Chronic Subdural HematomaHOPENCT04725851
High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma
A study testing High concentration Oxygen therapy in people with Chronic Subdural Hematoma and Recurrence, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Recurrence, Oxycephaly
- What is being tested?
- High concentration Oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jul 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, 852
David YC Chan, MBBS, FRCS, 35052542 ext. 2542, david.yc.chan@cuhk.edu.hk
Wai Poon, MBChB, FRCS, 35051316, wpoon@surgery.cuhk.edu.hk
About this study
Official title: High Concentration of Inspired Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma: A Randomized Controlled Trial (HOPE Study)
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.
Read the 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 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
- Does post-operative high-flow oxygen improve pneumocephalus in terms of volume reduction in CSDH patients after burr-hole drainage?
- Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (radiologically) if pneumocephalus volume is reduced after oxygen therapy?
- 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?
- 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.
- Conditions
- Chronic Subdural Hematoma, Recurrence, Oxycephaly
- Being tested
- High concentration Oxygen therapy, Control: Room Air or Low concentration Oxygen
- Keywords
- Chronic subdural hematoma, Oxygen therapy, Normobaric Oxygen, High concentration Oxygen, Pneumocephalus, Recurrence
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence, Craniosynostoses, Pneumocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High concentration Oxygen therapyProcedure or surgery
FiO2 >80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)
Control: Room Air or Low concentration OxygenProcedure or surgery
FiO2 <30% Oxygen (Delivered with 0-2L/min Nasal Cannula)
| Study group | Role | What they receive |
|---|---|---|
| High concentration Oxygen Therapy | Experimental | 12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours. Receives: Procedure: High concentration Oxygen therapy |
| Room air or low concentration oxygen | Placebo comparator | Room air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours. Receives: Procedure: Control: Room Air or Low concentration Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy
Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head
Measured: 24 hours
Secondary outcomes (16)
Modified Rankins Scale (mRS)
Functional outcomes
Measured: at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.
EuroQOL EQ-5D
Functional outcomes
Measured: at 1 month, at 3 months and at 6 months.
Glasgow Coma Scale (GCS)
Neurological examination
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Any surgically associated would infections within 6 months from the index operation
Incidence of deep wound infection, including subdural empyema
Surgical complications
Measured: Any surgically associated would infections within 6 months from the index operation
Incidence of chest complications, including chest infection
Complications
Measured: Any complications within the same admission episode for the index operation
Any complications arising from the Oxygen therapy (Adverse events)
Complications
Measured: Any complications within the same admission episode for the index operation
Barthel Index
Functional outcome
Measured: 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%
Measured: During oxygen therapy
Duration of stay at the acute neurosurgical ward (LOS)
LOS
Measured: During the same admission episode for the index operation
Discharge destination
Outcome
Measured: Upon the same admission episode for the index operation
The length of stay in secondary care
LOS
Measured: 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
Measured: at 30 days, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start26 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Yuen Chung CHAN, Chinese University of Hong Kong
- Investigators
- David YC Chan, MBBS, FRCS, Principal investigator, Chinese University of Hong KongWai S Poon, MBChB, FRCS, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725851
- Sponsor's protocol ID
- NTEC-2021-0021
- Acronym
- HOPE
- Status last verified
- Jul 2022
- First submitted
- 19 Jan 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gore PA, Maan H, Chang S, Pitt AM, Spetzler RF, Nakaji P. Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus. J Neurosurg. 2008 May;108(5):926-9. doi: 10.3171/JNS/2008/108/5/0926.
PubMed 18447708Dexter F, Reasoner DK. Theoretical assessment of normobaric oxygen therapy to treat pneumocephalus. Anesthesiology. 1996 Feb;84(2):442-7. doi: 10.1097/00000542-199602000-00024.
PubMed 8602677Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
PubMed 10639541Xu F, Liu P, Pascual JM, Xiao G, Lu H. Effect of hypoxia and hyperoxia on cerebral blood flow, blood oxygenation, and oxidative metabolism. J Cereb Blood Flow Metab. 2012 Oct;32(10):1909-18. doi: 10.1038/jcbfm.2012.93. Epub 2012 Jun 27.
PubMed 22739621Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
PubMed 19782872Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.
PubMed 20868215Chan DYC, Poon WS, Chan DTM, Mak WK, Wong GKC. Chronic subdural haematoma during the COVID-19 lockdown period: late presentation with a longer interval from the initial head injury to the final presentation and diagnosis. Chin Neurosurg J. 2021 Jan 8;7(1):4. doi: 10.1186/s41016-020-00229-7.
PubMed 33419483Chan DY, Woo PY, Mak CH, Chu AC, Li CC, Ko NM, Ng SC, Sun TF, Poon WS. Use of subdural drain for chronic subdural haematoma? A 4-year multi-centre observational study of 302 cases. J Clin Neurosci. 2017 Feb;36:27-30. doi: 10.1016/j.jocn.2016.10.039. Epub 2016 Nov 30.
PubMed 27914805Chan DY, Chan DT, Sun TF, Ng SC, Wong GK, Poon WS. The use of atorvastatin for chronic subdural haematoma: a retrospective cohort comparison study. Br J Neurosurg. 2017 Feb;31(1):72-77. doi: 10.1080/02688697.2016.1208806. Epub 2016 Nov 23.
