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临床试验/NCT04985617
NCT04985617已完成不适用

The Effects of Active Warming on Temperature on Core Body and Thermal Comfort in Patients After Transurethral Resection of The Prostate

Ege University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

HÜLYA YILMAZ, PhD

Principal Investigator, Msc, PhD Hülya YILMAZ

Ege University

研究点 (2)

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