Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT01237756
Status:
COMPLETED
Last Update Posted:
2010-11-10
First Post:
2010-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Impedance Tomography for Endotracheal Tube Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determination of proper endotracheal tube placement', 'timeFrame': 'endotracheal tube placement is immediately verified after endotracheal intubation with fluoroscopy and electrical impedance tomography during the general anesthesia for cardiac catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric anesthesia', 'endotracheal tube', 'electrical impedance tomography', 'misplacement', 'endobronchial'], 'conditions': ['Endotracheal Tube Placement']}, 'referencesModule': {'references': [{'pmid': '18559350', 'type': 'BACKGROUND', 'citation': 'Steinmann D, Stahl CA, Minner J, Schumann S, Loop T, Kirschbaum A, Priebe HJ, Guttmann J. Electrical impedance tomography to confirm correct placement of double-lumen tube: a feasibility study. Br J Anaesth. 2008 Sep;101(3):411-8. doi: 10.1093/bja/aen166. Epub 2008 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Endobronchial tube misplacement is serious complication during general anesthesia in pediatric patients. Correct placement of the endotracheal tube (ETT) in the trachea is crucial. Several methods have been suggested for determination of correct ETT placement. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes.', 'detailedDescription': 'Several methods have been suggested for determination of correct ETT placement. These include for example the marker method, the mainstem method or the formula method. However, to date, auscultation of the left and right lung is the standard of care and the only ubiquitary available method with an error rate of up to 12%. Electrical impedance tomography (EIT) is a new non-invasive method for evaluation of left and right lung ventilation. In this study the investigators investigate the potential role of EIT for proper placement of pediatric endotracheal tubes. For this purpose, pediatric patients are routinely intubated for cardiac catheterization using the mainstem method or 3xETT size method. Placement of the ETT is then verified by intraoperative fluoroscopy and lung ventilation is verified by EIT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent from the parents\n* endotracheal intubation with a standard endotracheal tube\n\nExclusion Criteria:\n\n* refusal of written informed consent\n* severe lung diseases\n* contraindication for use of electrical impedance tomography'}, 'identificationModule': {'nctId': 'NCT01237756', 'briefTitle': 'Electrical Impedance Tomography for Endotracheal Tube Placement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Electrical Impedance Tomography for Endotracheal Tube Placement in Pediatric Patients', 'orgStudyIdInfo': {'id': '198/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pediatric', 'interventionNames': ['Device: measurement of left and right lung ventilation']}], 'interventions': [{'name': 'measurement of left and right lung ventilation', 'type': 'DEVICE', 'otherNames': ['EIT, Draeger'], 'description': 'Patients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography', 'armGroupLabels': ['pediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Daniel Steinmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. med. Daniel Steinmann', 'oldOrganization': 'University Medical Center Freiburg'}}}}