PubMed 27881024Chan DYC, Sun TFD, Poon WS. Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation. Chinese Neurosurgical Journal. 2015; 1(1):2.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Concentration of Inspired Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma: A Randomized Controlled Trial (HOPE Study)
- ClinicalTrials.gov ID
- NCT04725851
- Acronym / sponsor ID
- HOPE / NTEC-2021-0021
- Conditions
- Chronic Subdural Hematoma, Recurrence, Oxycephaly
- Keywords
- Chronic subdural hematoma, Oxygen therapy, Normobaric Oxygen, High concentration Oxygen, Pneumocephalus, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Does post-operative high-flow oxygen improve pneumocephalus in terms of volume reduction in CSDH patients after burr-hole drainage?
- Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (radiologically) if pneumocephalus volume is reduced after oxygen therapy?
- 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?
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High concentration Oxygen Therapy | Experimental | Procedure: High concentration Oxygen therapy12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours. |
| Room air or low concentration oxygen | Placebo comparator | Procedure: Control: Room Air or Low concentration OxygenRoom air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High concentration Oxygen therapyFiO2 >80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask) | Procedure or surgery | High concentration Oxygen Therapy |
| Control: Room Air or Low concentration OxygenFiO2 <30% Oxygen (Delivered with 0-2L/min Nasal Cannula) | Procedure or surgery | Room air or low concentration oxygen |
Primary outcome
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy
Time frame: 24 hours
Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head
16 secondary outcomes
Modified Rankins Scale (mRS)
Time frame: at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.
EuroQOL EQ-5D
Time frame: at 1 month, at 3 months and at 6 months.
Glasgow Coma Scale (GCS)
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
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
Time frame: after 24 hours of oxygen therapy and 1 week after oxygen therapy
Changes in volume of subdural fluid
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
Time frame: Any surgically associated would infections within 6 months from the index operation
Incidence of deep wound infection, including subdural empyema
Time frame: Any surgically associated would infections within 6 months from the index operation
Incidence of chest complications, including chest infection
Time frame: Any complications within the same admission episode for the index operation
Any complications arising from the Oxygen therapy (Adverse events)
Time frame: Any complications within the same admission episode for the index operation
Barthel Index
Time frame: at 1 month, 3 months and 6 months
PaO2 and PaCO2 from the arterial blood gas (ABG)
Time frame: During oxygen therapy
Duration of stay at the acute neurosurgical ward (LOS)
Time frame: During the same admission episode for the index operation
Discharge destination
Time frame: Upon the same admission episode for the index operation
The length of stay in secondary care
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.
Time frame: at 30 days, 3 months and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 18447708Gore PA, Maan H, Chang S, Pitt AM, Spetzler RF, Nakaji P. Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus. J Neurosurg. 2008 May;108(5):926-9. doi: 10.3171/JNS/2008/108/5/0926.
- Background: PubMed 8602677Dexter F, Reasoner DK. Theoretical assessment of normobaric oxygen therapy to treat pneumocephalus. Anesthesiology. 1996 Feb;84(2):442-7. doi: 10.1097/00000542-199602000-00024.
- Background: PubMed 10639541Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
- Background: PubMed 22739621Xu F, Liu P, Pascual JM, Xiao G, Lu H. Effect of hypoxia and hyperoxia on cerebral blood flow, blood oxygenation, and oxidative metabolism. J Cereb Blood Flow Metab. 2012 Oct;32(10):1909-18. doi: 10.1038/jcbfm.2012.93. Epub 2012 Jun 27.
- Background: PubMed 19782872Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
- Background: PubMed 20868215Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.
- Background: PubMed 33419483Chan DYC, Poon WS, Chan DTM, Mak WK, Wong GKC. Chronic subdural haematoma during the COVID-19 lockdown period: late presentation with a longer interval from the initial head injury to the final presentation and diagnosis. Chin Neurosurg J. 2021 Jan 8;7(1):4. doi: 10.1186/s41016-020-00229-7.
- Background: PubMed 27914805Chan DY, Woo PY, Mak CH, Chu AC, Li CC, Ko NM, Ng SC, Sun TF, Poon WS. Use of subdural drain for chronic subdural haematoma? A 4-year multi-centre observational study of 302 cases. J Clin Neurosci. 2017 Feb;36:27-30. doi: 10.1016/j.jocn.2016.10.039. Epub 2016 Nov 30.
- Background: PubMed 27881024Chan DY, Chan DT, Sun TF, Ng SC, Wong GK, Poon WS. The use of atorvastatin for chronic subdural haematoma: a retrospective cohort comparison study. Br J Neurosurg. 2017 Feb;31(1):72-77. doi: 10.1080/02688697.2016.1208806. Epub 2016 Nov 23.
- BackgroundChan DYC, Sun TFD, Poon WS. Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation. Chinese Neurosurgical Journal. 2015; 1(1):2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David YC Chan, MBBS, FRCS principal investigator
Chinese University of Hong Kong
Wai S Poon, MBChB, FRCS study chair
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High concentration Oxygen therapy in people with Chronic Subdural Hematoma and Recurrence, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David YC Chan, MBBS, FRCS (852-35052624, david.yc.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the volume of pneumocephalus after 24 hours of oxygen therapy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725851, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.