Status:
UNKNOWN
High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Chronic Subdural Hematoma
Recurrence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 l...
Detailed Description
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 drai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04725851
Start Date
July 26 2022
End Date
December 31 2024
Last Update
July 28 2022
Active Locations (1)
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1
Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong, 852