跳至主要内容
临床试验/NCT05389579
NCT05389579已完成不适用

Evaluation of Use of Woolen Blanket Together With Electric Blanket for Controlling Postoperative Hypothermia in Total Knee Arthroplasty Patients; Surgical Nursing Programme

Esra Demirarslan2 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
postoperative measures for 30th minute-3a

研究概览

简要总结

The purpose of this studywas to assess as experimental whether if electric blanket together withwoolen blanketwere effective in the postoperative period at patients with TKA. The population of the studywas the TKA patients operated at Kastamonu State Hospital (N=209); the sample with quota sampling was a total of 46 patients, including 23 selected 23 control group. Data collection forms for data collection, tympanic thermometer, saturation meter, sphygmomanometer, woolen blankets and electric blankets were used in research process.The data collected in this study were analyzed using SPSS 16.0 software. To analyze the data; descriptive statistics, Kolmogorov-Smirnov, X2, Student's t, Mann-Whitney U test, Kruskal-Wallis analysis of variance ANOVA and linear regression analysis were used. According to the results; it was determined that the use of electric blankets together with woolen blankets was an efficient method of warming for TKA patients and unheated woolen blanketsare not sufficient to improve body temperature postoperatively. Studying with large samples and assessing the effectiveness of warmed woolen blankets with determining the number of warmed woolen blanket for enhancing the control of hypothermia is suggested.

详细描述

Methods 2.1. Study Design and Setting As a parallel group, randomized controlled trial with repeated measures to test the following hypothesis: the average body temperature of patients who use an electric blanket along with a woolen blanket reaches a normal value at least one timeframe (15 minutes) before that of patients who use a woolen blanket. It was used electric blankets for the patients in the experimental group in addition to the routine practices in the clinic and did the routine practice in the clinic for the patients in the control group by the researcher.

The study was conducted in the orthopaedic clinic of a public hospital in Turkey with the capacity to serve 100.000 patients, where approximately 250 TKA operations are performed per year.

2.2. Sample Sample of the study included patients who had TKA under spinal and/or epidural anesthesia. Sample size calculation was performed using the Number Cruncher Statistical System (NCSS)-Power Analysis and Sample Size (PASS) software. Based on the differences in the mean scores of body temperatures for seven different times (before surgery, taking to their beds after surgery, 15th minutes, 30th minutes, 45th minutes, 60th minutes and 75th minutes after surgery) obtained from the patients in the pilot study, the alpha level was set at 0.05 and power as 80%. Thus, 23 patients were included in each group (23 patients in the experimental group and 23 patients in the control group). The patients were selected according to age and gender (each group: male: 4, female: 9 between 60- 69 ages; male: 3, female: 7 between 70-79 ages) and were randomized according to days of the week.

2.3. Participants and Procedure The inclusion criteria for this study were: being between the ages of 60 to 79, having an SPO2 value above 90% when they were hospitalized, no having diseases affecting cognitive functions or thermoregulation due to systemic effects, and no using any medication which could effect thermoregulation. Additionally, new patients were selected for the sample in place of patients who wished to withdraw from the study since they felt uncomfortable by the way the blanket was placed on them or were uncomfortable being uncovered above their wrists or ankles or lower than the bottom line of the clavicle, or who needed to remove the blanket completely because of the clinical interventions, or who had to be taken to the intensive care unit due to the unexpected changes in their general condition. Four different surgical teams and one single anesthesia team were performed the TKA surgeries in this hospital. The anesthesia team administered the same anesthetic medication as a spinal or local combined (spinal and epidural) to all patients in the sample.

The study was conducted between November 1, 2013, and May 1, 2014. The researcher (ED) informed the nurses in the clinic about the procedures to be done for the experimental and control groups. The day before the application of this study, the researcher reviewed the list of the operations to be performed the next day and identified patients who would have TKA. The researcher also evaluated the fitness of these patients to sample criteria and patients were informed both verbally and in written form. After obtaining informed consent, it was measured patients' height and weight, recorded their demographic data, family history, medical history and the taking medication on a descriptive characteristics information form (DCIF) by the researcher. The researcher measured the patients' body temperatures in the same ear in which their body temperatures were measured when they had been hospitalized. The researcher evaluated whether there were earpieces, infections or external auditory canals for plugs in deciding in which ear to measure the body temperature. To measure the pulse, arterial blood pressure and SPO2, it was used the arm that did not have established vascular access. It was obtained the temperature and humidity of the operating room one hour after each patient was taken to surgery and recorded this information on the DCIF.

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

入排标准

年龄范围
60 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being between the ages of 60 to 79,
  • having an SPO2 value above 90% when they were hospitalized,
  • not having diseases affecting cognitive functions or thermoregulation due to systemic effects,
  • not using any medication which could effect thermoregulation.

排除标准

  • patients who wished to withdraw from the study since they felt uncomfortable
  • because of the clinical interventions, or who had to be taken to the intensive care unit due to the unexpected changes in their general condition.

结局指标

主要结局

postoperative measures for 30th minute-3a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 75th minute-6a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 30th minute-3b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 30th minute-3d

时间窗: within 5 minutes

patients' saturation

preoperative measures-1b

时间窗: 15 minutes before surgery

patients' tympanic heart beat rate/min

postoperative measures for 15th minute-2b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 15th minute-2c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 45th minute-4d

时间窗: within 5 minutes

patients' saturation

preoperative measures-1c

时间窗: 15 minutes before surgery

patients' ventilation rate/min

preoperative measures-1e

时间窗: 15 minutes before surgery

patients' systolic/daistolic blood pressure mmHg

postoperative measures for 15th minute-2e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

preoperative measures-1a

时间窗: 15 minutes before surgery

patients' tympanic temperature °C

postoperative measures for 60th minute-5c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 60th minute-5d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 75th minute-6e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

postoperative measures for 105th minute-8b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 105th minute-8e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

preoperative measures-1d

时间窗: 15 minutes before surgery

patients' saturation SaO2

postoperative measures for 15th minute-2a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 15th minute-2d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 30th minute-3c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 45th minute-4b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 45th minute-4c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 45th minute-4e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

postoperative measures for 60th minute-5a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 60th minute-5e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

postoperative measures for 90th minute-7d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 90th minute-7e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

postoperative measures for 45th minute-4a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 75th minute-6d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 90th minute-7a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 90th minute-7b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 90th minute-7c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 30th minute-3e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

postoperative measures for 60th minute-5b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 75th minute-6b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 75th minute-6c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 105th minute-8a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 120th minute-9b

时间窗: within 5 minutes

patients' heart beat rate

postoperative measures for 120th minute-9d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 105th minute-8c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 105th minute-8d

时间窗: within 5 minutes

patients' saturation

postoperative measures for 120th minute-9a

时间窗: within 5 minutes

patients' tympanic temperature

postoperative measures for 120th minute-9c

时间窗: within 5 minutes

patients' ventilation rate

postoperative measures for 120th minute-9e

时间窗: within 5 minutes

patients' systolic/diastolic blood pressure

次要结局

  • end of measurement(within 125 minutes)

研究者

发起方
Esra Demirarslan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esra Demirarslan

Instructor

Kastamonu University

研究点 (2)

Loading locations...

相似试验