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临床试验/NCT03364283
NCT03364283已完成不适用

The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region

Ohio State University0 个研究点目标入组 109 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
主要终点
Incidence of intraoperative air embolism

研究概览

简要总结

The main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical course in the postoperative period, and the patient satisfaction will be compared between the groups.

详细描述

This was a prospective observational study to assess the effects of patient positioning during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based on the surgical position: sitting and horizontal. Each group was further divided into subgroups based on the type and location of the lesion. To achieve the study goals, comparison of the 2 approaches in equivalent patient groups was performed, including comparable demographics, diagnoses, topographic location of the lesions, anesthetic approaches, and surgical experience.

The operating surgeons decided patient positioning based on clinical judgment. Type of anesthesia was defined by the anesthesiologist in charge of the patient however, it was maximally standardized for both sites. All the surgeries were performed by neurosurgeons with sufficient experience of sitting craniotomies.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 - 75 years old undergoing open posterior cranial fossa and pineal region surgery and diagnosed with space-occupying or vascular lesions willing consent to participate in the study.

排除标准

  • Significant cardio-vascular comorbid conditions (cardiac insufficiency, recent infarction, advanced arterial hypertension)
  • Advanced chronic respiratory comorbid conditions
  • Uncorrected hypovolemia, anemia, hypoalbuminemia
  • De-compensated acid base and electrolyte disorders
  • Anticoagulated patients and patients with coagulation disorders, deep venous thrombosis (history of deep vein thrombosis or clinically established)
  • Preoperative evidence of spinal or peripheral nerve dysfunction that may interfere with patient positioning.
  • Cervical myelopathy
  • Cervical spine disorders (atlanto-occipital arthritis, previous fractures etc.)

结局指标

主要结局

Incidence of intraoperative air embolism

时间窗: Time of surgery (From surgical wound incision time until wound closure)

Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels

次要结局

  • Degree of tumor removal(End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery)
  • Patient satisfaction(End of surgery (closure) - 3 months after surgery)
  • Neurological function(End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.)

研究者

申办方类型
Other
责任方
Sponsor

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