Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02857504
Status:
UNKNOWN
Last Update Posted:
2017-04-17
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Lung Ventilation: Double Lumen Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-06-29', 'releaseDate': '2017-04-16'}], 'estimatedResultsFirstSubmitDate': '2017-04-16'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-14', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation', 'timeFrame': 'intraoperative', 'description': 'The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['double lumen tube', 'hook'], 'conditions': ['Double Lumen Tube']}, 'referencesModule': {'references': [{'pmid': '19752725', 'type': 'RESULT', 'citation': 'Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.'}, {'pmid': '23089502', 'type': 'RESULT', 'citation': 'Pedoto A. How to choose the double-lumen tube size and side: the eternal debate. Anesthesiol Clin. 2012 Dec;30(4):671-81. doi: 10.1016/j.anclin.2012.08.001.'}, {'pmid': '11932162', 'type': 'RESULT', 'citation': 'Hofmann HS, Rettig G, Radke J, Neef H, Silber RE. Iatrogenic ruptures of the tracheobronchial tree. Eur J Cardiothorac Surg. 2002 Apr;21(4):649-52. doi: 10.1016/s1010-7940(02)00037-4.'}, {'pmid': '18945364', 'type': 'RESULT', 'citation': 'Prunet B, Lacroix G, Asencio Y, Cathelinaud O, Avaro JP, Goutorbe P. Iatrogenic post-intubation tracheal rupture treated conservatively without intubation: a case report. Cases J. 2008 Oct 22;1(1):259. doi: 10.1186/1757-1626-1-259.'}, {'pmid': '9477054', 'type': 'RESULT', 'citation': 'Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.'}, {'pmid': '2520925', 'type': 'RESULT', 'citation': 'Slinger PD. Fiberoptic bronchoscopic positioning of double-lumen tubes. J Cardiothorac Anesth. 1989 Aug;3(4):486-96. doi: 10.1016/s0888-6296(89)97987-8.'}, {'pmid': '17021522', 'type': 'RESULT', 'citation': 'Cohen E. Double-lumen tube position should be confirmed by fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2004 Feb;17(1):1-6. doi: 10.1097/00001503-200402000-00002.'}, {'pmid': '10392687', 'type': 'RESULT', 'citation': 'Fitzmaurice BG, Brodsky JB. Airway rupture from double-lumen tubes. J Cardiothorac Vasc Anesth. 1999 Jun;13(3):322-9. doi: 10.1016/s1053-0770(99)90273-2. No abstract available.'}, {'pmid': '25489763', 'type': 'RESULT', 'citation': 'Dumans-Nizard V, Parquin JF, Moyer JD, Dreyfus JF, Fischler M, Le Guen M. Left double-lumen tube with or without a carinal hook: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jun;32(6):418-24. doi: 10.1097/EJA.0000000000000201.'}]}, 'descriptionModule': {'briefSummary': 'One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS).\n\nOLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.', 'detailedDescription': 'One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS)(1).\n\nOLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).\n\nThere are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).\n\nSome severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).\n\nEach anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned thoracotomy or VATS surgical technique\n* with ASA (American Society of Anesthesiologist) physical status 1-3.\n\nExclusion Criteria:\n\n* ASA\\>3,\n* severe heart illness (NYHA \\>3),\n* severe pulmonary obstructive disease (FEV1\\<40%),\n* neurologic disorders and\n* patients with other respiratory or lung disease.'}, 'identificationModule': {'nctId': 'NCT02857504', 'briefTitle': 'One Lung Ventilation: Double Lumen Tube', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook', 'orgStudyIdInfo': {'id': '137/02/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'double lumen tube with a hook', 'description': 'The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.', 'interventionNames': ['Device: double lumen tube with a hook']}, {'type': 'OTHER', 'label': 'double lumen tube without a hook', 'description': 'Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.', 'interventionNames': ['Device: double lumen tube without a hook']}], 'interventions': [{'name': 'double lumen tube with a hook', 'type': 'DEVICE', 'description': 'The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.', 'armGroupLabels': ['double lumen tube with a hook']}, {'name': 'double lumen tube without a hook', 'type': 'DEVICE', 'description': 'Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.', 'armGroupLabels': ['double lumen tube without a hook']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Lea Andjelkovic, MD', 'role': 'CONTACT', 'email': 'lea.andjelkovic@gmail.com', 'phone': '0038641254978'}], 'facility': 'University Medical Center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Lea Andjelkovic, MD', 'role': 'CONTACT', 'email': 'lea.andjelkovic@gmail.com', 'phone': '0038641254978'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lea Andjelkovic', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-16', 'type': 'RELEASE'}, {'date': '2017-06-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lea Andjelkovic, MD, University Medical Centre Ljubljana'}}}}