Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 10:11 AM
Study NCT ID:
NCT07343232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correcting Hypocapnia in Aneurysmal Subarachnoid Hemorrhage.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D016857', 'term': 'Hypocapnia'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin Scale (mRS) >3', 'timeFrame': '90-day follow-up visit', 'description': 'The poor neurological outcome was considered to be mRs \\>3, indicating severe disability or death. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead.'}, {'measure': 'Incidence of delayed cerebral injury (DCI)', 'timeFrame': '30 days after onset', 'description': 'The presence of new focal neurological signs or a documented decrease in the level of consciousness persisting for at least 1 hour (or a drop of at least 1 point in the total Glasgow Coma Scale score), deemed to be of ischemic origin, after ruling out other causes (such as hydrocephalus, toxic-metabolic disturbances, or seizures); or identification of a new cerebral infarction on CT or MRI imaging.'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': '90-day follow-up visit', 'description': 'Cognitive function was evaluated using the Montreal Cognitive Assessment (MoCA), a standardized screening tool with scores ranging from 0 to 30, where higher scores indicate better cognitive performance and lower scores reflect greater cognitive impairment. Measure mean score or median compared between groups. And the rate of MoCA score of 20 or less between groups.'}, {'measure': 'Cerebral Vasospasm', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an expected average of 2 weeks', 'description': 'Incidence of moderate and severe radiographic cerebral vasospasm (catheter angiogram, CTA, MRA) or incidence OR moderate and severe vasospasm by transcranial doppler (TCD) criteria.'}, {'measure': 'Glasgow Coma Score(GCS)', 'timeFrame': 'Enrollment, 30 days after onset, and 90-day follow-up visit', 'description': 'The Glasgow Outcome Scale was used as secondary outcomes. The level of consciousness was assessed using the Glasgow Coma Scale (GCS), a standardized scale ranging from 3 to 15, where higher scores indicate a better neurological status (i.e., a higher level of consciousness), and lower scores reflect more severe impairment.'}, {'measure': 'The modified Rankin Scale (mRS)', 'timeFrame': '30 days after onset', 'description': 'Shift analysis of mRS scores at 30 days after onset. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead. The higher scores indicate worse functional disability and lower scores reflect better functional independence.'}, {'measure': 'modified Rankin Scale (mRS)', 'timeFrame': '30 days after onset', 'description': 'The rate of modified Rankin Scale (mRS) score \\> 3. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead. The higher scores indicate worse functional disability and lower scores reflect better functional independence.'}, {'measure': 'Barthel Index (BI) score', 'timeFrame': '90-day follow-up visit', 'description': 'Activities of daily living were evaluated using the Barthel Index (BI), a functional assessment scale ranging from 0 to 100, where higher scores indicate greater independence in daily activities and lower scores reflect more severe functional dependence.'}, {'measure': 'All-cause mortality', 'timeFrame': '90-day follow-up visit', 'description': 'Death caused by any reason.'}, {'measure': 'Complication of severe dependent survival', 'timeFrame': '90-day follow-up visit', 'description': 'eg, chest or other infections'}, {'measure': 'Treated aneurysm rebleeding', 'timeFrame': '90-day follow-up visit', 'description': 'Treated aneurysm rebleeding'}, {'measure': 'Probable or definite bleed from another aneurysm', 'timeFrame': '90-day follow-up visit', 'description': 'Probable or definite bleed from another aneurysm'}, {'measure': 'Incidence of adverse events', 'timeFrame': '90-day follow-up visit', 'description': 'Ischaemic stroke, Other intracranial haemorrhage, Cardiac, Cancer, Suicide, Renal failure, Infections not related to dependent survival, Other causes (eg, trauma, perforated ulcer, pulmonary embolus, neurodegenerative)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aneurysmal Subarachnoid Hemorrhage (aSAH)', 'Hypocapnia'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage (aSAH)']}, 'referencesModule': {'references': [{'pmid': '40532319', 'type': 'RESULT', 'citation': 'Yang L, Yuan D, Luo Z, Li Y, Zhu X. The low-flow mask oxygen could be a more effective, comfortable, and easy-to-follow treatment for psychogenic hyperventilation syndrome: A double-blind, randomized controlled trial. Int Emerg Nurs. 2025 Aug;81:101636. doi: 10.1016/j.ienj.2025.101636. Epub 2025 Jun 17.'