High Concentration of Inspired Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma: A Randomized Controlled Trial (HOPE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in the volume of pneumocephalus after 24 hours of oxygen therapy
研究概览
简要总结
Normobaric oxygen therapy was shown to be effective in reducing post craniotomy pneumocephalus. Theoretical assessment of normobaric oxygen therapy in treating pneumocephalus has shown that a higher level of oxygen concentration will significantly decrease the time for absorption of pneumocephalus. The therapeutic efficacy is not fully established in patients with chronic subdural hematoma after burr hole drainage. Both radiological outcomes and clinical outcomes would be evaluated.
详细描述
Chronic subdural hematoma (CSDH) is not a benign disease. Morbidity and mortalities were high especially in those with recurrence requiring reoperations. The use of subdural drain after burr hole drainage is an excellent example demonstrating that by reducing CSDH recurrence, a significant improvement in functional outcomes can be observed.
Pneumocephalus is very common after burr hole drainage for CSDH. The use of high-flow oxygen had been reported to be effective in small case series, showing effectiveness in clinical and radiological outcomes. However, no large, prospective, controlled trial has been conducted to establish the efficacy of oxygen therapy on functional outcomes for patients with pneumocephalus after burr hole drainage in CSDH.
Bilateral CSDH has a different prognosis and is associated with a poorer outcome.
In addition to treating pneumocephalus, the use of perioperative oxygen has been suggested to minimize tissue hypoxemia and infection. In a study published in the New England Journal of Medicine, the use of perioperative supplementary oxygen was shown to reduce surgical site infection.
Hyperoxia with oxygen therapy has shown to be safe with minimal changes to the cerebral blood flow (CBF) from functional magnetic resonance imaging (fMRI).
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
- 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
- 否
入选标准
- •Age greater than or equal to 18 years-old.
- •Presence of chronic subdural haematoma (CSDH) as diagnosed radiologically either by computed tomography (CT) brain scan or magnetic resonance imaging (MRI).
- •Treatment of CSDH by burr-hole evacuation.
- •Presence of post-operative pneumocephalus, as evidenced from post-operative CT Brain or MRI brain
- •Negative test to SARS-nCoV-2, as evidenced by either deep throat saliva rapid test, deep throat saliva PCR test, nasopharyngeal swab real-time PCR test, or nasopharyngeal swab rapid test within seven days.
排除标准
- •Presence of pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD) and hence not suitable for oxygen therapy.
- •Any pre-existing illness that renders the patient moderately or severely disabled before diagnosis with CSDH, such as a history of central nervous system infection.
- •CSDH arising from secondary causes, such as intracranial hypotension, thrombocytopenia, etc.
- •Any evidence or suspicion that there is communication between the pneumocephalus with the air cells (e.g. such as mastoid air cells) or air sinuses (e.g. frontal sinus).
- •Patients that need an additional procedure e.g. epidural blood patch, etc.
- •Complications arising from the burr-hole operation or subdural drain insertion such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect the patient's long-term functional outcome.
- •Patients already on long-term steroid for pre-existing medical conditions.
- •Participation in other clinical trials within four weeks upon recruitment.
- •Pregnancy or on breastfeeding.
- •Any other reasons that the researchers consider the patients to be unsuitable.
结局指标
主要结局
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy
时间窗: 24 hours
Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head
次要结局
- Glasgow Coma Scale (GCS)(On admission, at 1 month, at 3 months and at 6 months.)
- Modified Rankins Scale (mRS)(at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.)
- EuroQOL EQ-5D(at 1 month, at 3 months and at 6 months.)
- Recurrence rate, as defined by reoperation rate due to symptomatic recurrence(Reoperation rate within six months, including the number of re-operations for CSDH during the same admission episode, as well as subsequent readmission for reoperation for CSDH.)
- Changes in brain volume re-expansion(after 24 hours of oxygen therapy and 1 week after oxygen therapy)
- Changes in volume of subdural fluid(Recurrence or re-accumulation rate, as measured by an increase in subdural fluid volume at 1 week, 1 month, 3 months, and at 6 months.)
- Incidence of superficial wound infection(Any surgically associated would infections within 6 months from the index operation)
- Incidence of deep wound infection, including subdural empyema(Any surgically associated would infections within 6 months from the index operation)
- Incidence of chest complications, including chest infection(Any complications within the same admission episode for the index operation)
- Any complications arising from the Oxygen therapy (Adverse events)(Any complications within the same admission episode for the index operation)
- Barthel Index(at 1 month, 3 months and 6 months)
- PaO2 and PaCO2 from the arterial blood gas (ABG)(During oxygen therapy)
- Duration of stay at the acute neurosurgical ward (LOS)(During the same admission episode for the index operation)
- Discharge destination(Upon the same admission episode for the index operation)
- The length of stay in secondary care(Upon transferal to the secondary care from the same admission episode for the index operation)
- Mortality rate at 30 days, 3 months and 6 months.(at 30 days, 3 months and 6 months.)
研究者
Dr. David Yuen Chung CHAN
Clinical Assistant Professor
Chinese University of Hong Kong