The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Thermal Comfort Scale (TCS)
研究概览
简要总结
Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF) on the core body temperature and the patients' thermal comforts during the postoperative period in patients undergoing transurethral resection of the prostate (TURP).
Design: This was a prospective, randomized controlled experimental study. Methods: A total of 105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia care unit. The fluids in the experimental group were warmed until the body temperature was reached 36.0°C.
详细描述
Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF) on the core body temperature and the patients' thermal comforts during the postoperative period in patients undergoing transurethral resection of the prostate (TURP).
Design: This was a prospective, randomized controlled experimental study. Methods: A total of 105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia care unit. The fluids in the experimental group were warmed until the body temperature was reached 36.0°C. The intravenous (IV) fluid given to the two groups was 1000 ml of 0.9% isotonic sodium chloride solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The intervention and measurements were carried out by the first researcher, and the patients discovered their own groups when the postoperative warming intervention was applied to them. Because of the nature of the intervention, blinding could not be performed
入排标准
- 年龄范围
- 37 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients who age bigger than18,
- •patients who were undergoing general anesthesia, to whom voluntary hypothermia was not applied during the operation,
- •patients who were hemodynamically stable,
- •patients who had a physician's order for 1000 ml of 0.9% Isotonic Sodium Chloride IV fluid treatment,
- •patients were undergoing bladder irrigation were included in the study.
- •patients the sense, expression of heat by the patient in recovery,
- •patient who accepted to participate to the study
排除标准
- •patients have any infection, fever
- •patients have underlying diseases (hypothyroidism, hyperthyroidism, diabetes, cardiovascular disease or kidney failure)
- •patients who had mental deficiency that could prevent communication,
- •patients who had visual or hearing impairments,
- •patients who were receiving mechanical ventilation support, were sedated,
- •patients were the need for open surgery or any reason for returning the patient to the operating room,
- •patients need for postoperative blood transfusions,
- •patients have intra-abdominal infection,
- •patients have an unexpected allergy to anesthetic drugs,
- •patients have a temperature higher than 36.0ºC,
- •patients have for cardiopulmonary resuscitation,
- •patients have severe hemodynamic changes during the operation.
研究组 & 干预措施
Warmed Fluids
When patients recovered from the effect of anesthesia, awakened and were able to switch to normal spontaneous breathing, they were taken from the sober unit to the service or intensive care unit, and subsequent follow-ups were carried out by the researcher in these units. The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
干预措施: Warmed Fluids (Other)
Room Temperature Fluids
When patients recovered from the effect of anesthesia, awakened and were able to switch to normal spontaneous breathing, they were taken from the sober unit to the service or intensive care unit, and subsequent follow-ups were carried out by the researcher in these units. The IV fluid given to the patients in the control group was given at room temperature without heating and without intervention
结局指标
主要结局
Thermal Comfort Scale (TCS)
时间窗: 6 months
Thermal Comfort Scale (TCS): This is a Likert type scale which was developed by Wagner et. al. (2006) and the validity and reliability in Turkish was tested by Özsaban (2017). The evaluation of thermal comfort was made by the face to face interview method for all patients. The TCS evaluates the patient's temperature comfort perception subjectively. The scale consists of 13 items in total, and each item is scored between 1 and 6 points. A high score indicates a high temperature comfort level.
次要结局
未报告次要终点
研究者
HÜLYA YILMAZ, PhD
Principal Investigator, Msc, PhD Hülya YILMAZ
Ege University