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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
124
No other intervention
University of Porto - Biomedical Sciences Institut
Porto, Portugal
Changes in tympanic temperature (T1)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: Baseline (entrance in the operating room)
Changes in tympanic temperature (T2)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: immediately after anesthesia
Changes in tympanic temperature (T3)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: 15 minutes after beginning surgery
Changes in tympanic temperature (T4)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: 30 minutes after beginning surgery
Changes in tympanic temperature (T5)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: 45 minutes after beginning surgery
Changes in tympanic temperature (T6)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Time frame: Up to 10 min after the end of surgery (living the operating room)
Changes in shivering (T1)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Time frame: Baseline (entrance in the operating room)
Changes in shivering (T2)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
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Time frame: immediately after anesthesia
Changes in shivering (T3)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Time frame: 15 minutes after beginning surgery
Changes in shivering (T4)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Time frame: 30 minutes after beginning surgery
Changes in shivering (T5)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Time frame: 45 minutes after beginning surgery
Changes in shivering (T6)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Time frame: Up to 10 min after the end of surgery (living the operating room)
Changes in visual perception of Thermal comfort (T1)
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.
Time frame: Baseline (entrance in the operating room)
Changes in visual perception of Thermal comfort (T2)
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.
Time frame: immediately after anesthesia
Changes in visual perception of Thermal comfort (T3)
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.
Time frame: 15 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T4)
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.
Time frame: 30 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T5)
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.
Time frame: 45 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T6)
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.
Time frame: Up to 10 min after the end of surgery (living the operating room)
General intraoperative comfort
Method of assessment - the Perioperative Comfort Scale, based on Kolcaba´s theory, composed of 15 items answered by a six-point Likert scale ranging from 1 (totally disagree) to 6 (I totally agree), which measures general aspects of comfort in three dimensions: relief, ease and transcendence.
Time frame: 30 minutes after beginning surgery
Thermal intraoperative comfort
Method of assessment - the Thermal Comfort Scale, composed of 9 items answered by a six-point Likert scale ranging from 1 (totally disagree) to 6 (I totally agree), which measures thermal aspects of comfort in two dimensions: physical and emotional.
Time frame: 30 minutes after beginning surgery
Ergonomic comfort
Method of assessment - the Ergonomic questionnaire, composed of 10 items answered by a five-point Likert scale ranging from 1 (not at all comfortable) to 5 (very comfortable).
Time frame: 30 minutes after beginning surgery