Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03004235
Status:
TERMINATED
Last Update Posted:
2019-08-12
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suspected Cases of Carbon Monoxide Poisoning in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'IRB is reviewing all studies at the institution and are on hold', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-22', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device', 'timeFrame': 'Through study completion, an average of 2 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carbon Monoxide Poisoning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants will be selected based on symptoms in the Emergency Department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known or suspected carbon monoxide poisoning\n\nExclusion Criteria:\n\n* Less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT03004235', 'briefTitle': 'Suspected Cases of Carbon Monoxide Poisoning in the ED', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'ED Data Collection of Suspected Carbon Monoxide Poisoning', 'orgStudyIdInfo': {'id': 'QATP2978'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational data collection', 'type': 'DEVICE', 'description': 'Observational data collection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'James Miner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}