Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT06228703
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2024-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effects of Different Flow Settings on Lung Impedance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jie_Li@rush.edu', 'phone': '3125634643', 'title': 'Jie Li', 'organization': 'Rush University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was conducted in healthy adult volunteers in a controlled laboratory environment, which may limit generalizability to clinical populations. The short intervention duration and immediate outcome assessments do not allow evaluation of longer-term effects.'}}, 'adverseEventsModule': {'timeFrame': 'From the start of the experimental session until completion of all flow conditions (up to 4 hours)', 'description': "Adverse events were monitored throughout the experimental session by direct observation. The study involved healthy volunteers undergoing brief respiratory interventions, with no clinical treatments or follow-up. No differences exist between the study's definitions of adverse events and ClinicalTrials.gov definitions.", 'eventGroups': [{'id': 'EG000', 'title': 'Total Study Population', 'description': 'This randomized crossover study assigned all participants to receive each of the study treatments in a randomized order. All 26 participants contributed baseline demographic data to this single group.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'This randomized crossover study assigned all participants to receive each of the study treatments in a randomized order. All 26 participants contributed baseline demographic data to this single group.'}], 'classes': [{'title': 'EELI change with HFNC 20 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '9', 'spread': '44', 'groupId': 'OG000'}]}]}, {'title': 'EELI change with HFNC 40 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '74', 'spread': '80', 'groupId': 'OG000'}]}]}, {'title': 'EELI change with HFNC 60 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '132', 'spread': '104', 'groupId': 'OG000'}]}]}, {'title': 'EELI change with HFNC 20 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '7', 'spread': '44', 'groupId': 'OG000'}]}]}, {'title': 'EELI change with HFNC 40 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '71', 'spread': '71', 'groupId': 'OG000'}]}]}, {'title': 'change with HFNC 60 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '111', 'spread': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': "End-expiratory lung impedance (EELI) was measured continuously using electrical impedance tomography (EIT). For each flow-setting condition, EELI values were averaged over a stable 1-minute period. The outcome represents the change in EELI (in arbitrary impedance units) from each participant's baseline measurement prior to intervention. Positive values indicate an increase in end-expiratory lung volume compared to baseline, while negative values indicate a decrease. 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All 26 participants contributed baseline demographic data to this single group.'}], 'classes': [{'title': 'Changes in respiratory rates at HFNC 20 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Changes in respiratory rates at HFNC 40 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Changes in respiratory rates at HFNC 60 L/min compared to baseline for HFT device', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Changes in respiratory rates at HFNC 20 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Changes in respiratory rates at HFNC 40 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Changes in respiratory rates at HFNC 60 L/min compared to baseline for AIRVO device', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': 'Respiratory rate was measured as breaths per minute. Change was calculated as the value during each HFNC flow condition minus the baseline respiratory rate. Positive values indicate an increase in respiratory rate, and negative values indicate a decrease.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants (n=26) were included in this baseline analysis.'}, {'type': 'SECONDARY', 'title': "Subject's Comfort Level", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'This randomized crossover study assigned all participants to receive each of the study treatments in a randomized order. All 26 participants contributed baseline demographic data to this single group.'}], 'classes': [{'title': 'Comfort level at HFNC 20 L/min for HFT device', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '10'}]}]}, {'title': 'Comfort level at HFNC 40 L/min for HFT device', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'Comfort level at HFNC 60 L/min for HFT device', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '8'}]}]}, {'title': 'Comfort level at HFNC 20 L/min for AIRVO device', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '9'}]}]}, {'title': 'Comfort level at HFNC 40 L/min for AIRVO device', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': 'Comfort level at HFNC 60 L/min for AIRVO device', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 hours', 'description': 'Comfort level reported by participants using a visual numerical scale ranging between 0 (extreme discomfort) and 10 (very comfortable) at the end of each flow setting', 'unitOfMeasure': 'Score (0-10)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants (n=26) were included in this baseline analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Study Population', 'description': 'This randomized crossover study evaluated two high-flow nasal cannula devices. All 26 participants completed the three prespecified flow-setting conditions for each device in a randomized sequence.'}], 'periods': [{'title': 'Device A - Flow Setting 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Device A - Flow Setting 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Device A - Flow Setting 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Device B - Flow Setting 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Device B - Flow Setting 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Device B - Flow Setting 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult healthy volunteers were recruited at a single academic medical center through posted study invitations and direct approach. Individuals expressing interest were screened for eligibility, and those who met inclusion criteria provided written informed consent prior to participation', 'preAssignmentDetails': 'Adult healthy volunteers were recruited at a single academic medical center through posted study invitations and direct approach. Individuals expressing interest were screened for eligibility, and those who met inclusion criteria provided written informed consent prior to participation'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Study Population', 'description': 'This randomized crossover study assigned all participants to receive each of the study treatments in a randomized order. All 26 participants contributed baseline demographic data to this single group.