}, {'pmid': '34584136', 'type': 'RESULT', 'citation': 'Darkwah Oppong M, Wrede KH, Muller D, Santos AN, Rauschenbach L, Dinger TF, Ahmadipour Y, Pierscianek D, Chihi M, Li Y, Deuschl C, Sure U, Jabbarli R. PaCO2-management in the neuro-critical care of patients with subarachnoid hemorrhage. Sci Rep. 2021 Sep 28;11(1):19191. doi: 10.1038/s41598-021-98462-2.'}, {'pmid': '34331211', 'type': 'RESULT', 'citation': 'Cai G, Zhang X, Ou Q, Zhou Y, Huang L, Chen S, Zeng H, Jiang W, Wen M. Optimal Targets of the First 24-h Partial Pressure of Carbon Dioxide in Patients with Cerebral Injury: Data from the MIMIC-III and IV Database. Neurocrit Care. 2022 Apr;36(2):412-420. doi: 10.1007/s12028-021-01312-2. Epub 2021 Jul 30.'}, {'pmid': '39640813', 'type': 'RESULT', 'citation': 'Su R, Li HL, Wang YM, Zhang L, Zhou JX. Association of dynamic changes in arterial partial pressure of carbon dioxide with neurological outcomes in aneurysmal subarachnoid hemorrhage. Heliyon. 2024 Oct 10;10(20):e39197. doi: 10.1016/j.heliyon.2024.e39197. eCollection 2024 Oct 30.'}, {'pmid': '19965840', 'type': 'RESULT', 'citation': 'Carrera E, Schmidt JM, Fernandez L, Kurtz P, Merkow M, Stuart M, Lee K, Claassen J, Sander Connolly E, Mayer SA, Badjatia N. Spontaneous hyperventilation and brain tissue hypoxia in patients with severe brain injury. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):793-7. doi: 10.1136/jnnp.2009.174425. Epub 2009 Dec 3.'}, {'pmid': '17205016', 'type': 'RESULT', 'citation': 'Coles JP, Fryer TD, Coleman MR, Smielewski P, Gupta AK, Minhas PS, Aigbirhio F, Chatfield DA, Williams GB, Boniface S, Carpenter TA, Clark JC, Pickard JD, Menon DK. Hyperventilation following head injury: effect on ischemic burden and cerebral oxidative metabolism. Crit Care Med. 2007 Feb;35(2):568-78. doi: 10.1097/01.CCM.0000254066.37187.88.'}, {'pmid': '12352026', 'type': 'RESULT', 'citation': 'Coles JP, Minhas PS, Fryer TD, Smielewski P, Aigbirihio F, Donovan T, Downey SP, Williams G, Chatfield D, Matthews JC, Gupta AK, Carpenter TA, Clark JC, Pickard JD, Menon DK. Effect of hyperventilation on cerebral blood flow in traumatic head injury: clinical relevance and monitoring correlates. Crit Care Med. 2002 Sep;30(9):1950-9. doi: 10.1097/00003246-200209000-00002.'}, {'pmid': '38294526', 'type': 'RESULT', 'citation': 'Robba C, Battaglini D, Abbas A, Sarrio E, Cinotti R, Asehnoune K, Taccone FS, Rocco PR, Schultz MJ, Citerio G, Stevens RD, Badenes R; ENIO collaborators. Clinical practice and effect of carbon dioxide on outcomes in mechanically ventilated acute brain-injured patients: a secondary analysis of the ENIO study. Intensive Care Med. 2024 Feb;50(2):234-246. doi: 10.1007/s00134-023-07305-3. Epub 2024 Jan 31.'}, {'pmid': '25846710', 'type': 'RESULT', 'citation': 'Williamson CA, Sheehan KM, Tipirneni R, Roark CD, Pandey AS, Thompson BG, Rajajee V. The Association Between Spontaneous Hyperventilation, Delayed Cerebral Ischemia, and Poor Neurological Outcome in Patients with Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):330-8. doi: 10.1007/s12028-015-0138-5.'}]}, 'descriptionModule': {'briefSummary': 'Based on the clinical observation that over half of the patients in the management of aneurysmal subarachnoid hemorrhage(aSAH) present with spontaneous hyperventilation, which is significantly associated with delayed cerebral ischemia and poor neurological outcomes, this prospective pilot study is designed to investigate the safety and efficacy of normobaric facemask oxygen for hypocapnia in aSAH.', 'detailedDescription': 'Spontaneous hyperventilation (SH) is highly prevalent following aneurysmal subarachnoid hemorrhage (aSAH) and is significantly associated with poor neurological outcomes.The core pathophysiological mechanism involves hypocapnia induced by hyperventilation, which triggers cerebral vasoconstriction and consequently leads to a decrease in cerebral blood flow (CBF).Although this response may transiently reduce intracranial pressure, persistent cerebral vasoconstriction markedly increases the risk of delayed cerebral ischemia (DCI) and secondary brain injury. Therefore, maintaining the arterial partial pressure of carbon dioxide (PaCO2) within the physiological range of mmHg is recommended to minimize the detrimental effects of hypocapnia.