Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 10:53 PM
Study NCT ID:
NCT01698892
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'whyStopped': 'End study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of dyspnea', 'timeFrame': '1 day', 'description': 'Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).'}], 'secondaryOutcomes': [{'measure': 'VAS Individual scores', 'timeFrame': '1 day', 'description': 'VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)'}, {'measure': 'Blood pressure', 'timeFrame': '1 day', 'description': 'Blood pressure (mean blood pressure measurements made before, during and after the exam)'}, {'measure': 'Desaturation frequency', 'timeFrame': '1 day', 'description': 'Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%'}, {'measure': 'heart rate', 'timeFrame': '1 day', 'description': 'Initial and maximum heart rate during bronchoscopy (continuous monitoring)'}, {'measure': 'OAAS Score', 'timeFrame': '1 day', 'description': 'OAAS Score after bronchoscopy'}, {'measure': 'Bronchoscopy duration', 'timeFrame': '1 day', 'description': 'Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)'}, {'measure': 'Comparison of midazolam total dose', 'timeFrame': '1 day', 'description': 'Comparison of midazolam total dose administered in each group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['I.V. sedation, midazolam, bronchoscopy'], 'conditions': ['Sedation During Bronchoscopy']}, 'descriptionModule': {'briefSummary': 'Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures.\n\nGood flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.\n\nWe thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged between 18 and 80, who will undergo bronchoscopy\n* FEV1≥ 50% of theorical value\n* Ambient air saturation at rest ≥ 94%\n* No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound\n* fasting for at least 6 hours\n* No indication against bronchoscopy, nor to premedication\n* Informed consent signed\n\nExclusion Criteria:\n\n* Pregnant or lactating, women\n* PAH patients\n* patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy\n* Patients with oral anticoagulants'}, 'identificationModule': {'nctId': 'NCT01698892', 'acronym': 'TORSIV', 'briefTitle': 'Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.', 'orgStudyIdInfo': {'id': 'RC12_0208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I.V. sedation', 'description': 'Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation', 'interventionNames': ['Drug: I.V Sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sublingual sedation', 'description': 'Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group', 'interventionNames': ['Drug: sublingual sedation']}], 'interventions': [{'name': 'I.V Sedation', 'type': 'DRUG', 'description': 'Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group', 'armGroupLabels': ['I.V. sedation']}, {'name': 'sublingual sedation', 'type': 'DRUG', 'description': 'Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group', 'armGroupLabels': ['sublingual sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Cavailles', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}