Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT01853904
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2013-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2013-04-05', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Syringe Suction versus Channel Suction to retrieve volume', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Syringe suction versus Channel suction to retrieve alveolar cells', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bronchoscopy', 'BAL', 'Suction'], 'conditions': ['Bronchoscopy']}, 'descriptionModule': {'briefSummary': 'Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a bronchus, instilling saline, and removing the saline via suction. Two techniques are currently used for suctioning: syringe based and channel suction.\n\nThe investigators concern is that channel suction creates too much force and there is collapsing of the airways which results in decreased fluid removal as well as cell sampling. The investigators propose that syringe based suctioning will not only return more of the instilled fluid but also more cells from the alveoli.', 'detailedDescription': 'The pulmonary segment with the most disease on imaging will be the segment sampled. The scope will be wedged in the airway leading to that segment and 100mL of saline will be instilled into the selected segment and collected via the syringe based or channel based suction. Prior to unwedging, another 100mL of saline will be instilled into the same segment and will be collected using the alternative method. There will not be randomization, but the investigators will alternate which method is used first to eliminate confounding variables. All patients will receive both modalities of suctioning. The wall suction used for the channel suction will be set at 80 mm Hg. Syringe based suctioning will be performed with 20mL syringe. Total amount of fluid collected will be recorded and samples will be sent for cell count and differential as well as Gram stain and culture. Results of the two techniques will then be compared to determine which is the superior suctioning modality for BAL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bronchoscopy scheduled\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01853904', 'briefTitle': 'Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Utility of Syringe Based Suction Versus Channel Suction in Bronchoalveolar Lavage', 'orgStudyIdInfo': {'id': '2296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Channel Suction first', 'description': 'This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen.', 'interventionNames': ['Procedure: Bronchoscopy/ BAL with Channel Suction', 'Procedure: Bronchoscopy/BAL with Syringe Suction']}, {'type': 'OTHER', 'label': 'Syringe Suction first', 'description': 'This arm is for patients who will receive syringe suction first to obtain the specimen then channel suction to obtain the specimen.', 'interventionNames': ['Procedure: Bronchoscopy/ BAL with Channel Suction', 'Procedure: Bronchoscopy/BAL with Syringe Suction']}], 'interventions': [{'name': 'Bronchoscopy/ BAL with Channel Suction', 'type': 'PROCEDURE', 'description': 'The wall suction used for the channel suction will be set at 80 mm Hg. This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen.', 'armGroupLabels': ['Channel Suction first', 'Syringe Suction first']}, {'name': 'Bronchoscopy/BAL with Syringe Suction', 'type': 'PROCEDURE', 'description': 'Syringe based suctioning will be performed with 20mL syringe.', 'armGroupLabels': ['Channel Suction first', 'Syringe Suction first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OUHSC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Brent Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}