\n\nCurrently, there is a lack of standardized management strategies for hypocapnia resulting from SH after aSAH. Based on physiological principles, low-flow (\\<5 L/min) oxygen delivery via a facemask may effectively correct hypocapnia by promoting the rebreathing of carbon dioxide within the dead space of the facemask.10 A randomized controlled trial investigating psychogenic hyperventilation syndrome provides preliminary evidence for this approach, demonstrating that low-flow (3 L/min) facemask oxygen therapy can relieve symptoms more rapidly and improve patient comfort compared to traditional breathing training.11\n\nHowever, high-level evidence regarding the safety, efficacy, and impact on neurological outcomes of using low-flow facemask oxygen therapy (functioning as a rebreathing mask) as a targeted intervention for correcting hypocapnia in aSAH patients remains scarce. Consequently, this proof-of-concept prospective study aims to systematically evaluate the operational safety and clinical effectiveness of rebreathing facemask oxygen therapy for correcting hypocapnia in patients with aSAH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Aneurysmal Subarachnoid Hemorrhage Patients with Hypocapnia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Confirmed diagnosis of aneurysmal subarachnoid hemorrhage (aSAH), with the presence of an aneurysm verified by computed tomography (CT), CT angiography (CTA), or digital subtraction angiography (DSA).\n3. Hunt-Hess grade II-IV.\n4. Presence of hypocapnia on arterial blood gas analysis, defined as PaCO2 \\< 35 mmH;\n5. PaO2 \\> 90 mmHg.\n\nExclusion Criteria:\n\n1. Presence of brain herniation or refractory intracranial hypertension, defined as a baseline intracranial pressure (ICP) \\> 25 mmHg that responds poorly to conventional ICP-lowering therapy;\n2. Primary respiratory diseases (e.g., chronic obstructive pulmonary disease, severe asthma) known to cause chronically elevated baseline PaCO2;\n3. Severe acid-base disturbances other than respiratory alkalosis.\n4. Severe cardiac insufficiency, severe hepatic or renal dysfunction, malignant tumors, or other severe comorbidities that significantly impact prognosis;\n5. Before the onset of the disease, the mRS score was greater than 2, and there were other factors causing disability.\n6. Life expectancy \\< 3 months;\n7. Any other condition deemed by the investigator to pose a high risk warranting exclusion.'}, 'identificationModule': {'nctId': 'NCT07343232', 'briefTitle': 'Correcting Hypocapnia in Aneurysmal Subarachnoid Hemorrhage.', 'organization': {'class': 'OTHER', 'fullName': 'The Chinese University of Hong Kong, Shenzhen'}, 'officialTitle': 'Safety and Efficacy of Normobaric Facemask Oxygen for Hypocapnia in Aneurysmal Subarachnoid Hemorrhage(FOCAL): A Prospective, Multicenter, Proof-of-concept Pilot Study', 'orgStudyIdInfo': {'id': 'CUHKShenzhen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normobaric Facemask Oxygen', 'description': 'Patients who received oxygen via a rebreathing facemask (ensuring no one-way valve is present), with a fractional inspired oxygen (FiO2) of 25-40% and an oxygen flow rate of ≤ 5 L/min.', 'interventionNames': ['Behavioral: Normobaric Facemask Oxygen']}, {'label': 'Control group', 'description': 'Patients who received oxygen via nasal cannula or did not receive oxygen therapy.', 'interventionNames': ['Behavioral: control group']}], 'interventions': [{'name': 'Normobaric Facemask Oxygen', 'type': 'BEHAVIORAL', 'description': 'Oxygen is to be delivered via a rebreathing facemask (ensuring no one-way valve is present), with a fractional inspired oxygen (FiO2) of 25-41% and an oxygen flow rate of ≤ 5 L/min.\n\nThe goals are to maintain patient SpO2 \\> 95%, PaCO2 between 35-42 mmHg, and, where feasible (particularly in centers with the capability for monitoring), an intracranial pressure (ICP) of \\< 15 mmHg.', 'armGroupLabels': ['Normobaric Facemask Oxygen']}, {'name': 'control group', 'type': 'BEHAVIORAL', 'description': "Using nasal cannula for oxygen inhalation or not using oxygen inhalation at all. Monitor and record the patient's SpO2, systolic blood pressure, diastolic blood pressure, PaCO2, and also monitor the intracranial pressure (ICP) at a center with monitoring capabilities.", 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xinyu Yang, MD', 'role': 'CONTACT', 'email': 'cuhkshzhyang@outlook.com', 'phone': '18622766038'}, {'name': 'Xinyu Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Medicine Chinese University of Hong Kong-SHENZHEN', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Xinyu Yang, MD', 'role': 'CONTACT', 'email': 'cuhkshzhyang@outlook.com', 'phone': '18622766038'}], 'overallOfficials': [{'name': 'Renzhi Wang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CUHK-Shenzhen'}, {'name': 'Xinyu Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUHK-Shenzhen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Chinese University of Hong Kong, Shenzhen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of department', 'investigatorFullName': 'Renzhi Wang', 'investigatorAffiliation': 'The Chinese University of Hong Kong, Shenzhen'}}}}