High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma (NCT04725851) | Clinical Trial Compass
UnknownNot Applicable
High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma
Hong Kong36 participantsStarted 2022-07-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy