An interventional study of High concentration Oxygen therapy and Control: Room Air or Low concentration Oxygen in Chronic Subdural Hematoma, Recurrence and Oxycephaly, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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).
Research Questions
Hypothesis Oxygen therapy for CSDH patients with post-operative pneumocephalus will experience significant resorption of intracranial air within 24 hours. There is a reduction in recurrence rate in terms of the re-operation rates. There is an improvement in functional outcome in terms of mRS.
Aim of the Study To evaluate changes in pneumocephalus volume and functional outcome after oxygen therapy in post-operative CSDH patients treated by burr hole drainage, as compared to the standard care by breathing in room air or low concentration oxygen during the post-operative period.
Study Design Prospective randomized 1:1 parallel-arm study
Methods and Randomization Patients will be recruited when they are considered fit for oxygen therapy as determined by the treating clinician. The timing of burr hole evacuation may vary according to the availability of the emergency operative time slot. The index intervention is postoperative oxygen therapy: 100% normobaric oxygen through a nonrebreather mask (NRM) at 12-15 Litre/minute consecutively for 24 hours. Removal of the nonrebreather mask is allowed during meals or other activities such as physiotherapy. The duration of mask removal would be documented. Compliance with NRM is considered to be good if the mask is kept > 90% of the time during the 24 hours treatment period. The reference intervention is standard post-operative care: the patient would be breathing in normobaric room air. For the reference arm, if the patient has desaturation (i.e. SaO2 \< 93%), supplemental O2 therapy can be given to keep SaO2 > 93%. Arterial blood gas would be obtained by the clinicians when deemed necessary. If there is a significant deviation from the study protocol occurs, the patients will be analyzed according to their originally assigned groups (intention-to-treat principle).
Non-rebreather masks, when they are tightly applied, are associated with a lower aerosol dispersion distance (as compared to non-invasive positive pressure ventilation or venturi masks).
Interim data analysis would be performed and the study would be terminated if a significant difference in the primary outcome is observed.
99 studies on the registry are indexed under Hematoma, Subdural; 29 are open to participants now.
This study's planned enrollment of 36 is below the median of 100 across 73 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours.
Procedure: High concentration Oxygen therapy
Room air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours.
Procedure: Control: Room Air or Low concentration Oxygen
FiO2 \>80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)
FiO2 \<30% Oxygen (Delivered with 0-2L/min Nasal Cannula)
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy
Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head
Time frame: 24 hours
Modified Rankins Scale (mRS)
Functional outcomes
Time frame: at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.
EuroQOL EQ-5D
Functional outcomes
Time frame: at 1 month, at 3 months and at 6 months.
Glasgow Coma Scale (GCS)
Neurological examination
Time frame: On admission, at 1 month, at 3 months and at 6 months.
Recurrence rate, as defined by reoperation rate due to symptomatic recurrence
Surgical complications
Time frame: 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
Volumetric measurement from Computed Tomographic (CT) scan for the Head
Time frame: after 24 hours of oxygen therapy and 1 week after oxygen therapy
Changes in volume of subdural fluid
Volumetric measurement from Computed Tomographic (CT) scan for the Head
Time frame: 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
Surgical complications
Time frame: Any surgically associated would infections within 6 months from the index operation
Incidence of deep wound infection, including subdural empyema
Surgical complications
Time frame: Any surgically associated would infections within 6 months from the index operation
Incidence of chest complications, including chest infection
Complications
Time frame: Any complications within the same admission episode for the index operation
Any complications arising from the Oxygen therapy (Adverse events)
Complications
Time frame: Any complications within the same admission episode for the index operation
Barthel Index
Functional outcome
Time frame: at 1 month, 3 months and 6 months
PaO2 and PaCO2 from the arterial blood gas (ABG)
Blood taking for ABG when judged to be necessary by the treating physician or when there is desaturation to SaO2 \< 93%
Time frame: During oxygen therapy
Duration of stay at the acute neurosurgical ward (LOS)
LOS
Time frame: During the same admission episode for the index operation
Discharge destination
Outcome
Time frame: Upon the same admission episode for the index operation
The length of stay in secondary care
LOS
Time frame: 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.
Death rate
Time frame: at 30 days, 3 months and 6 months.
Recurrence rate in BILATERAL Chronic Subdural Hematoma (CSDH)
Bilateral (CSDH)
Time frame: Within six months from the index operation
Volumetric reduction in pneumocephalus in BILATERAL Chronic Subdural Hematoma (CSDH) after Oxygen therapy
Bilateral (CSDH)
Time frame: Within 24 hours after Oxygen therapy
Improvement in mRS for BILATERAL Chronic Subdural Hematoma (CSDH)
Functional outcome in bilateral CSDH
Time frame: at 1 month, 3 months and 6 months
Plan to share: No
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Chinese University of Hong Kong