Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-29 @ 4:59 PM
Study NCT ID:
NCT04725851
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D003398', 'term': 'Craniosynostoses'}, {'id': 'D011007', 'term': 'Pneumocephalus'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013580', 'term': 'Synostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001930', 'term': 'Brain Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrence rate in BILATERAL Chronic Subdural Hematoma (CSDH)', 'timeFrame': 'Within six months from the index operation', 'description': 'Bilateral (CSDH)'}, {'measure': 'Volumetric reduction in pneumocephalus in BILATERAL Chronic Subdural Hematoma (CSDH) after Oxygen therapy', 'timeFrame': 'Within 24 hours after Oxygen therapy', 'description': 'Bilateral (CSDH)'}, {'measure': 'Improvement in mRS for BILATERAL Chronic Subdural Hematoma (CSDH)', 'timeFrame': 'at 1 month, 3 months and 6 months', 'description': 'Functional outcome in bilateral CSDH'}], 'primaryOutcomes': [{'measure': 'Changes in the volume of pneumocephalus after 24 hours of oxygen therapy', 'timeFrame': '24 hours', 'description': 'Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head'}], 'secondaryOutcomes': [{'measure': 'Modified Rankins Scale (mRS)', 'timeFrame': 'at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.', 'description': 'Functional outcomes'}, {'measure': 'EuroQOL EQ-5D', 'timeFrame': 'at 1 month, at 3 months and at 6 months.', 'description': 'Functional outcomes'}, {'measure': 'Glasgow Coma Scale (GCS)', 'timeFrame': 'On admission, at 1 month, at 3 months and at 6 months.', 'description': 'Neurological examination'}, {'measure': 'Recurrence rate, as defined by reoperation rate due to symptomatic recurrence', 'timeFrame': '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.', 'description': 'Surgical complications'}, {'measure': 'Changes in brain volume re-expansion', 'timeFrame': 'after 24 hours of oxygen therapy and 1 week after oxygen therapy', 'description': 'Volumetric measurement from Computed Tomographic (CT) scan for the Head'}, {'measure': 'Changes in volume of subdural fluid', 'timeFrame': '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.', 'description': 'Volumetric measurement from Computed Tomographic (CT) scan for the Head'}, {'measure': 'Incidence of superficial wound infection', 'timeFrame': 'Any surgically associated would infections within 6 months from the index operation', 'description': 'Surgical complications'}, {'measure': 'Incidence of deep wound infection, including subdural empyema', 'timeFrame': 'Any surgically associated would infections within 6 months from the index operation', 'description': 'Surgical complications'}, {'measure': 'Incidence of chest complications, including chest infection', 'timeFrame': 'Any complications within the same admission episode for the index operation', 'description': 'Complications'}, {'measure': 'Any complications arising from the Oxygen therapy (Adverse events)', 'timeFrame': 'Any complications within the same admission episode for the index operation', 'description': 'Complications'}, {'measure': 'Barthel Index', 'timeFrame': 'at 1 month, 3 months and 6 months', 'description': 'Functional outcome'}, {'measure': 'PaO2 and PaCO2 from the arterial blood gas (ABG)', 'timeFrame': 'During oxygen therapy', 'description': 'Blood taking for ABG when judged to be necessary by the treating physician or when there is desaturation to SaO2 \\< 93%'}, {'measure': 'Duration of stay at the acute neurosurgical ward (LOS)', 'timeFrame': 'During the same admission episode for the index operation', 'description': 'LOS'}, {'measure': 'Discharge destination', 'timeFrame': 'Upon the same admission episode for the index operation', 'description': 'Outcome'}, {'measure': 'The length of stay in secondary care', 'timeFrame': 'Upon transferal to the secondary care from the same admission episode for the index operation', 'description': 'LOS'}, {'measure': 'Mortality rate at 30 days, 3 months and 6 months.', 'timeFrame': 'at 30 days, 3 months and 6 months.', 'description': 'Death rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic subdural hematoma', 'Oxygen therapy', 'Normobaric Oxygen', 'High concentration Oxygen', 'Pneumocephalus', 'Recurrence'], 'conditions': ['Chronic Subdural Hematoma', 'Recurrence', 'Oxycephaly']}, 'referencesModule': {'references': [{'pmid': '18447708', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8602677', 'type': 'BACKGROUND', 'citation': 'Dexter 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.'}, {'pmid': '10639541', 'type': 'BACKGROUND', 'citation': 'Greif 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.'}, {'pmid': '22739621', 'type': 'BACKGROUND', 'citation': 'Xu 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.'}, {'pmid': '19782872', 'type': 'BACKGROUND', 'citation': 'Santarius 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.'}, {'pmid': '20868215', 'type': 'BACKGROUND', 'citation': 'Miranda 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.'}, {'pmid': '33419483', 'type': 'BACKGROUND', 'citation': 'Chan 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.'