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临床试验/CTRI/2025/07/091088
CTRI/2025/07/091088已完成不适用

Effect of upper versus lower body forced air warming in preventing perioperative hypothermia in patients undergoing lumbar spine surgeries: An observational study

Sanidhya N Rai1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年7月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
To compare the effectiveness of upper-body versus lower-body forced air

研究概览

简要总结

Patients meeting the inclusion criteria will be selected, and informed consent will be obtained in the preoperative setting by the principal investigator. Baseline characteristics, including age, sex, BMI, ASA status, and will be recorded preoperatively. In the preoperative area, body temperature will be measured with a thermometer by the preoperative nurse, and also train the patients to use the thermal comfort scale. After transfer to the operating room, patients will be covered with a cotton blanket, and baseline vitals will be recorded. Following IV access, anaesthesia will be induced, and a nasopharyngeal probe will be inserted for core temperature monitoring. Standardized anaesthesia will be maintained with inhalational agents. After prone positioning, as per discretion of attending anesthesiologist either upper or lower body blanket is placed over the patient by the anaesthesia technician. In the upper warming group, the blanket will be placed above the T4 level, covering the back and both arms. In the lower warming group, the blanket will be positioned below the coccyx, covering both legs and the lower buttocks. Intraoperative warming will be provided via a forced-air warmer, with temperature readings recorded every 15 minutes by the PI. The warmer will be adjusted based on core temperature by the attending Anesthesiologist. If core temperature is less than 36.5 degree celsius then warming temperature is adjusted to 45 degree celsius, if core temperature is 36.5 to 37.5 degree celsius then warming temperature is adjusted to 40 degree celsius, and turned off if  greater than 37.5 degree celsius. At the end of surgery, the forced-air warmer will be removed and the patient will be placed in the supine position, the patient is fully covered with a cotton blanket. After reversal from anaesthesia, the nasopharyngeal probe and tracheal tube will be removed. The patient is transferred to the post-anaesthesia care unit (PACU). The thermometer will be used to monitor temperature every 10 minutes (up to 30 min) by the post anaesthesia care nurse. Patients will rate shivering intensity (0=no shivering,1= intermittent, low intensity ,2=moderate shivering,3=continuous intense shivering) and thermal comfort (0mm=coldest imaginable,50mm=pleasant,100mm=warmest imaginable) every 10 minutes following arrival in the post anaesthesia care unit (PACU). Before discharge, Patient will rate their satisfaction with perioperative temperature management on a 5-point Likert scale (0=very dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=very satisfied). Additional data on adverse effects, blood loss, transfusions, anaesthesia time, unwarmed period, and fluid volume will be observed and data is collected by the principal investigator.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 19 to 65 years American Society of Anesthesiologists physical status 1 and 2 ASA 1 A normal, healthy patient ASA 2 A patient with mild systemic disease.

排除标准

  • Body mass index greater than 35 kg per meter square Preoperative body temperature greater than 38 degree Celsius or smaller than 36 degrees Celsius Pregnant women.

结局指标

主要结局

To compare the effectiveness of upper-body versus lower-body forced air

时间窗: To compare the effectiveness of upper-body versus lower-body forced air | warming in preventing perioperative hypothermia in patients undergoing lumbar | spine surgery will be assessed at 30 minutes post-surgery

warming in preventing perioperative hypothermia in patients undergoing lumbar

时间窗: To compare the effectiveness of upper-body versus lower-body forced air | warming in preventing perioperative hypothermia in patients undergoing lumbar | spine surgery will be assessed at 30 minutes post-surgery

spine surgery.

时间窗: To compare the effectiveness of upper-body versus lower-body forced air | warming in preventing perioperative hypothermia in patients undergoing lumbar | spine surgery will be assessed at 30 minutes post-surgery

次要结局

  • To evaluate perioperative temperature changes, incidence of shivering and postoperative thermal comfort in the patients(To assess patient satisfaction with the method of forced air warming used during)

研究者

发起方
Sanidhya N Rai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanidhya N Rai

Yenepoya School Of Allied Health Sciences

研究点 (1)

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