Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT00875134
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2009-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing of the Apnea Prevention Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2009-04-02', 'studyFirstSubmitQcDate': '2009-04-02', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in treating respiratory depression', 'timeFrame': 'seconds after desaturation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Depression', 'Elective Surgery']}, 'descriptionModule': {'briefSummary': 'This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgical patients\n\nExclusion Criteria:\n\n* Refusal to consent to study'}, 'identificationModule': {'nctId': 'NCT00875134', 'briefTitle': 'Testing of the Apnea Prevention Device', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Testing of the Apnea Prevention Device', 'orgStudyIdInfo': {'id': '10-06-54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verbal prompt, cutaneous stimulation', 'description': 'Patient receives either or both a verbal stimulus or cutaneous stimulus', 'interventionNames': ['Other: Verbal prompt', 'Other: Skin Stimulus']}], 'interventions': [{'name': 'Verbal prompt', 'type': 'OTHER', 'description': 'Patient hears a voice recording', 'armGroupLabels': ['Verbal prompt, cutaneous stimulation']}, {'name': 'Skin Stimulus', 'type': 'OTHER', 'description': 'Patient receives either a skin stimulus', 'armGroupLabels': ['Verbal prompt, cutaneous stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark H. Zornow', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}