Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-31 @ 7:49 AM
Study NCT ID:
NCT00856232
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}, {'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'veysmabo@umdnj.edu', 'phone': '732-235-8717', 'title': 'Dr. Boris Veysman', 'organization': 'UMDNJ'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited number of subjects due to difficulty with recruitment'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Therapy', 'description': 'Standard emergency department evaluation and treatment for headache', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Air at 15L/Min', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Oxygen', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Length of Stay in the Emergency Department(Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy', 'description': 'Standard emergency department evaluation and treatment for headache'}, {'id': 'OG001', 'title': 'Medical Air at 15L/Min', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache'}, {'id': 'OG002', 'title': 'Oxygen at 15 L / Min', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache'}], 'classes': [{'categories': [{'measurements': [{'value': '177.5', 'spread': '109', 'groupId': 'OG000'}, {'value': '210.7', 'spread': '134.9', 'groupId': 'OG001'}, {'value': '118.7', 'spread': '145.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study duration', 'description': "Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-08'}, {'type': 'PRIMARY', 'title': 'Time to Relief (Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy', 'description': 'Standard emergency department evaluation and treatment for headache'}, {'id': 'OG001', 'title': 'Air at 15L/Min', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache'}, {'id': 'OG002', 'title': 'Oxygen', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'spread': '84.4', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '45.3', 'groupId': 'OG001'}, {'value': '35.4', 'spread': '29.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'study duration', 'description': 'Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Therapy', 'description': 'Standard emergency department evaluation and treatment for headache'}, {'id': 'FG001', 'title': 'Air at 15L/Min', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache'}, {'id': 'FG002', 'title': 'Oxygen', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Therapy', 'description': 'Standard emergency department evaluation and treatment for headache'}, {'id': 'BG001', 'title': 'Air at 15L/Min', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache'}, {'id': 'BG002', 'title': 'Oxygen', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Age data not collected as part of IRB protocol', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'gender data not collected as part of IRB protocol', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2009-03-04', 'resultsFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-22', 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relief (Min)', 'timeFrame': 'study duration', 'description': 'Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay in the Emergency Department(Min)', 'timeFrame': 'Study duration', 'description': "Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Headache', 'Cephalgia', 'Migraine'], 'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': "This study will randomly assign emergency department patients seeking treatment for a headache to one of three groups. The first group will receive standard emergency care as determined by the treating physician, the second group will breathe high flow air by facemask for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15 minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10, 15 and 30 minutes after it's begun about the intensity of their headache and how much relief they are experiencing from their treatment. Concentration of carbon dioxide exhaled by patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the patients in groups 2 and 3 will continue with standard emergency care, which can include any treatment their physician sees fit. Patients in all three groups will receive a stopwatch in the beginning of their emergency department visit and record the total extent of time their headache will take to resolve.", 'detailedDescription': 'Thorough description provided in brief summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.\n\nExclusion Criteria:\n\n* patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure\\_\\_\\_\\_\\_\\_\\_ O2 saturation 94% or less on room air on triage vitals \\_\\_\\_\\_\\_\\_ patient arrives on supplemental oxygen\\_\\_\\_\\_\\_\\_\\_ patient reports shortness of breath\\_\\_\\_\\_\\_\\_\\_\n* patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD\\_\\_\\_\\_\\_\\_\\_ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)\\_\\_\\_\\_\\_\\_\\_ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)\\_\\_\\_\\_\\_\n* patients unable to tolerate the gas treatment: patient not able to tolerate a face mask\\_\\_\\_\\_\\_\\_\\_ patient requests immediate treatment with another preferred therapeutic agent\\_\\_\\_\\_\\_\\_\\_\n* treating physician or nurse request to discontinue the study at any point\\_\\_\\_\\_\\_\\_\\_\n* patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder\\_\\_\\_\\_\\_\\_\\_ patient not awake and alert\\_\\_\\_\\_\\_\\_\\_ patient not oriented to self, month and year, and current location\\_\\_\\_\\_\\_\\_\\_ patient unwilling or unable to fully participate in the research associate interview and consent process\\_\\_\\_\\_\\_\\_\\_\n* patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor\\_\\_\\_\\_\\_\\_\\_ current headache began after trauma\\_\\_\\_\\_\\_\\_\\_ current headache began after using elicit drugs\\_\\_\\_\\_\\_\\_\\_\n* patients who are at high risk for intracranial infection fever \\> 100.4 F on triage vitals\\_\\_\\_\\_\\_\\_\\_ complaining of recent onset neck stiffness\\_\\_\\_\\_\\_\\_\\_\n* patients who are at high risk for extracranial head pathology ear pain or drainage\\_\\_\\_\\_\\_\\_\\_ tooth or gum pain\\_\\_\\_\\_\\_\\_\\_ headache localized to a skin lesion on the head\\_\\_\\_\\_\\_\\_\n* patient is potentially critically ill active bleeding from any source\\_\\_\\_\\_\\_\\_\\_ heart rate \\<60 or \\>130 on triage vitals\\_\\_\\_\\_\\_\\_\\_ systolic blood pressure \\<90 or \\>180 on triage vitals\\_\\_\\_\\_\\_\\_\\_ respiratory rate \\< 10 or \\>30 on triage vitals\\_\\_\\_\\_\\_\\_\\_\n* patient is younger than 21\\_\\_\\_\\_\\_\\_\\_\n* patients who know or suspect they are pregnant \\_\\_\\_\\_\\_'}, 'identificationModule': {'nctId': 'NCT00856232', 'briefTitle': 'Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department', 'orgStudyIdInfo': {'id': '0220080056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard therapy', 'description': 'Standard emergency department evaluation and treatment for headache'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Medical Air', 'description': 'Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache', 'interventionNames': ['Biological: Medical Air']}, {'type': 'EXPERIMENTAL', 'label': 'Oxygen', 'description': 'Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache', 'interventionNames': ['Biological: Oxygen']}], 'interventions': [{'name': 'Medical Air', 'type': 'BIOLOGICAL', 'description': 'Compressed medical air', 'armGroupLabels': ['Medical Air']}, {'name': 'Oxygen', 'type': 'BIOLOGICAL', 'description': 'Medical Oxygen', 'armGroupLabels': ['Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08801', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital Emergency Department', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Boris D Veysman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'rwjms-ed', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}