Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT01742195
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-10', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient comfort and satisfaction', 'timeFrame': 'Two hours after endobronchial ultrasound', 'description': 'Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.'}], 'secondaryOutcomes': [{'measure': "Physician's assessment of patient comfort", 'timeFrame': 'Immediately after the procedure (within 10 minutes)', 'description': 'Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.'}, {'measure': 'Duration of endobronchial ultrasound procedure', 'timeFrame': 'During the procedure', 'description': 'Measured in minutes.'}, {'measure': 'Total doses of sedation', 'timeFrame': 'Immediately after the procedure (within 10 minutes)', 'description': 'Total doses of each sedative used will be recorded.'}, {'measure': 'Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia', 'timeFrame': 'During the procedure and up to two hours after'}, {'measure': 'Proportion of adequate cytology specimens in each group', 'timeFrame': 'Days after the procedure (results usually available within 10 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endobronchial ultrasound', 'Bronchoscopy', 'Patient satisfaction'], 'conditions': ['Satisfaction']}, 'referencesModule': {'references': [{'pmid': '26705010', 'type': 'DERIVED', 'citation': 'Beaudoin S, Martel S, Pelletier S, Lampron N, Simon M, Laberge F, Delage A. Randomized Trial Comparing Patient Comfort Between the Oral and Nasal Insertion Routes for Linear Endobronchial Ultrasound. J Bronchology Interv Pulmonol. 2016 Jan;23(1):39-45. doi: 10.1097/LBR.0000000000000249.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if the insertion of the linear endobronchial ultrasound bronchoscope is more comfortable for patients when done through the nose compared to its insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.', 'detailedDescription': 'Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.\n\nIn order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years of age\n* patients referred for a first linear endobronchial ultrasound\n\nExclusion Criteria:\n\n* Patients who previously underwent an EBUS\n* Patients intubated with an endotracheal tube\n* Patients under the age of 18\n* Patients unable to provide informed consent\n* Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents)\n* Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.'}, 'identificationModule': {'nctId': 'NCT01742195', 'briefTitle': 'Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound', 'orgStudyIdInfo': {'id': 'IUCPQ-20871'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nasal EBUS insertion', 'description': 'Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.', 'interventionNames': ['Procedure: Nasal EBUS insertion']}, {'type': 'OTHER', 'label': 'Oral EBUS insertion', 'description': 'Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.', 'interventionNames': ['Procedure: Oral EBUS insertion']}], 'interventions': [{'name': 'Oral EBUS insertion', 'type': 'PROCEDURE', 'armGroupLabels': ['Oral EBUS insertion']}, {'name': 'Nasal EBUS insertion', 'type': 'PROCEDURE', 'armGroupLabels': ['Nasal EBUS insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Stéphane Beaudoin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}, {'name': 'Simon Martel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}, {'name': 'Antoine Delage, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antoine Delage', 'investigatorAffiliation': 'Laval University'}}}}