Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT02363959
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hyperbaric Oxygen Therapy for Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scott.shofer@duke.edu', 'phone': '919-668-2402', 'title': 'Scott Shofer MD, PhD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Repeat bronchoscopy due to bleeding during biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Pathologic specimens will be examined for the presence of acute cellular rejection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Development of Clinically Significant Airway Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Development of Clinically Significant Lung Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'As defined by initiation of antimicrobials to treat the suspected organism.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Development of Bronchitis Obliterans Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'OG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bronchial Epithelial Gene Expression', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'FG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Medical instability', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.'}, {'id': 'BG001', 'title': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.\n\nEndobronchial Biopsy of Airway Epithelium: During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.65', 'spread': '14.80', 'groupId': 'BG000'}, {'value': '52.07', 'spread': '18.76', 'groupId': 'BG001'}, {'value': '52.86', 'spread': '18.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-01', 'size': 181476, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-24T12:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2015-02-10', 'resultsFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bronchial Epithelial Gene Expression', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.', 'timeFrame': '12 months', 'description': 'Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.'}, {'measure': 'Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy', 'timeFrame': '12 months', 'description': 'Pathologic specimens will be examined for the presence of acute cellular rejection.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Development of Clinically Significant Airway Stenosis', 'timeFrame': '12 months'}, {'measure': 'Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis', 'timeFrame': '12 months'}, {'measure': 'Number of Subjects With Development of Clinically Significant Lung Infection', 'timeFrame': '12 months', 'description': 'As defined by initiation of antimicrobials to treat the suspected organism.'}, {'measure': 'Number of Subjects With Development of Bronchitis Obliterans Syndrome', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperbaric Oxygen', 'Lung Transplantation', 'Central Airway Stenosis', 'Airway Exudative Plaques', 'Hyperbaric Oxygen Therapy', 'Post-Lung Transplantation', 'Airway Ischemia', 'Endobronchial Biopsy', 'Bronchoscopy'], 'conditions': ['Disorder Related to Lung Transplantation', 'Central Airway Stenosis', 'Airway Exudative Plaques', 'Airway Complications Post-Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '33518452', 'type': 'RESULT', 'citation': 'Kraft BD, Mahmood K, Harlan NP, Hartwig MG, Snyder LD, Suliman HB, Shofer SL. Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation. J Heart Lung Transplant. 2021 Apr;40(4):269-278. doi: 10.1016/j.healun.2021.01.008. Epub 2021 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on airway complications in post-lung transplant recipients with evidence of restricted levels of blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in the early post-transplant period will be randomized to HBOT or usual care and followed clinically for 12 months following randomization. The investigators hypothesize that HBOT will decrease the number of airway complications in the treated subjects.', 'detailedDescription': 'Hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician. The HBOT procedure used for this study will be identical to that used for clinical practice in the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology, including the oxygen that is used in the chamber. Patients will receive treatment through the regular clinical hyperbaric service. These are routine, not special, treatment sessions and they will receive them alongside other Duke University Medical Center patients being treated for other reasons. The medical grade oxygen used is a part of the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology hyperbaric chamber system.\n\nWhile the patients randomized to receive usual care will not undergo HBOT, both study groups will receive standard serial bronchoscopies for airway clearance and for the collection of bronchoalveolar lavage fluid for culture data, due to the high rate of infection in lung transplant patients. All subjects will undergo the standard surveillance bronchoscopies every 3 to 4 weeks (x3) for clearance of the exudate from the airway, as well as monitoring progression of the airway abnormalities. As participants in this study, an, endobronchial biopsy of the airway epithelium will be performed at the main carina to collect a sample of recipient epithelium as well as at the first subcarina for each donor lung. Three samples will be collected from each of the biopsy sites. These samples are small (1 to 2 mm) and are thought to have a minimal clinical risk of minor bleeding associated with the procedure. Biopsy will add roughly 3 minutes total to each procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-lung transplant patient\n* Extensive exudative plaques at 1 month bronchoscopy\n* No sign of airway improvement, or showing worsening of plaques at follow-up bronchoscopy 2-3 weeks after 1 month bronchoscopy.\n\nExclusion Criteria:\n\n* Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%\n* Use of extracorporeal membrane oxygenation\n* Use of inhaled nitric oxide\n* Presence of pneumothorax\n* Pregnancy\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02363959', 'briefTitle': 'Hyperbaric Oxygen Therapy for Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis', 'orgStudyIdInfo': {'id': 'Pro00055849'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen, Airway Biopsy', 'description': 'The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.\n\nDuring standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.', 'interventionNames': ['Drug: Hyperbaric Oxygen Therapy', 'Procedure: Endobronchial Biopsy of Airway Epithelium']}, {'type': 'OTHER', 'label': 'No Hyperbaric Oxygen, Airway Biopsy', 'description': 'No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure.', 'interventionNames': ['Procedure: Endobronchial Biopsy of Airway Epithelium']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'DRUG', 'otherNames': ['HBOT', 'Hyperbaric Oxygen'], 'description': '2 hours of breathing \\>99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.', 'armGroupLabels': ['Hyperbaric Oxygen, Airway Biopsy']}, {'name': 'Endobronchial Biopsy of Airway Epithelium', 'type': 'PROCEDURE', 'otherNames': ['Airway Biopsy'], 'description': 'During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.', 'armGroupLabels': ['Hyperbaric Oxygen, Airway Biopsy', 'No Hyperbaric Oxygen, Airway Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Scott Shofer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}