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临床试验/NCT05702320
NCT05702320招募中不适用

Investigation of the Effect of Reflective Blanket on Reducing the Development of Undesirable Perioperative Hypothermia

Öğr. Gör. Ali GÜZEL1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
102
试验地点
1
主要终点
Does the application of passive insulation with a reflective blanket during the perioperative process reduce the incidence of unwanted Perioperative Hypothermia in patients?

研究概览

简要总结

The aim of this study is to determine the effect of using reflective blankets, which is a passive insulation product, on preventing UPH in patients scheduled for abdominal surgery under general anesthesia. It will also be evaluated whether the reflective blanket has an effect on the patients' thermal comfort and shivering levels. Inconsistent results have been reported in studies using reflective blankets. This inconsistency may be due to the fact that it was used at different stages of the perioperative process or that the body was not adequately isolated. In this study, we aimed to use the reflective blanket throughout the perioperative process and to isolate the patient's body as much as possible. Reflective blankets are inexpensive, practical to use and easy to store. With the positive results that can be obtained from this study, it can be used not only in operating rooms, but also in intensive care or other services where hypothermia is likely to occur.

Within the scope of the study, a Reference group (warm air blower device), an Intervention group (reflective blanket) and a Control group (routine hospital procedure) will be established. The study was planned to be conducted with a total of 102 patients, with 34 patients in each group.

In this study; patients' vital signs, coagulation tests, thermal comfort and shivering levels will be evaluated. Patients in the Reference and Intervention group will be warmed before the surgery (15 minutes), during the surgery, and until they are transferred from the post-anaesthetic care unit to the clinic. No heating process will be applied to the control group by the researcher. All patients transferred to the clinic will undergo the routine care procedure of the hospital.

详细描述

Undesirable perioperative hypothermia (UPH) is a decrease in the core body temperature, expressed as the temperature of the blood and internal organs, below 36°C. UPH is an important complication of -anesthesia- and surgery and can occur during the period from the preoperative period (1 hour before anesthesia) to the postoperative period (the first 24 hours after anesthesia). There is a risk of developing UPH in all patients who will undergo surgery.

The application of general anesthesia, the cold environment of the operating room, the openness of the operated internal body region to ambient temperature, the long duration of the operation, the use of unheated IV fluids and irrigation fluids contribute to the development of UPH. Body temperature loss occurs rapidly with four mechanisms in the form of radiation, conduction, convection and evaporation before anesthesia and after anesthesia induction.

UPH causes many undesirable negative consequences for the patient. The deterioration of these patient comfort, flicker, myocardial problems, wound infection, wound healing problems, postoperative pain, platelet dysfunction, increased blood loss and blood transfusion requirements, renal function deterioration, a decrease in drug metabolism, anesthesia, post-operative care unit and prolong the length of stay in hospital and is expressed in the increase of mortality.

In the perioperative process, two methods are used to warm patients in the form of active and passive heating (insulation). Active heating, hot air blown systems, electric drapes (resistive systems), radiant heaters, intravenous fluids, blood, blood-product heaters, heat and moisture exchanger, filters, heating methods include negative pressure. While systems with hot air blowing reduce heat loss by radiation, they also provide temperature increase by convection. Heating devices should be used together with special suitable blankets and these blankets should cover as much of the body as possible. Cotton-wool blankets, socks, surgical drapes or plastic drapes with metal additives are used for passive heating. The effect of passive insulation is directly proportional to the area covered. Passive heating is recommended to prevent hypothermia in patients with a body temperature of 36 °C and above, and active heating is recommended in patients with a body temperature of less than 36°C.

It is stated that patients who are scheduled for general anesthesia should be warmed up for at least 10-20 minutes before surgery.The combination of more than one heating technique to ensure normothermia increases the effectiveness. Heating with hot air blowing devices is a widespread and effective approach to achieving normothermia and patient satisfaction. The superiority of these devices has been proven in many studies. On the other hand, providing a heating unit for each patient both in the operating room and in the post-anesthesia care unit will cause a serious cost increase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • abdominal surgery is planned,
  • ASA I-II patients,
  • who will undergo general anesthesia,
  • operations where the anesthesia time is expected to take 30-120 minutes
  • the age of 18,
  • with a body mass index of 18.5-35 kg/m2,
  • who can read and write,
  • who participate voluntarily.

排除标准

  • Patients who used any corticosteroids or other immunosuppressive drugs four weeks before surgery,
  • Patients with a recent history of fever and/or infection,
  • Patients with hypopituiterism,
  • Patients taking antipsychotics and antidepressants,
  • Patients with diabetic neuropathy,
  • Active otitis media patients

结局指标

主要结局

Does the application of passive insulation with a reflective blanket during the perioperative process reduce the incidence of unwanted Perioperative Hypothermia in patients?

时间窗: 12 months

Passive heating will be applied with a reflective blanket, body temperatures will be measured and the results will be recorded.

Does the application of passive insulation with a reflective blanket during the perioperative period increase the level of thermal comfort perception in patients?

时间窗: 12 months

Passive heating will be applied with a reflective cover, the thermal comfort levels of the patients will be measured with a thermal comfort perception assessment form and the results will be recorded.

Does the application of passive insulation with a reflective blanket during the perioperative process reduce the incidence of tremors in patients?

时间窗: 12 months

Passive heating will be applied with a reflective blanket, the tremor status of the patients will be measured with the tremor level assessment form and the results will be recorded.

次要结局

未报告次要终点

研究者

发起方
Öğr. Gör. Ali GÜZEL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Öğr. Gör. Ali GÜZEL

principal investigator

Bitlis Eren University

研究点 (1)

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