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'description': 'age', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled participants (n=26) were included in this baseline analysis.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This table reports participant self-identified race and ethnicity categories as collected during the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled participants (n=26) were included in this baseline analysis.'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000', 'lowerLimit': '157', 'upperLimit': '170'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'All enrolled participants (n=26) were included in this baseline analysis.'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '59.8', 'upperLimit': '83.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-12', 'size': 1248459, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-03T19:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-01-18', 'resultsFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-03', 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)', 'timeFrame': 'Up to 4 hours', 'description': "End-expiratory lung impedance (EELI) was measured continuously using electrical impedance tomography (EIT). For each flow-setting condition, EELI values were averaged over a stable 1-minute period. The outcome represents the change in EELI (in arbitrary impedance units) from each participant's baseline measurement prior to intervention. Positive values indicate an increase in end-expiratory lung volume compared to baseline, while negative values indicate a decrease. EIT impedance units are dimensionless and device-specific and are used to represent relative changes in ventilation and lung volume."}], 'secondaryOutcomes': [{'measure': 'Changes in Respiratory Rates Compared to Baseline', 'timeFrame': 'Up to 4 hours', 'description': 'Respiratory rate was measured as breaths per minute. Change was calculated as the value during each HFNC flow condition minus the baseline respiratory rate. Positive values indicate an increase in respiratory rate, and negative values indicate a decrease.'}, {'measure': "Subject's Comfort Level", 'timeFrame': 'Up to 4 hours', 'description': 'Comfort level reported by participants using a visual numerical scale ranging between 0 (extreme discomfort) and 10 (very comfortable) at the end of each flow setting'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['high-flow nasal cannula', 'ventilation distribution', 'lung impedance'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28940962', 'type': 'BACKGROUND', 'citation': 'McKinstry S, Pilcher J, Bardsley G, Berry J, Van de Hei S, Braithwaite I, Fingleton J, Weatherall M, Beasley R. Nasal high flow therapy and PtCO2 in stable COPD: A randomized controlled cross-over trial. Respirology. 2018 Apr;23(4):378-384. doi: 10.1111/resp.13185. Epub 2017 Sep 22.'}, {'pmid': '30888444', 'type': 'BACKGROUND', 'citation': 'Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.'}, {'pmid': '36855198', 'type': 'BACKGROUND', 'citation': 'Li J, Albuainain FA, Tan W, Scott JB, Roca O, Mauri T. The effects of flow settings during high-flow nasal cannula support for adult subjects: a systematic review. Crit Care. 2023 Feb 28;27(1):78. doi: 10.1186/s13054-023-04361-5.'}]}, 'descriptionModule': {'briefSummary': "This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.", 'detailedDescription': "Background: High-flow nasal cannula (HFNC) is a device that can reduce the work of breathing (WOB) and improve oxygenation by providing a flow that matches or exceeds patient's peak inspiratory flow during tidal breathing. Despite its widespread use, there remains a lack of consensus regarding the optimal flow settings. Two new HFNC devices that can provide information regarding patient's peak tidal inspiratory flow breath by breath are recently available, which might help guide set and titrate the flow settings. This study aims to investigate the effects of different flow settings on lung impedance in a cohort of healthy volunteers by using the two new HFNC devices.\n\nMethods: This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between 21-65 years old\n\nExclusion Criteria:\n\n* Chronic pulmonary diseases, including COPD, interstitial lung disease, cystic fibrosis, etc.\n* Uncontrolled asthma;\n* Pregnancy\n* Subjects who have cold/flu symptoms (sore throat, runny nose, fever, chills, coughing)\n* Nose abnormalities that can affect the functionality of the nasal prongs'}, 'identificationModule': {'nctId': 'NCT06228703', 'briefTitle': 'The Effects of Different Flow Settings on Lung Impedance', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HFNC-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Airvo 3 high-flow nasal cannula device with flow set at 20 L/min', 'description': 'A new high-flow nasal cannula device (Airvo 3) will be used in the study, with the flow set at 20 L/min'}, {'type': 'NO_INTERVENTION', 'label': 'HFT 750 high-flow nasal cannula device with flow set at 20 L/min', 'description': 'A new high-flow nasal cannula device (HFT 750) will be used in the study, with the flow set at 20 L/min'}, {'type': 'EXPERIMENTAL', 'label': 'Airvo 3 high-flow nasal cannula device with flow set at 40 L/min', 'description': 'Airvo 3 will be used with the flow set at 40 L/min', 'interventionNames': ['Device: High-flow nasal cannula device with flow setting at 40 L/min or higher']}, {'type': 'EXPERIMENTAL', 'label': 'Airvo 3 high-flow nasal cannula device with flow set at 60 L/min', 'description': 'Airvo 3 will be used with the flow set at 60 L/min', 'interventionNames': ['Device: High-flow nasal cannula device with flow setting at 40 L/min or higher']}, {'type': 'EXPERIMENTAL', 'label': 'HFT 750 high-flow nasal cannula device with flow set at 40 L/min', 'description': 'HFT 750 will be used with the flow set at 40 L/min', 'interventionNames': ['Device: High-flow nasal cannula device with flow setting at 40 L/min or higher']}, {'type': 'EXPERIMENTAL', 'label': 'HFT 750 high-flow nasal cannula device with flow set at 60 L/min', 'description': 'HFT 750 will be used with the flow set at 60 L/min', 'interventionNames': ['Device: High-flow nasal cannula device with flow setting at 40 L/min or higher']}], 'interventions': [{'name': 'High-flow nasal cannula device with flow setting at 40 L/min or higher', 'type': 'DEVICE', 'otherNames': ['HFNC flow at 40 L/min or higher'], 'description': 'Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher', 'armGroupLabels': ['Airvo 3 high-flow nasal cannula device with flow set at 40 L/min', 'Airvo 3 high-flow nasal cannula device with flow set at 60 L/min', 'HFT 750 high-flow nasal cannula device with flow set at 40 L/min', 'HFT 750 high-flow nasal cannula device with flow set at 60 L/min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Forest Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University', 'geoPoint': {'lat': 41.87948, 'lon': -87.81367}}], 'overallOfficials': [{'name': 'JIE LI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}