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临床试验/NCT03965169
NCT03965169Unknown不适用

Incidence and Risk Factors of Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 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
入组人数
299
试验地点
2
主要终点
Prevalence of pressure injury

研究概览

简要总结

Patients undergoing surgery under general anesthesia are susceptible to pressure-induced soft tissue damage because there is no change in posture over an extended period of time. In particular, when the patient is in a prone position, unlike the supine position, the bony protruding portion of the front side must support the weight, which is more vulnerable to pressure injury. Previous studies have shown that the incidence of pressure injury during surgery varied from 5% to 66% and was more likely to occur in patients with long operating times, prone position, obesity, and poor skin condition. These pressure injuries increase postoperative complications, length of stay, and medical costs. Therefore, the investigators analyze the incidence of pressure injury in prone position and re-examine the risk factors of pressure injury.

详细描述

All of the anesthetic and surgical procedures performed on the subject during the period from the time the subject enters the operating room to the time the subject go to the recovery room are the same as those for the existing spine surgery. Immediately after entering the operating room, immediately before going to the recovery room, and at postoperative day 1 and 2, the patient's systemic skin condition is assessed to determine whether pressure damage has occurred. The primary endpoint is the incidence of pressure injury in the subject compared with the incidence of pressure injury in previous studies. To identify the risk factors for the occurrence of pressure injury, the investigators will statistically analyze the data collected with the assumption that this is related.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients undergoing elective spine surgery in prone position under general anesthesia

排除标准

  • Pre-existence of pressure injury

研究组 & 干预措施

Patients undergoing prone spinal surgery

Experimental

Patients undergoing elective spinal surgery in prone position under general anesthesia, which is performed by neurosurgeons in Seoul National University Hospital

干预措施: Prone spinal surgery (Procedure)

结局指标

主要结局

Prevalence of pressure injury

时间窗: From end of surgery to postoperative day 2

The pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The prevalence of pressure injury will be calculated by dividing the number of patients with pressure injury by the total number of patients.

次要结局

  • Site of pressure injury(From end of surgery to postoperative day 2)
  • Grade of pressure injury(From end of surgery to postoperative day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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