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临床试验/NCT05203016
NCT05203016已完成不适用

Complications Associated With Intraoperative Hypothermia in Obstetrics and Plastic and Maxillofacial Surgery. Unicentric Cohort Study.

Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2019年1月1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
402
试验地点
1
主要终点
Hypothermia

研究概览

简要总结

Maintaining intraoperative normothermia and temperature measurement is a marker of quality of care. We know that intraoperative hypothermia is associated with an increased risk of cardiovascular events, infection of the surgical wound, a longer hospital stay, discomfort, hemorrhage and transfusion demand.

Goals:

To know the incidence of perioperative hypothermia in routine clinical practice in different surgical settings in a national reference university hospital.

To establish if hypothermia is a risk factor for developing postoperative complications, focusing mainly on bleeding and infection of the surgical wound, in subjects aged between 18-65 years who come to the La Paz University Hospital for a surgical intervention in the Obstetrics / Plastic and Maxillofacial Surgery Services.

Hospital-based cohort study. A two-year follow-up of patients between 18 and 65 years will be carried out. Those patients with haemostasis disorders and infections in the preoperative period will be excluded.

Using a questionnaire on sociodemographic variables, the baseline conditions of the patients will be evaluated for inclusion in the study. Subsequently, the temperature will be measured at the beginning and at the end of the surgery, as well as during admission to the Post Anesthesia Care Unit, where the temperature normalization time will be noted in the event of hypothermia. In retrospect, those variables corresponding to the late postoperative period will be evaluated and the telephone interview will be conducted to assess the quality of care received. All the data will be reflected in the collection booklet that we present in the annex.

Patient demographics, case characteristics, and temperature records were summarized using descriptive statistics.

Microsoft Excel (Professional Plus 2010, version 14); it was used for data management and processing, with Stata (version 14; StataCorp LP, College Station, TX) for graphical representations and statistical tests. A multivariate analysis of potential confounding factors will be performed.

These results will serve to know the incidence of hypothermia according to the usual practice in a Spanish tertiary hospital and to establish recommendations in the management of intraoperative hypothermia and its prevention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 65 years, of any ethnic origin, with any type of comorbidities, with surgical indication in the Plastic, Maxillofacial and Obstetrics Surgery services scheduled or emergency under any mode of anesthesia (spinal, epidural, spinal combined or general anesthesia), following the usual practice of the service.
  • That you agree to participate in the study by signing the informed consent.

排除标准

  • Children under 18 or over 65 years of age, having received active prewarming in the preoperative period, received anti-fibrinolytic treatment, with bleeding diathesis, untreated perioperative anemia, preoperative perinatal infections and / or requiring intraoperative blood transfusion.
  • Patients who for any reason should not be included in the study according to the evaluation of the research team and / or who refuse to participate in the study.

结局指标

主要结局

Hypothermia

时间窗: Through study completion, an average of 1 year.

Body core temperature below 36ºC

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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