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临床试验/NCT06454877
NCT06454877尚未招募不适用

Effect of Normothermia Care Bundle on Inadvertent Perioperative Hypothermia, Surgical Site Infection and Bleeding in Knee Replacement Surgery

Istanbul Saglik Bilimleri University0 个研究点目标入组 120 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
vital signs observation form

研究概览

简要总结

Osteoarthritis is a disease characterized by disruption of the integrity of articular cartilage as a result of erosion of articular cartilage. Knee osteoarthritis causes muscle weakness, crepitation and deformities in the knee joint, limiting the individual's movement and causing loss of function. The most prominent feature is pain. Therefore, knee replacement surgery is performed in advanced cases where pharmacologic treatment is not effective. Many complications can be seen during the operation process and some of them may occur due to hypothermia. Studies have reported that warming during the operation prevents hypothermia and reduces complications. In this study, it was aimed to examine the effect of active and passive heating applied before, during and after surgery on hypothermia, surgical site infections and bleeding. The population of the study will consist of patients who underwent knee replacement surgery in the Orthopedics and Traumatology Clinic of Üsküdar State Hospital between April 2024 and April 2025. Data will be collected using the patient identification form, normothermia care package observation form, preoperative follow-up form, postoperative follow-up form and postoperative long-term follow-up form. A randomization list generated from a computer-based random numbers table will be used to determine which group of patients will be included in the study. Patients will be followed up in 3 periods: preoperative, intraoperative and postoperative periods. The postoperative period will be evaluated in five stages as day 1, day 2, day 3, day 10 and day 30. The purpose of the study and the intervention to be applied will be explained to all groups to be included in the study by the researcher and written and verbal consent will be obtained from the volunteers. The groups included in the study will be subjected to the heating protocol according to the normothermia care package. Group A will receive active heating with the heating method using a hot air blowing device. Group B will receive passive heating using a reflective blanket. Group C was planned as a control group to be heated by applying the routine heating procedure of the hospital without any intervention. Body temperature and vital signs will be checked preoperatively and warming will be performed 30 minutes before surgery, and warming will be started 15 minutes before anesthesia induction during surgery and body temperature and vital signs will be checked. After the operation and in the ward, warming will be performed until the body temperature reaches 37 C°. The data obtained will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

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

入选标准

  • 18 years or older Planned elective knee arthroplasty surgery Patients planned for neuraxial block anesthesia ASA (American Society of Anesthesiologists) class I-III

排除标准

  • Alcohol and drug addiction, Patients who cannot be contacted Preoperative body temperature <36 C° or ≥37.5 C°

结局指标

主要结局

vital signs observation form

时间窗: Before surgery, during surgery, first 24 hours after surgery and first 3 days after surgery

in this form body temperature value will be evaluated

次要结局

  • drain follow-up form(first 3 days after surgery)
  • bleeding follow-up form(first 3 days after surgery)
  • observation form assessing surgical site infection(To be evaluated on the 3rd day, 10th day and 30th day after surgery)

研究者

发起方
Istanbul Saglik Bilimleri University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsen Ozturk Genc

PhD Student

Istanbul Saglik Bilimleri University

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