}, {'pmid': '27914805', 'type': 'BACKGROUND', 'citation': 'Chan 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.'}, {'pmid': '27881024', 'type': 'BACKGROUND', 'citation': 'Chan 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.'}, {'type': 'BACKGROUND', 'citation': 'Chan 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPneumocephalus 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.\n\nBilateral CSDH has a different prognosis and is associated with a poorer outcome.\n\nIn 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.\n\nHyperoxia with oxygen therapy has shown to be safe with minimal changes to the cerebral blood flow (CBF) from functional magnetic resonance imaging (fMRI).\n\nResearch Questions\n\n1. Does post-operative high-flow oxygen improve pneumocephalus in terms of volume reduction in CSDH patients after burr-hole drainage?\n2. Does post-operative high-flow oxygen reduce the recurrence rate of CSDH (radiologically) if pneumocephalus volume is reduced after oxygen therapy?\n3. 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?\n4. Does post-operative high-flow oxygen improve CSDH patients' functional outcome in terms of modified Rankin Scale (mRS) at 3 months and 6 months?\n\nHypothesis 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.\n\nAim 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.\n\nStudy Design Prospective randomized 1:1 parallel-arm study\n\nMethods 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).\n\nNon-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).\n\nInterim data analysis would be performed and the study would be terminated if a significant difference in the primary outcome is observed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age greater than or equal to 18 years-old.\n2. Presence of chronic subdural haematoma (CSDH) as diagnosed radiologically either by computed tomography (CT) brain scan or magnetic resonance imaging (MRI).\n3. Treatment of CSDH by burr-hole evacuation.\n4. Presence of post-operative pneumocephalus, as evidenced from post-operative CT Brain or MRI brain\n5. 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.\n\nExclusion Criteria:\n\n1. Presence of pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD) and hence not suitable for oxygen therapy.\n2. 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.\n3. CSDH arising from secondary causes, such as intracranial hypotension, thrombocytopenia, etc.\n4. 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).\n5. Patients that need an additional procedure e.g. epidural blood patch, etc.\n6. 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.\n7. Patients already on long-term steroid for pre-existing medical conditions.\n8. Participation in other clinical trials within four weeks upon recruitment.\n9. Pregnancy or on breastfeeding.\n10. Any other reasons that the researchers consider the patients to be unsuitable."}, 'identificationModule': {'nctId': 'NCT04725851', 'acronym': 'HOPE', 'briefTitle': 'High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'High Concentration of Inspired Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma: A Randomized Controlled Trial (HOPE Study)', 'orgStudyIdInfo': {'id': 'NTEC-2021-0021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High concentration Oxygen Therapy', 'description': '12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours.', 'interventionNames': ['Procedure: High concentration Oxygen therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Room air or low concentration oxygen', 'description': 'Room air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours.', 'interventionNames': ['Procedure: Control: Room Air or Low concentration Oxygen']}], 'interventions': [{'name': 'High concentration Oxygen therapy', 'type': 'PROCEDURE', 'description': 'FiO2 \\>80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)', 'armGroupLabels': ['High concentration Oxygen Therapy']}, {'name': 'Control: Room Air or Low concentration Oxygen', 'type': 'PROCEDURE', 'description': 'FiO2 \\<30% Oxygen (Delivered with 0-2L/min Nasal Cannula)', 'armGroupLabels': ['Room air or low concentration oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'David YC Chan, MBBS, FRCS', 'role': 'CONTACT', 'email': 'david.yc.chan@cuhk.edu.hk', 'phone': '35052542', 'phoneExt': '2542'}, {'name': 'Wai Poon, MBChB, FRCS', 'role': 'CONTACT', 'email': 'wpoon@surgery.cuhk.edu.hk', 'phone': '35051316'}, {'name': 'Wai S Poon, MBChB, FRCS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephanie CP Ng, MPhil, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Danny TM Chan, MBChB, FRCS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'George KC Wong, MD, FRCS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'David YC Chan, MBBS, FRCS', 'role': 'CONTACT', 'email': 'david.yc.chan@cuhk.edu.hk', 'phone': '852-35052624'}, {'name': 'Wai S Poon, MBChB, FRCS', 'role': 'CONTACT', 'email': 'wpoon@surgery.cuhk.edu.hk', 'phone': '852-35051316'}], 'overallOfficials': [{'name': 'David YC Chan, MBBS, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}, {'name': 'Wai S Poon, MBChB, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Dr. David Yuen Chung CHAN', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}