Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-18 @ 12:56 AM
Study NCT ID:
NCT01171560
Status:
UNKNOWN
Last Update Posted:
2010-08-12
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the EZ Blocker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-10-18', 'releaseDate': '2010-09-27'}, {'resetDate': '2011-06-03', 'releaseDate': '2011-05-03'}, {'resetDate': '2011-06-30', 'releaseDate': '2011-06-08'}, {'resetDate': '2012-01-09', 'releaseDate': '2011-12-05'}, {'resetDate': '2014-04-24', 'releaseDate': '2014-03-25'}], 'estimatedResultsFirstSubmitDate': '2010-09-27'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-11', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from intubation to ventilation:', 'timeFrame': '5 minutes', 'description': 'is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?'}], 'secondaryOutcomes': [{'measure': 'postoperative sore throat or croakiness', 'timeFrame': '2 minutes', 'description': 'Documentation of sore throat and croakiness by questioning the patients the day after surgery'}, {'measure': 'resistance to dislocation', 'timeFrame': '10 minutes', 'description': 'Which device, double-lung-tube or EZ-Blocker, is more resistant to dislocation in endotracheal/endobronchial position, especially when the patient is moved from dorsal to lateral position?'}, {'measure': 'Peripheral oxygen saturation (SpO2)', 'timeFrame': '3 hours', 'description': 'Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EZ Blocker', 'Double-lumen Tube', 'Airway', 'thoracic surgery', 'time for intubation', 'blind insertion', 'conditions of surgery', 'postoperative sore throat', 'postoperative hoarseness'], 'conditions': ['Intubation', 'Thoracic Surgery', 'One-lung Ventilation']}, 'referencesModule': {'references': [{'pmid': '21493621', 'type': 'DERIVED', 'citation': 'Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.\n\nDue to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.\n\nThe EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.\n\nDue to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* thoracic surgery with requiring single lung ventilation in lateral position\n* ASA Status 1-3\n* Oral and written consent to participation\n* Age 18- 90\n\nExclusion Criteria:\n\n* Contraindications against placing a double lume tube, like tracheal lesions, etc.\n* Thoracic surgery within the last four weeks\n* Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc\n* BMI higher than 45\n* Patients with a previous diagnoses or suspected difficult airway'}, 'identificationModule': {'nctId': 'NCT01171560', 'briefTitle': 'Evaluation of the EZ Blocker', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®', 'orgStudyIdInfo': {'id': '096/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EZ Blocker', 'description': 'Patients assigned to the EZ group will be intubated using a conventional tube in an adequate size as it is standard of care and single lung ventilation will be provided using the EZ-Blocker.', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double lumen tube', 'description': 'The patients assigned to the "double lume tube" group will be intubated using the double lume tube in an adequate size as it is standard of care.', 'interventionNames': ['Procedure: endotracheal intubation']}], 'interventions': [{'name': 'endotracheal intubation', 'type': 'PROCEDURE', 'description': 'The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.', 'armGroupLabels': ['Double lumen tube', 'EZ Blocker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Kurt Rützler, M.D.', 'role': 'CONTACT', 'email': 'kurt.ruetzler@meduniwien.ac.at'}, {'name': 'Kurt Rützler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Georg Grubhofer, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helmut Hager, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'General Hospital of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Kurt Rützler, M.D.', 'role': 'CONTACT', 'email': 'kurt.ruetzler@meduniwien.ac.at', 'phone': '00436643855257'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Cardio-, Thoracic- and Vascular- Anesthesia', 'oldOrganization': 'Medical University of Vienna'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-09-27', 'type': 'RELEASE'}, {'date': '2010-10-18', 'type': 'RESET'}, {'date': '2011-05-03', 'type': 'RELEASE'}, {'date': '2011-06-03', 'type': 'RESET'}, {'date': '2011-06-08', 'type': 'RELEASE'}, {'date': '2011-06-30', 'type': 'RESET'}, {'date': '2011-12-05', 'type': 'RELEASE'}, {'date': '2012-01-09', 'type': 'RESET'}, {'date': '2014-03-25', 'type': 'RELEASE'}, {'date': '2014-04-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kurt Rutzler, Physician, Medical University of Vienna'}}}}