Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02040961
Status:
TERMINATED
Last Update Posted:
2016-10-31
First Post:
2014-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the the ETView Double-lumen Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'An incident, burned tube, happened before intubation. The promoter decided to stop the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-28', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of insertion', 'timeFrame': '300 seconds', 'description': 'Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy'}], 'secondaryOutcomes': [{'measure': 'Ease of use evaluated by the anesthesiologist', 'timeFrame': '3 hours', 'description': 'Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult)'}, {'measure': 'Quality of lung collapse', 'timeFrame': '3 hours', 'description': 'Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation)'}, {'measure': 'Rate of misplacement occurring after patients removal from dorsal to lateral position', 'timeFrame': '1 hour'}, {'measure': 'Rate of misplacement, occurring during surgery', 'timeFrame': '3 hours'}, {'measure': 'Rate of requirement to a conventional double lumen tube', 'timeFrame': '3 hours', 'description': 'ETView Double-Lumen Tube is not well positioned. It is withdrawn and replaced by a conventional double lumen tube'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients', 'Undergoing', 'Elective', 'Thoracic', 'Surgery'], 'conditions': ['Tracheal Intubation']}, 'descriptionModule': {'briefSummary': 'The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective thoracic surgery with anticipated use of a DLT\n\nExclusion Criteria:\n\n* left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus\n* proximal left bronchial lesion\n* anatomical abnormality of the bronchial tree\n* suspicion of difficult mask ventilation or intubation'}, 'identificationModule': {'nctId': 'NCT02040961', 'acronym': 'ETView1', 'briefTitle': 'Assessment of the the ETView Double-lumen Tube', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Assessment of the the ETView Double-lumen Tube', 'orgStudyIdInfo': {'id': '2012/64'}, 'secondaryIdInfos': [{'id': '2012-A01552-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EtView', 'description': 'Use of ETVew double-lumen tube', 'interventionNames': ['Device: ETView Double-Lumen Tube']}], 'interventions': [{'name': 'ETView Double-Lumen Tube', 'type': 'DEVICE', 'description': 'Tracheal intubation is performed using a ETView Double-Lumen Tube', 'armGroupLabels': ['EtView']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Virginie Dumans-Nizard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}