Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT01638793
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2012-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capnographic Monitoring of Propofol-sedation During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-24', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxia (SO2 <90%)', 'description': 'Study objective is to evaluate if a reduction of hypoxic events (SO2 \\<90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation'}], 'secondaryOutcomes': [{'measure': 'Severe Hypoxia (SO2 <85%)', 'description': 'Evaluate events of severe hypoxia (SO2 \\< 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)'}, {'measure': 'Time to hypoxia', 'description': 'Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.'}, {'measure': 'Hypoxia in relation to sedation', 'description': 'Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.'}, {'measure': 'Vegetative Symptoms', 'description': 'Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for colonoscopy\n* Patient wishing sedation during colonoscopy\n* ≥ 18 years of age\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)\n* Non-contractually capable persons\n* Pregnancy\n* Lactation'}, 'identificationModule': {'nctId': 'NCT01638793', 'briefTitle': 'Capnographic Monitoring of Propofol-sedation During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Capnographic Monitoring of Propofol-sedation During Colonoscopy', 'orgStudyIdInfo': {'id': 'JWGUHMED1-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capnography', 'description': 'Capnographic respiration monitoring', 'interventionNames': ['Device: Microcap (Oridion, Needham, MA, USA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulse-Oxymetry', 'description': 'pulse-oxymetric respiration monitoring', 'interventionNames': ['Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)']}], 'interventions': [{'name': 'Microcap (Oridion, Needham, MA, USA)', 'type': 'DEVICE', 'armGroupLabels': ['Capnography']}, {'name': 'Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)', 'type': 'DEVICE', 'armGroupLabels': ['Pulse-Oxymetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe-Universität', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '60596', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Praxisklinik am Staedel', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Mireen Friedrich-Rust, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum der J. W. Goethe-Universität Frankfurt am Main'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}}}}