Forced-Air Warming for Preventing Perioperative Hypot
Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study
Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA.
A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.
研究概览
详细说明
This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA).
A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period.
The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter.
The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection.
This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200233
- Shanghai 6th People's Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age between 60 and 85 years
- ASA physical status I or II
- Diagnosed with knee osteoarthritis
- Undergoing first unilateral primary total knee arthroplasty
- Able to provide written informed consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Forced-Air Warming Group
Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.
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Active perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit.
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有源比较器:Routine Warming Group
Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.
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Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Inadvertent Perioperative Hypothermia
大体时间:From anesthesia induction to 90 minutes after anesthesia completion
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The proportion of participants with core body temperature below 36.0°C at any perioperative time point.
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From anesthesia induction to 90 minutes after anesthesia completion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Shivering
大体时间:From the end of surgery to 24 hours postoperatively
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Incidence and severity of postoperative shivering assessed using a 0-4 shivering scale.
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From the end of surgery to 24 hours postoperatively
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Emergence Agitation
大体时间:From 30 minutes after surgery to 2 hours postoperatively
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Incidence and severity of emergence agitation assessed using the Richmond Agitation-Sedation Scale (RASS, -5 to +4), where higher positive scores indicate greater agitation.
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From 30 minutes after surgery to 2 hours postoperatively
|
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Anesthetic Recovery Time
大体时间:From the end of anesthesia to 2 hours postoperatively
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Recovery outcomes including awakening time, extubation time, and PACU length of stay.
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From the end of anesthesia to 2 hours postoperatively
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Intraoperative Blood Loss
大体时间:During surgery
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Estimated blood loss recorded during the surgical procedure.
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During surgery
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Postoperative Complications
大体时间:From the end of surgery to 30 days postoperatively
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Incidence of postoperative complications including delirium, nausea and vomiting, cardiac adverse events, skin burns, and surgical site infection.
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From the end of surgery to 30 days postoperatively
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合作者和调查者
调查人员
- 首席研究员:Danling Fang, RN、Shanghai 6th People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TKA-FAW-2018-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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