跳至主要内容
临床试验/NCT04686214
NCT04686214已完成不适用

The Effect of the Alterations in Body Temperature to Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

Istanbul University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年2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
39
试验地点
2
主要终点
blood loss in the group of patients who are kept normothermic

研究概览

简要总结

In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents

排除标准

  • Patients with body weight <35kg, morbid obesity (BMI> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate

结局指标

主要结局

blood loss in the group of patients who are kept normothermic

时间窗: surgery time (approximately 2 hours)

to test that blood loss is reduced in the group of patients who are kept normothermic by applying aggressive multiple warming method compared to the patient group in which mild-moderate hypothermia was allowed by using a standard single heater in an operation that poses a high risk for bleeding and hypothermia, such as AIS deformity correction surgery.

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

Nur Canbolat

Principal Investigator

Istanbul University

研究点 (2)

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