Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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 1. Does post-operative high-flow oxygen improve pneumocephalus in terms of volume reduction in CSDH patients after burr-hole drainage? 2. Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (radiologically) if pneumocephalus volume is reduced after oxygen therapy? 3. Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (clinically), as defined by symptomatic recurrence requiring reoperation, if pneumocephalus volume is reduced after oxygen therapy? 4. Does post-operative high-flow oxygen improve CSDH patients' functional outcome in terms of modified Rankin Scale (mRS) at 3 months and 6 months? 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05143216
Study type Observational
Source Chinese University of Hong Kong
Contact David YC CHAN
Phone 852-35052211
Email david.yc.chan@cuhk.edu.hk
Status Recruiting
Phase
Start date May 6, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06347796 - Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study N/A
Recruiting NCT04065113 - Middle Meningeal Artery Embolization for Chronic Subdural Hematoma N/A
Recruiting NCT02938468 - Mgt of Chronic Subdural Hematoma Using Dexamethasone Phase 2/Phase 3
Completed NCT03307395 - Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma N/A
Terminated NCT04502745 - A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation N/A
Terminated NCT03353259 - Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery Phase 2/Phase 3
Recruiting NCT02568124 - Tranexamic Acid in Chronic Subdural Hematomas Phase 2/Phase 3
Completed NCT02282228 - Detecting Chronic Subdural Hematoma With Microwave Technology N/A
Active, not recruiting NCT04816591 - Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA N/A
Recruiting NCT06401772 - The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma N/A
Completed NCT06134206 - Burr Hole Ultrasound Study N/A
Recruiting NCT03666949 - General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma N/A
Recruiting NCT03280212 - Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma Phase 3
Completed NCT03447327 - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma N/A
Recruiting NCT05374681 - Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization N/A
Recruiting NCT05267184 - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma N/A
Not yet recruiting NCT05900557 - Neurologic Deficits and Recovery in Chronic Subdural Hematoma N/A
Completed NCT02757235 - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma N/A
Terminated NCT02111785 - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma Phase 2/Phase 3
Recruiting NCT05599217 - Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)