Role of Incentive Spirometry after Burr Hole Evacuation of Chronic Subdural Hematomas: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- The primary outcome is the recurrence rate following burr-hole evacuation.
研究概览
简要总结
Chronic subdural hematomas are a common clinical condition encountered in day-to-day neurosurgical practice. Management of chronic subdural hematomas may be either surgical or conservative. Burr hole drainage is currently the most common surgery used worldwide for the treatment of chronic subdural hematomas. However, recurrence after surgical evacuation is a common problem and has been found to occur in the range of (5-30)%. A number of factors are associated with post-operative recurrence following surgical evacuation such as male gender, elderly age group, bilateral hematoma etc. Several adjuvant therapies with surgery are investigated for preventing recurrence which includes corticosteroids, atorvastatin and middle meningeal artery embolization. 3 ball incentive spirometry has been used in our institution following subdural hematoma evacuation to prevent recurrence. The main mechanism driving this idea is to increase the intracranial pressure and promote brain expansion which ultimately results in drainage of blood products.
Hence, this study is conducted to analyze the effect of incentive spirometry in preventing recurrence following burr-hole evacuation of chronic subdural hematoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with CT scans suggestive of chronic subdural hematoma undergoing burr hole evacuation.
- •2.Patients with GCS more than 13.
排除标准
- •1.Patients with acute subdural hematoma.
- •2.Patients with chronic subdural hematoma and GCS less than equal to
- •3.Patients with contraindications for spirometry (e.g. recent MI, unstable angina, bullous emphysema) 4.Patients not willing to participate in the study.
结局指标
主要结局
The primary outcome is the recurrence rate following burr-hole evacuation.
时间窗: The follow-up CT brain will be at 1 and 3 months to detect any recurrence
次要结局
- The secondary outcome will be the resolution of chronic SDH following burr hole evacuation(The follow-up CT brain will be done at 1 and 3 months to check for resolution)
研究者
RAHUL SAIKIA
Institute of Neurosciences, Kolkata