Effect of PEEP on Intraoperative Hypothermia
Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study
研究概览
详细说明
It is well known that intraoperative hypothermia is associated with postoperative adverse clinical outcomes in various study populations. Intraoperative hypothermia has various adverse effects including impaired drug clearance, cold diuresis and hypovolemia, immunosuppression with increased infection risk, electrolyte disorders, coagulopathy with impaired platelet function, negative nitrogen balance, shivering, insulin resistance, and myocardial events. Numerous methods have been introduced to prevent intraoperative hypothermia, such as warming of infusion fluid, forced-air warming, heat-pads, heated water mattress, and heated humidifiers. However, in patients undergoing lumbar spine surgery in the prone position, these methods to prevent intraoperative hypothermia may partially effective because these methods, in clinical practice, have a significant limitation in their application.
Positive end-expiratory pressure (PEEP) reduces the venous return by increasing intrathoracic pressure. This causes carotid unloading, which leads to a secondary peripheral vasoconstriction by increasing thermoregulatory vasoconstriction threshold and blunts intraoperative hypothermia. Previous studies demonstrated that intraoperative PEEP significantly attenuated the extent of intraoperative hypothermia in patients undergoing tympanoplasty. However, the beneficial effect of PEEP on thermoregulation is not investigated in patients with the prone position for spinal surgery.
The investigators hypothesized that PEEP can reduce the extent of intraoperative hypothermia via thermoregulatory modulation. In this study, the investigators investigated the effect of PEEP on intraoperative core body temperature and the incidence of intraoperative hypothermia in patients undergoing spinal surgery
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、110-799
- Seoul National University of Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who were scheduled for elective spine surgery requiring more than 3 hours
Exclusion Criteria:
- Patients who do not agree to the study
- Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more
- Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension
- Patients with morbid obesity (BMI >35 kg/m2)
- Patients with clinically severe pulmonary disease
- Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded.
- Patients with taking non-steroidal anti-inflammatory drug within two weeks
- Patients with preoperative fever or hypothermia
- Patients with intraoperative intentional hypothermia for neuroprotection
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Group P
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
|
application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation
其他名称:
|
|
无干预:Group C
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively
|
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 |
|---|---|---|
|
Body temperature as assessed by esophageal temperature probe
大体时间:180 minutes after the completion of anesthesia induction
|
Body temperature is assessed by esophageal temperature probe.
The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome
|
180 minutes after the completion of anesthesia induction
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Thermoregulatory vasoconstriction threshold
大体时间:until 180 minutes after the completion of anesthesia induction
|
The time of the difference in skin temperature between forearm and fingertip becoming zero.
|
until 180 minutes after the completion of anesthesia induction
|
合作者和调查者
出版物和有用的链接
一般刊物
- Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013.
- Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. doi: 10.1152/ajpregu.2000.279.4.R1430.
- Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.