Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT03402594
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Oxygen Therapy and Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen desaturation index', 'timeFrame': 'In the first 24 hours of study period', 'description': 'The number of times per hour that the oxygen saturation measured by pulse oximetry drop from baseline more than 4% for at least 10 seconds'}], 'secondaryOutcomes': [{'measure': 'Mean oxygen saturation', 'timeFrame': 'In the first 24 hours of study period'}, {'measure': 'Lowest oxygen saturation', 'timeFrame': 'In the first 24 hours of study period'}, {'measure': 'The number of subjects with oxygen desaturation', 'timeFrame': 'In the first 24 hours of study period'}, {'measure': 'Percentages of cumulative time of oxygen desaturation', 'timeFrame': 'In the first 24 hours of study period'}, {'measure': 'NIHSS changes', 'timeFrame': 'at the 7th day of admission or at discharge date', 'description': 'The NIHSS at randomization minus the NIHSS at the 7th day of admission'}, {'measure': 'The number of subjects with NIHSS improvement by 4 or more', 'timeFrame': 'at the 7th day of admission or at discharge date'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High flow oxygen therapy', 'Oxygen desaturation index', 'Acute ischemic stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Hypoxemia is common in acute ischemic stroke and associated with neurological deterioration and mortality. However, the benefit of oxygen therapy is controversial. Severity of stroke may affect the benefit of oxygen supplementation. Abnormal breathing patterns are commonly found among stroke patients and may increase the risk of hypoxemia. High flow nasal cannula (HFNC) has several advantages from controllable fraction of inspired oxygen (FiO2), reduction of nasopharyngeal resistance and positive end expiratory pressure effect. In this study, we aimed to assess the therapeutic effect of HFNC on oxygen desaturation index (ODI) and neurological outcomes in stroke patients with moderate and severe severities, compared with no and low flow oxygen supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of 18 or more\n2. Clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke\n3. Presentation within 72 hours after the stroke onset\n4. National of Health Stroke Scale (NIHSS) of 5 or more,\n5. Limb weakness defined as motor power grade of 4 or less,\n6. Able to give informed consent, or the next of kin was willing to give assent\n\nExclusion Criteria:\n\n1. Recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation\n2. Recognized contraindications for oxygen treatment including chronic hypercapnia and type II respiratory failure\n3. Subjects with previous diagnosis of obstructive sleep apnea (OSA) or highly suspicious of OSA, screened by STOPBANG score of 5 or more'}, 'identificationModule': {'nctId': 'NCT03402594', 'briefTitle': 'High Flow Oxygen Therapy and Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '436/59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No oxygen', 'description': 'No oxygen supplementation given'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low flow oxygen', 'description': 'Oxygen cannula with a flow rate of 2 liter/minute', 'interventionNames': ['Device: Low flow oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'High flow oxygen', 'description': 'Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute', 'interventionNames': ['Device: High flow oxygen']}], 'interventions': [{'name': 'High flow oxygen', 'type': 'DEVICE', 'description': 'Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute', 'armGroupLabels': ['High flow oxygen']}, {'name': 'Low flow oxygen', 'type': 'DEVICE', 'description': 'Oxygen cannula with a flow rate of 2 liter/minute', 'armGroupLabels': ['Low flow oxygen']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}