Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 12:31 PM
Study NCT ID:
NCT01587157
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2012-04-25', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)'}], 'secondaryOutcomes': [{'measure': 'overall number of detected episodes of apnea'}, {'measure': 'the occurrences of oxygen desaturation and hypoxemia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Apnea', 'Hypoxemia', 'Complications']}, 'descriptionModule': {'briefSummary': 'Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea. The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>=18\n* Scheduled for PTCD with midazolam and propofol sedation\n\nExclusion Criteria:\n\n* age less than 18 years\n* ASA class V\n* allergy to narcotic drugs\n* pregnancy\n* pre-existing hypotension, bradycardia or hypoxemia'}, 'identificationModule': {'nctId': 'NCT01587157', 'briefTitle': 'Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'orgStudyIdInfo': {'id': '20042012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'capnography', 'interventionNames': ['Procedure: capnography']}], 'interventions': [{'name': 'capnography', 'type': 'PROCEDURE', 'armGroupLabels': ['capnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}