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临床试验/NCT02722928
NCT02722928终止不适用

Impact of Intraoperative Ventilation With High Oxygen Content to Reduce the Incidence and Extent of Postoperative Pneumocephalus in Patients Undergoing Craniotomies

Ohio State University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
2
主要终点
Occurrence of Postoperative Pneumocephalus

研究概览

简要总结

The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.

详细描述

Background: Postoperative pneumocephalus is a common complication in patients undergoing craniotomies. Even though the treatment of postoperative pneumocephalus with the use of supplemental oxygen is well documented, yet not reports have shown its role for the prevention of this condition. We suggest the use of intraoperative ventilation with 100% oxygen as prophylaxis for the incidence and severity of postoperative pneumocephalus in patients undergoing intracranial surgery.

Objectives: The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.

Study Methods: A single-blinded, prospective study, randomizing 80 patients per group, expecting 80% power to detect a 20% decrease in pneumocephalus volume for the interventional group. Inclusion criteria: Patients >18 years, scheduled to undergo elective craniotomy, and be willing to give written informed consent.

Study Procedures: Once the tumor resection is completed and hemostasis started (beginning of stage 2), patients will be assigned to receive either 1:1 oxygen/air gas mixture (control group) or 100% oxygen (intervention group) until the end of the surgery. All patients will receive postoperative supplemental oxygen via nasal cannula. CT scan will be performed within 1 to 6 postoperative hours as standard of care. A blinded radiologist will review all CT scans and assess the extent and frequency of postoperative pneumocephalus.

Clinical Outcomes: Patients' demographic data, length of stage 2, period of time between the end of surgery and CT scan, and pneumocephalus volumetric measurements will be compared between groups. Baseline neurological status will be compared with clinical and imaging postoperative findings.

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
Single (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

  • Patients > 18 years of both sexes undergoing surgical procedures to treat hemispheric or posterior cranial fossa tumors and consenting to the study

排除标准

  • History of severe cardio-pulmonary disease.
  • Bleeding disorders
  • Previous neurosurgeries requiring cranial reconstruction
  • Head trauma
  • Decreased consciousness related to cerebral edema

研究组 & 干预措施

Conventional 1:1 oxygen/air gas mixture

No Intervention

80 patients will receive ventilation during the surgery with a 1:1 oxygen / air gas mixture

Pure oxygen ventilation

Experimental

Patients will receive controlled ventilation with a conventional 1:1 oxygen / air gas mixture (60% oxygen concentration) during the approach and tumor removal phases. Once tumor resection is completed and hemostasis started, this group of patients will be switched to ventilation with 100% (pure) oxygen concentration

干预措施: Controlled Ventilation with 100% oxygen (Other)

结局指标

主要结局

Occurrence of Postoperative Pneumocephalus

时间窗: One to six hours after surgery

Compare the occurrence rate of postoperative pneumocephalus (present or not present) in patients receiving intraoperative ventilation with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture

Volume of Postoperative Pneumocephalus

时间窗: One to six hours after surgery

Compare the extent (cm3) of postoperative pneumocephalus in patients ventilated intraoperatively with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture

次要结局

  • Pneumocephalus Volume and Anterior Fossa Surgery(One to six hours after surgery)
  • Pneumocephalus Volume and Posterior Fossa Surgery(one to six hours after surgery)
  • Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation(preoperative to postoperative day 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gurneet Sandhu

M.D.

Ohio State University

研究点 (2)

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