Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Changes in tympanic temperature (T4)
研究概览
简要总结
This study compares the effectiveness of a new layered thermal insulation system (SIT-3c) versus the traditional thermal body protection (warmed forced air system) for patients under total knee arthroplasty, during the intra-operative phase.
详细描述
Protecting patients from the cold in the operating room is a complex problem that has encouraged the search for better and more effective thermal protection systems. Some disadvantages have been observed in the daily use of the recommended thermal protection system (forced warm air).
This study intends to design and evaluate the effectiveness of a three-layer thermal insulation system, comparing its effect with the forced warm air system on temperature variation, shivering incidence and comfort perception, in patients undergoing total knee arthroplasty under neuro-axial anesthesia, during the intra-operative phase.
Participants are randomly assigned to the experimental group (EG) or control group (CG). The experimental group receives as a skin protection the three-layer thermal insulation system (SIT-3c) and the control group receives the usual recommended system (forced warm air).
Both systems are placed at the entrance to the operating room and held on patients during the entire intra-operative phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years, with the diagnosis of gonarthrosis, to undergo total elective knee arthroplasty, under neuroaxial anesthesia, who agreed to participate in the study.
排除标准
- •With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy
结局指标
主要结局
Changes in tympanic temperature (T4)
时间窗: 30 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in shivering (T2)
时间窗: immediately after anesthesia
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T3)
时间窗: 15 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in tympanic temperature (T1)
时间窗: Baseline (entrance in the operating room)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T6)
时间窗: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in shivering (T1)
时间窗: Baseline (entrance in the operating room)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T6)
时间窗: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in tympanic temperature (T2)
时间窗: immediately after anesthesia
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T3)
时间窗: 15 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T5)
时间窗: 45 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in visual perception of Thermal comfort (T3)
时间窗: 15 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T5)
时间窗: 45 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in shivering (T4)
时间窗: 30 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T5)
时间窗: 45 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in visual perception of Thermal comfort (T1)
时间窗: Baseline (entrance in the operating room)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T2)
时间窗: immediately after anesthesia
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T4)
时间窗: 30 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T6)
时间窗: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
次要结局
- General intraoperative comfort(30 minutes after beginning surgery)
- Thermal intraoperative comfort(30 minutes after beginning surgery)
- Ergonomic comfort(30 minutes after beginning surgery)