Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT01242358
Status:
UNKNOWN
Last Update Posted:
2011-11-22
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capnography During Percutaneous Endoscopic Gastrostomy (PEG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019296', 'term': 'Capnography'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-20', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-16', 'lastUpdatePostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h'}], 'secondaryOutcomes': [{'measure': 'Further complications', 'timeFrame': 'From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypoxaemia - capnography - integrated pulmonary index - PEG'], 'conditions': ['In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.']}, 'referencesModule': {'references': [{'pmid': '12024135', 'type': 'RESULT', 'citation': 'Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years and older\n* Scheduled for PEG with propofol sedation\n\nExclusion Criteria:\n\n* No informed consent\n* ASA V\n* Emergency endoscopy\n* Preexisting hypotension, bradycardia or hypoxemia'}, 'identificationModule': {'nctId': 'NCT01242358', 'acronym': 'PEG', 'briefTitle': 'Capnography During Percutaneous Endoscopic Gastrostomy (PEG)', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.', 'orgStudyIdInfo': {'id': 'Capno-PEG 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capnography', 'description': 'Arm with capnographic monitoring', 'interventionNames': ['Device: Capnography']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard monitoring', 'description': 'Standard monitoring', 'interventionNames': ['Device: Standard monitoring']}], 'interventions': [{'name': 'Capnography', 'type': 'DEVICE', 'description': 'Capnographic monitoring', 'armGroupLabels': ['Capnography']}, {'name': 'Standard monitoring', 'type': 'DEVICE', 'description': 'Standard monitoring', 'armGroupLabels': ['Standard monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44892', 'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andrea Riphaus, MD', 'role': 'CONTACT', 'email': 'ariphaus@web.de', 'phone': '+49-234-299', 'phoneExt': '80200'}, {'name': 'Andrea Riphaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruhr Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '81675', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan von Delius,, MD', 'role': 'CONTACT'}, {'name': 'Stefan von Delius, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technische Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '65191', 'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Till Wehrmann, Prof.', 'role': 'CONTACT'}, {'name': 'Till Wehrmann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsche Klinik für Diagnostik', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'centralContacts': [{'name': 'Andrea Riphaus, MD', 'role': 'CONTACT', 'email': 'ariphaus@web.de', 'phone': '+49-234-299', 'phoneExt': '80200'}], 'overallOfficials': [{'name': 'Andrea Riphaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr-Universität Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical value of capnography During Percutaneous Endoscopic Gastrostomy (PEG)', 'investigatorFullName': 'Andrea Riphaus', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}