon diagnosis of condition for all groups.

次要结局

  • Patient Awareness during Anesthesia(This measure will be evaluated up to 48 hours post-surgical operation.)
  • Incidence of Nightmare during Use(This measure will be evaluated up to 48 hours post-surgical operation.)

研究者

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

Leo Kleyman

Research Fellow

University of Miami

研究点 (1)

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